NCT05542407Phase 1Recruiting
UNC Lineberger Comprehensive Cancer Center · Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina
Endometrial cancer (EC) is the fourth most common cancer in United States women, and alarmingly, the frequency and mortality from EC continues to rise, in part due to the obesity epidemic. Obese women with EC have a 6.3-fold increased risk of death from this disease, as compared to their non-obese counterparts. Patients with advanced/recurrent EC are unlikely to be cured by surgery, conventional chemotherapy (paclitaxel + carboplatin is the standard first-line treatment), radiation, or a combination of these. Thus, new treatments for EC are desperately needed as well as a better understanding of the impact of obesity on EC biology and treatment.
The purpose of this study is to test the safety of a combination of treatments, atezolizumab and ONC201, given based on body weight, to treat endometrial cancer. Using the combination of atezolizumab and ONC201, has not been approved by the Food and Drug Administration (FDA) for the treatment of endometrial cancer. This clinical trial will examine the treatment of atezolizumab + ONC201 in obese and non-obese subjects with metastatic/recurrent EC.
Eligibility: 18 Years to · Female · In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Inclusion Criteria
1. Ability to understand and willingness to sign a written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
2. Age ≥ 18 years at the time of consent.
3. ECOG Performance Status of 0, 1, or 2
4. Histologically confirmed metastatic or recurrent EC (endometrioid, carcinosarcoma, serous, clear cell, adeno-squamous and mixed histologies).
5. Subjects must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria
6. Must have radiographic disease progression after at least 1 line of systemic cytotoxic therapy for metastatic disease or with progression within 12 months of completing adjuvant chemotherapy.
7. Life expectancy of at least 3 months.
8. Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 72 hours prior to initiating study treatment.
Exclusion Criteria
1. Prior treatment with ONC201.
2. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including antiCTLA-4, and anti PD-L1 therapeutic antibodies
3. Treatment with another investigational agent or participation in another clinical trial within the last 28 days prior to initiating protocol therapy.
4. Subjects who have had chemotherapy or radiotherapy within 4 weeks prior to study treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to initiating protocol therapy.
5. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of protocol therapy Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
6. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \[IL-2\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of protocol therapy.
7. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti TNF-agents) within 2 weeks prior to initiation
NCT07134192NARecruiting
University of Aarhus · Aarhus University Hospital, Aarhus N
This is a Danish national multicenter prospective cohort study to evaluate if fluorescence-guided surgery (FGS) using indocyanine green (ICG) can reduce the rate of positive margins following sarcoma resection.
Eligibility: 18 Years to · All · * Biopsy verified intermediate-to-high grade sarcoma of theextremity or trunk wall
* Age\>18 years old
* Tumor operable
* Curative intent at time of surgery
* Consent of patient
NCT07089992Phase 2Recruiting
Memorial Sloan Kettering Cancer Center · Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey
The purpose of the study is to find out if pembrolizumab is a useful treatment that causes few or mild side effects in people with ultra-rare sarcoma. The researchers will also study how the immune system responds to the study treatment.
Pembrolizumab is a type of drug called a PD-1 inhibitor. It is designed to block a protein called programmed cell death protein 1 (PD-1) that usually acts as a "brake" on the immune system. Blocking this protein is like releasing the brakes, so that the immune system can target cancer cells and destroy them.
Eligibility: 18 Years to · All · Inclusion:
* Patients must have pathologically confirmed diagnosis of one of the following:
1. Pleomorphic liposarcoma
2. PEComa (perivascular epithelial cell tumor)
3. Epithelioid sarcoma
4. CIC-rearranged sarcoma
5. SEF/LGFMS: Sclerosing epithelioid fibrosarcoma - low grade fibromyxoid sarcoma
* Molecular characterization of the tumor, if available, will be recorded. If no such molecular data are available, note as such.
* Patient should have recurrent or metastatic disease not judged to be curable with other means
* Patients must have progressed (in the opinion of the treating investigator) following the most recent line of therapy or stop prior therapy due to toxicity or patient choice. The reason for this progression or other reason for changing therapy must be documented, employing tumor measurements when available.
* Definition of Measurable Disease
* Measurable disease as per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions for a minimum of 3 months after completion of such therapy
* Patients with treated brain metastases are eligible if follow up brain imaging after CNS-directed therapy shows no evidence of progression at least 4 weeks after the completion of therapy as shown by follow up imaging before study screening
* One to 3 prior lines of therapy are permitted (including neoadjuvant/adjuvant or metastatic/recurrent disease)
* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible. Patients with alopecia and other toxicities considered clinically nonsignificant and/or stable on supportive therapy, as determined by the investigator, are also permitted on study.
* Administration of killed vaccines is allowed
* Age ≥ 18 years of age.
* ECOG Performance Status 0-1 (Karnofsky 70-100)
* Required organ function (specimens to be collected within 14 days of the start of the study intervention)
* Adequate hematologic function, defined as:
* Absolute neutrophil count (ANC) ≥ 1,000 cells/mm\^3
* Platelets ≥ 100,000 cells/mm\^3
* Hemoglobin ≥ 9 g/dl
* Adequate renal function defined, as:
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert disease who have bilirubin level ≤ 3 x ULN may be enrolled)
* AST and ALT ≤3 x institutional ULN
* Adequate cardiac function, defined as: class II or better New York Heart Association (NYHA) Functional Classification.
* For patients with known HIV, HBV, and/or HCV infection \[HIV, HBV, and HCV testing do not need to be performed as part of the study; the below language provides guidelines for inclusivity of patients with known HIV, HBV, and/or HCV infection\]:
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and CD4+ T cell count of at least 350 cell/mm3 are eligible for this trial.
* HIV-infected patients with a history of either Kaposi sarcoma or Castleman disease are excluded from this study
* HIV-infected patients must not have had an AIDS defining opportunistic infection within the past 12 months
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Exclusion:
* No prior diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of study drug.
* No
NCT06111612Phase IIRecruiting
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai General Hospital, Shanghai, Shanghai Municipality
This study is a multicenter, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of an intensive conditioning regimen with thiotepa combined with busulfan, fludarabine, and cytarabine for allogeneic hematopoietic stem cell transplantation in the treatment of myeloid malignancies with extramedullary involvement. The conditioning regimen includes thiotepa at a dose of 5mg/kg/d from d -9 to d -8 (2 days), fludarabine at 30mg/m2/d from d -7 to d -3 (5 days), cytarabine at 1-1.5g/m2/d from d -7 to d -3 (5 days), and busulfan at 3.2mg/kg/d from d -5 to d -3 (3 days). Conditioning begins on day -9, and donor hematopoietic stem cell infusion is performed on day 0. All patients will undergo bone marrow examination on day 14 and day 28 post-transplant, followed by bone marrow examinations every 30 days within the first year after transplantation, and every 60 days within the second year after transplantation. If disease relapse is suspected during the follow-up period, bone marrow or extramedullary relapse site examinations will be conducted at any time. The primary study endpoints are the 1-year and 2-year progression-free survival (PFS) rates post-transplant. Secondary study endpoints include the incidence of acute graft-versus-host disease (GVHD) within 180 days post-transplant, cumulative relapse rates at 1 year and 2 years post-transplant, 1-year and 2-year overall survival (OS), graft-versus-host disease-free, relapse-free survival (GRFS), non-relapse mortality (NRM), cumulative incidence of chronic GVHD, and the incidence of Cytomegalovirus （CMV）and Epstein-Barr virus（EBV）reactivation within 1 year.
Eligibility: 18 Years to 55 Years · All · 1. Age between 18 and less than 55 years, regardless of gender.
2. Criteria for myeloid tumors with extramedullary involvement:
1. AML (Acute Myeloid Leukemia) with at least one extramedullary lesion achieving hematological remission (CR1 or CR2) after induction therapy.
2. MDS (Myelodysplastic Syndrome) with at least one extramedullary lesion and bone marrow blast percentage ≥ 5% achieving hematological CR after treatment; CMML (Chronic Myelomonocytic Leukemia) with at least one extramedullary lesion (diagnosed according to WHO standards) achieving hematological CR after treatment.
3. Control and remission of extramedullary lesions, including those in the central nervous system, testes, skin, and other extramedullary tissues.
4. Granulocytic sarcoma with or without bone marrow involvement, and achieving remission after treatment.
3. Patients must have a suitable hematopoietic stem cell donor:
1. Related donors must have at least 5/10 matches for HLA-A, -B, -C, -DQB1, and - DRB1.
2. Unrelated donors must have at least 8/10 matches for HLA-A, -B, -C, -DQB1, and
* DRB1.
4. Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2.
5. ECOG (Eastern Cooperative Oncology Group) performance status: 0-2.
6. Adequate liver, kidney, and cardiopulmonary function, meeting the following requirements:
1. Serum creatinine ≤ 1.5x ULN (the upper limit of normal).
2. Cardiac function: Ejection fraction ≥ 50%.
3. Baseline oxygen saturation \> 92%.
4. Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 2.0 x ULN.
5. Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 (Forced Expiratory Volume in 1 second) ≥ 50%.
7. Patients must have the ability to understand and be willing to participate in this study and sign an informed consent form.
NCT06389799Phase 2Recruiting
Lund University Hospital · Oslo University Hospital HF, Oslo
Dedifferentiated liposarcomas (DDLPS) are aggressive soft tissue sarcomas with no effective medical treatment options.
Immunotherapy with checkpoint inhibitors, so-called PD-1 inhibitors, have shown some effect in DDLPS in previous studies. Effect of immunotherapy can be improved by combining it with other types of tumor drugs. Medicines that inhibit signaling via the FGF receptor, so-called FGFR inhibitors, have shown a tumor-slowing effect in DDLPS in early studies. FGFR inhibitors can also induce changes that make the tumor more available to treatment with immunotherapy.
The study aims to investigate whether the combination of an FGFR inhibitor, pemigatinib, with a PD-1 inhibitor, retifanlimab can provide a tumor-slowing effect in patients with advanced DDLPS who have progressed on first-line treatment.
Eligibility: 18 Years to 100 Years · All · Participants will be eligible for the study if all of the following criteria are met:
1. Be 18 years of age or above, on day of signing informed consent.
2. Must be willing and able to provide written informed consent. Written informed consent must be signed and dated before the start of specific protocol procedures.
3. Must be willing and able to conform to and comply with all protocol requirements, including, all scheduled visits, protocol procedures, and the ability to swallow oral tablets.
4. Histologically confirmed DDLPS\*. Written pathology report indicating the diagnosis of DDLPS with positive MDM2 immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridization, polymerase chain reaction (PCR) or sequencing-based methods must be available.
5. Have the presence of at least 1 measurable lesion by CT per RECIST v1.1 that is considered non amenable to surgery or other curative treatments or procedures. Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measurable if progression has been demonstrated in the lesion.
6. Disease relapse or radiological progression, as determined by the Investigator, within the last 6 months after at least one line of systemic treatment.
a. Patients considered to be medically unfit for chemotherapy, as assessed by the sarcoma centre in charge of the patient's treatment, can be considered for the trial after discussion with the trial steering committee.
7. Be willing to provide tissue by core or excisional biopsy of a tumor lesion at the time points specified in the Trial Flow Chart. Archival tumor tissue can be used instead of pre-treatment biopsy. Biopsy will only be performed if the risk of complication is considered acceptable for the patient.
8. Have a performance status of 0-2 on the ECOG Performance Scale.
9. Patient must have adequate organ function as indicated by laboratory values obtained within 14 days of receiving the first dose of study drug (see study protocol)
10. Female patients of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
11. Female patients of childbearing potential must be willing to use a highly effective method of contraception, for the course of the study through 180 days after the last dose of study medication. Please refer to Section 5.3 for list of highly effective contraception.
12. Male patients must agree to use an highly effective method of contraception starting with the first dose of study therapy through 180 days after the last dose of study therapy.
NCT06083883Phase 1Recruiting
M.D. Anderson Cancer Center · MD Anderson Cancer Center, Houston, Texas
The goal of this clinical research study is to find a recommended dose of donated NK cells that can be given along with chemotherapy to patients with advanced cancers. The safety and effects of this therapy will also be studied.
Eligibility: 16 Years to 80 Years · All · 1. Patients with all cancer histology, with an HLA-A\*02:01, HLA-A\*02:05 or HLA-A\*02:06 positive and a positive expression of NY-ESO-1 (\>/= 50% tumor cells 2+ or 3+ by IHC) in the preenrollment tumor sample, for the dose escalation cohort. NY-ESO expression must be confirmed at MDACC prior to study entry.
2. Patients with histologically confirmed synovial sarcoma (cohort 1) or myxoid/round cell liposarcoma (cohort 2), with an HLA-A\*02:01, HLA-A\*02:05 or HLA-A\*02:06 positive and a positive expression of NY-ESO-1 (\>/= 50% tumor cells 2+ or 3+ by IHC) in the pre-enrollment tumor sample, for the expansion cohorts. Archival samples will be permitted for screening. NY-ESO expression must be confirmed at MDACC prior to study entry.
3. Patients must meet disease-specific eligibility criteria (see below).
4. Patients must have relapsed or become refractory to standard of care treatment and must have received at least one prior line of systemic therapy including either doxorubicin and/or ifosfamide (synovial sarcoma and MRCLS) or trabectedin (MRCLS).
5. Patients must have measurable disease per the RECIST v1.1 at enrollment.
6. Patients must be at least 2 weeks from last cytotoxic chemotherapy at the time of first administration of lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least 3 days prior to administration of lymphodepleting chemotherapy.
7. Patients must be at least 3 months from any cell therapy for malignancy.
8. Eastern Cooperative Oncology Group performance status 0-1 (Appendix A).
9. Adequate organ function at screening, as defined by the following:
1. Renal: Serum creatinine ≤ 1.5 mg/dL or estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration equation) ≥45 ml/min/1.73 m2
2. Hepatic: alanine transaminase (ALT)/aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x ULN if documented liver metastases, total bilirubin ≤ 1.5 mg/dL or ≤ 3.0 mg/dL for patients with Gilbert's Syndrome. No history of liver cirrhosis and no ascites.
3. Cardiac: Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no symptomatic cardiac disease or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)
4. Pulmonary: No clinically significant pleural effusion (per principal investigator \[PI\] judgement), and baseline oxygen saturation ≥ 92% on room air,
5. Hematological: absolute neutrophil count (ANC) ≥ 1000/mm3, platelet count ≥ 75,000/mm3, and hemoglobin ≥ 8 g/dL
6. Coagulation: International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 ULN. Patients on therapeutic doses of anticoagulation medication must have INR and/or aPTT ≤ the upper limit of the therapeutic range for intended use.
10. Able to provide written informed consent.
11. Aged 16-80 years.
12. Weight ≥40 kg.
13. All male and female patients who are able to have children must practice effective birth control while on study therapy and for up to 3 months post completion of study therapy. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence. Female patients who become pregnant or suspect pregnancy must immediately notify their doctor. Females patients who become pregnant will be taken off study. Men who are able to have children must use effective birth control while on the study therapy.
Acceptable forms of birth control for male patients include: condom with spermicide or abstinence. If the male patient fathers a child or suspects that
NCT03556228Phase 1, Phase 2Recruiting
VM Oncology, LLC · Providence Medical Foundation (site 209), Santa Rosa, California
This is a multicenter, open-label, Phase 1/2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists
Eligibility: 18 Years to 80 Years · All · Key
#. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma:
Phase 1 Dose Escalation only: Subjects with
(A) any advanced solid tumors of
1. Head and Neck Cancers ("HNC") (of any types),
2. Esophageal cancer,
3. Lung cancers (of any types),
4. Mesothelioma,
5. Pancreatic cancers,
Or,
(B) any NTRK1 gene fusion positive ("NTRK1+") solid tumors or lymphomas, that is relapsed, refractory or intolerant (R/R/I) to standard of care (SOC) and for which there is no approved or curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible.
Phase 2 Monotherapy and Combination with Pembrolizumab only:
Subjects must have
1. TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or,
2. any NTRK1+ solid tumors or lymphoma\*, that is R/R/I to SOC.
Key Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1.
* Able to swallow and retain oral medication.
* Subjects must either have available archival tumor tissue samples, or consent to tumor tissue sampling prior to the first dose.
* Adequate organ system function as defined as follows:
1. Absolute neutrophil count ≥1.5x10\^9/L
2. Hemoglobin ≥9g/dL
3. Platelets ≥100x10\^9/L
4. PT/INR, PTT ≤1.5xULN
5. Total bilirubin ≤1.5x ULN
6. AST, ALT ≤2.5xULN
7. Creatinine ≤1.2xULN for age, weight
8. Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL/min
Key
NCT06323239Phase 2Recruiting
Sun Yat-sen University · Sun Yat-sen University Cancer Center, Guangzhou, Guangdong
This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
Eligibility: 18 Years to 75 Years · All · * Diagnosed as recurrence/metastatic NPC
* Histopathological diagnosis of NPC(WHO II/III)
* ECOG 0-1 point
* No treatment to r/mNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
* No contraindications to immunotherapy and chemoradiotherapy;
* At least one lesion could receive SBRT safely;
* Subject must have a measurable target lesion based on RECIST v1.1;
* Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/ L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
* Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
* Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
* Take effective contraceptions during and three months after treatment;
* Patients must be informed of the investigational nature of this study and give written informed consent.
NCT06146764Phase IIRecruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong
Contrast-enhanced ultrasound (CEUS) can sensitively show the blood perfusion characteristics of thyroid nodules, which is a useful supplement to gray-scale ultrasound. However, there is no standard combined diagnostic method of gray-scale ultrasound and CEUS. Therefore, the aim of this study was to compare the diagnostic performance of the integrated scoring method and the up-and-down scoring method. This study was a multicenter retrospective clinical study and followed the Standards for Reporting of Diagnostic Accuracy Studies (version 2015). Inclusion criteria: 1) participants with at least one thyroid nodule larger than 5 mm confirmed by conventional ultrasound; 2) participants underwent gray-scale ultrasound, contrast-enhanced ultrasound and fine needle aspiration biopsy of the thyroid nodule successively; 3) participants have a final diagnosis of benign or malignant. Exclusion criteria included: 1) participants with cytologic findings of Bethesda I, III, or IV without definitive benign or malignant pathologic findings; 2) participants with a history of thyroid fine needle aspiration, ablation or surgery; 3) participants with low quality ultrasound images (e.g., severe artifacts or low image resolution). According to the American College of Radiology Thyroid Imaging Reporting and Data System, only one thyroid nodule with the highest point was included in each participant. A total of 600 participants from January 2018 to December 2022 were consecutively included in Sun Yat-sen Memorial Hospital of Sun Yat-sen University to form a training set (average age 48 years; Range 24-81 years old). A total of 200 subjects with thyroid nodules from January 2022 to December 2022 were consecutively included to form an external validation set in Houjie Hospital of Dongguan City, Guangdong Province (mean age 46 years; Range 30-74 years). The malignant risk of enrolled thyroid nodules and the necessity of biopsy were evaluated by integrated scoring method and up-and-down scoring method, respectively. The diagnostic performance and unnecessary biopsy rate of the above two methods were calculated and compared.
Eligibility: 18 Years to · All · * Participants with thyroid nodules with a solid component ≥5 mm confirmed by conventional ultrasound;
* Participants who underwent conventional ultrasound, contrast-enhanced ultrasound, and fine-needle aspiration biopsy;
* Participants with a final benign or malignant pathological results.
NCT06452602Phase 2Recruiting
Tianjin Medical University Cancer Institute and Hospital · Tianjin Cancer Hospital, Tianjin, Tianjin Municipality
This trial is conducted in patients with unresectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 60 patients with unresectable locally advanced esophageal cancer in Tianjin cancer hospital.
After 2 cycles of induction immunochemotherapy, 60 patients with ESCC will be divided into 2 groups (CR+PR group and SD+PD group) according to the efficacy of induction therapy. Patients in the CR+PR group will be treated with the same immunochemotherapy regimen plus concurrent radiotherapy (50.4Gy/1.8Gy/28f) . And immunotherapy will maintain for a maximum of 1 year. Patients in the SD+PD group will be treated with concurrent chemoradiotherapy (Radiotherapy: PTV/PGTV:50.4Gy/59.92Gy/28f and another chemotherapy regimen). Immunotherapy will not used during chemoradiotherapy because of immunotherapy resistance.
The trial can effectively stratify patients by induction immunochemotherapy, and a more appropriate treatment regimen for patients has the potential to further improve PFS and prolong OS in all patients.
Eligibility: 18 Years to 75 Years · All · 1. Volunteered to participate, cooperated with follow-up visits;
2. Aged 18 years or older, both male and female;
3. Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1( supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC );
4. Clinically staged as II-IVb inoperable locally advanced ESCC(including non-resectable, or with contraindications to or refusal of surgery);
5. ECOG performance status 0 or 1;
6. Presence of measurable and/or non-measurable lesions as defined by RECIST 1.1;
7. Haven't received any previous systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecularly targeted drug therapy, immunotherapy, biologic therapy, topical therapy and other investigational therapeutic agents);
8. Provide fresh or archived tumour tissue samples within 6 months (fresh samples preferred) for biomarker analysis (e.g.PD-L1). Sample types are formalin-fixed, paraffin-embedded \[FFPE\] tumour tissue blocks or at least 5 unstained, 3-5 μm thick FFPE tumour tissue sections;
9. Expected survival ≥ 3 months;
10. Adequate hematologic function, defined as ANC ≥1500/μl, platelet count ≥100,000/μl and hemoglobin count ≥9.0 g/dl or ≥5.6 mmol/l;
11. Adequate renal function, defined as creatinine ≤1.5× ULN or measured or calculated creatinine clearance ≥60 mL/min for those with creatinine levels \>1.5× ULN (Calculated from the Cockcroft-Gault formula);
12. Adequate hepatic function, defined as total bilirubin ≤1.5× ULN and ALT/AST/AKP levels ≤2.5× ULN and albumin ≥2.8 g/dl;
13. Adequate coagulation function, defined as INR ≤1.5× ULN and APTT≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as INR is within the therapeutic range;
14. Women of childbearing potential with a negative urine pregnancy test within 3 days before the first administration of the investigational drugs.
15. Documented informed consent.
NCT03545256NARecruiting
University Hospital, Montpellier · Gui de Chauliac Hospital, ENT Department 80 rue Augustin Fliche, Montpellier, Hérault
This is a single-center pilot study of open-label, non-randomized interventional research based on the outpatient management of 30 patients with T1-N0 or T2-N0 cancer in the oral cavity or oropharynx.
Eligibility: 18 Years to · All · * Male or female over 18 years old with no upper age limit
* Patient (s) affiliated to a social security system, or beneficiary of such a system
* Patient information and informed consent signed by the patient
* Patient no longer participating in another trial since legal time
* Patient with primary squamous cell carcinoma of the oral cavity or oropharynx documented by biopsy with histological analysis less than 1 month old
* Tumor operable by TNM stage, location and general condition of the patient
* Systematic Oto-Rhino-Laryngology panendoscopy eliminating a second synchronous tumor and establishing precisely the T
* Stage T1 or T2, N0 and M0
* Proposal by a multidisciplinary meeting for tumor surgery and GS technique
* Eligibility criteria for ambulatory surgery present
* Anesthetic criteria for eligibility for outpatient hospitalization (ref AFAR 29 (2010) 67-72, formalized expert recommendations) including ASA I, II and III score stable
* Patient able to understand the nature, purpose and methodology of the study
NCT05954702NARecruiting
Instituto do Cancer do Estado de São Paulo · Instituto do Cancer do Estado de São Paulo (ICESP), São Paulo, São Paulo
Esophagectomy has high rates of morbidity and mortality, in many cases due to esophagus reconstruction. Anastomotic leakage and fistula are the main esophagectomy complications. Many studies underwent to investigate the cause for anastomotic leakage after esophagectomy, however none of them conclude it is related to surgery or suture technique. However, it seems to be triggered by the ischemia caused after stomach mobilization to esophagus reconstruction, or even tension in the anastomosis.
Considering the post esophagectomy with gastroplasty high morbidity and mortality rates, strategies to create a new vascularization source and decrease anastomotic leakage rates is important. In this study researchers will evaluate whether a TRAM flap transfer supercharged is effective on decrease morbidity related to anastomosis ischemia in patients undergoing esophagectomy.
Eligibility: 18 Years to · All · * Diagnosis of esophageal malignancy cancer;
* Ability to understand and collaborate during treatment;
