[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hnpcc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hnpcc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100640741","phase-2-a-prospective-single-arm-phase-ii-clinical-trial-of-becotatug-vedotin-for-injection-combined-with-pucotenlimab-injection-as-a-first-line-treatment-for-platinum-intolerant-advanced-head-and-neck-squamous-cell-carcinoma-100640741",false,"NCT07628855","A Prospective, Single-arm, Phase II Clinical Trial of Becotatug Vedotin for Injection Combined With Pucotenlimab Injection as a First-line Treatment for Platinum-intolerant Advanced Head and Neck Squamous Cell Carcinoma","1. Histologically or cytologically diagnosed as squamous cell carcinoma, with the lesion site located in the oral cavity, oropharynx, hypopharynx, larynx, etc.;\n2. Recurrence and metastasis occurred after previous local treatment (surgery, radiotherapy, or concurrent chemoradiotherapy), with no possibility of cure, and no systemic treatment had been received previously, or previous induction or adjuvant treatment had been received, but the time from the end of the above treatment was ≥ 6 months;\n3. Existence of distant metastasis at the time of initial treatment, or extensive local lesion range, and not curable after MDT assessment;\n4. Patients who cannot tolerate platinum-based chemotherapy or do not accept cisplatin-based chemotherapy; Definition of cisplatin intolerance: Any of the following criteria met: age ≥ 70 years; mild or above hearing impairment; creatinine clearance rate \\\u003C 50 ml\u002Fmin (calculated according to the Cockcroft and Gault formula);\n5. PS score ≤ 2 points;\n6. At least one evaluable lesion according to the RECIST V1.1 standard;\n7. Normal organ function is sufficient:\n\nBone marrow: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelet count ≥ 100 × 109\u002FL, hemoglobin ≥ 90 g\u002FL, and no blood transfusion or biological response modifiers (such as granulocyte and erythropoietin growth factors) treatment within 14 days before the first administration; Liver: ALT and AST ≤ 2.5 times the upper limit of normal value (for subjects with liver metastasis, AST and ALT ≤ 5 × ULN), total bilirubin ≤ 1.5 times the upper limit of normal value (for subjects with liver metastasis or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤ 3 × ULN); serum albumin ≥ 30 g\u002FL; Kidneys: Creatinine clearance rate (Ccr) ≥ 30 mL\u002Fmin (calculated according to the Cockcroft and Gault formula)\n\nPatients with any of the following conditions are not eligible to be included in this study:\n\n1. Have a history of other primary malignant tumors within the past 3 years, except for skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, or in situ cervical cancer that have been completely resected;\n2. Have peripheral neuropathy of grade ≥ 2 (according to CTCAE v5.0);\n3. Have received any of the following treatments:\n4. Received intravenous antibiotic treatment within 7 days before the first administration;\n5. Received the study drug in another clinical trial within 4 weeks before the first administration;\n6. Have received attenuated live vaccines within 4 weeks before the first administration, or have been vaccinated with inactivated seasonal influenza vaccine or approved live virus-free COVID-19 vaccine;\n7. Have received systemic immunostimulatory drug treatment (including but not limited to interferons, interleukin-2, etc.) within 4 weeks before the first administration;\n8. Have undergone major surgical treatment (such as abdominal, thoracic surgeries, etc., excluding diagnostic punctures, infusion device implantation, or digestive tract implantation, etc.) within 4 weeks before the first administration, or are expected to undergo major non-tumor-related surgical treatment during the new adjuvant therapy period;\n9. Have clinically significant (i.e., active) cardiovascular diseases: cerebrovascular accidents\u002Fstrokes\u002F myocardial infarction within 6 months before enrollment, unstable angina pectoris, congestive heart failure (NYHA II grade and above), or require drug treatment for severe arrhythmias;\n10. Have evidence of active infections including hepatitis B (requiring both HBsAg positive, HBV DNA ≥ 2000 IU\u002Fml, and exclusion of hepatitis caused by other factors), hepatitis C (requiring both anti-HCV antibody positive and HCV RNA result greater than the detection limit), or human immunodeficiency virus (HIV) infection; Uncontrolled active bacterial, other viral, fungal, rickettsial or parasitic infections, unless treated and resolved before the administration of the study drug;\n11. Have a history of primary immunodeficiency or active autoimmune diseases, are using immunosuppressants or systemic hormone therapy (dose ≥ 10 mg\u002Fday of prednisone or equivalent hormone), and are still using it within 2 weeks before enrollment; Note: Type 1 diabetes, stable hypothyroidism due to hormone replacement therapy (including autoimmune thyroid disease-induced hypothyroidism), psoriasis, vitiligo or eczema patients can be enrolled, using local topical or inhaled glucocorticoids, or short-term (≤ 7 days) use of glucocorticoids for prevention or treatment of non-autoimmune and infrequent allergic diseases are excluded. ;\n12. Has a history of ≥ grade 3 allergic reaction to any component of Viberceptotota monoclonal antibody or Putilimab injection;\n13. Has a history of or is concurrently suffering from interstitial pneumonia, radiation pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.;\n14. Has a history of organ transplantation, including allogeneic peripheral stem cell or bone marrow transplantation. After careful assessment, patients who have undergone autologous hematopoietic stem cell transplantation for ≥ 5 years and have normal bone marrow function (not dependent on blood transfusion) can be considered to participate in the study; Other conditions that the investigator deems unsuitable for participation in this clinical trial, including but not limited to severe mental illness, central nervous system disorders, drug abuse, etc.","ALL","70 Years","105 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is a randomized, open-label, multi-center phase II trial evaluating the efficacy and safety of the becotatug vedotin in combination with pucotenlimab regimen in patients with advanced head and neck squamous cell carcinoma who are intolerant to platinum-based therapy.",[26],"HNPCC","NOT_YET_RECRUITING","2026-06-01",{"date":30,"type":31},"2026-06-05","ACTUAL",{"date":33,"type":20},"2026-05-14",{"date":35,"type":20},"2028-08-30",{"name":37,"class":38},"Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":74,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100570529","lynch-syndrome-x-talk-of-enteral-mucosa-with-immune-system-100570529","NCT06708429","Lynch Syndrome X-Talk of Enteral Mucosa With Immune System","Impact of Immune-surveillance on the Development of Colorectal Cancer in Patients With Lynch Syndrome","LYNX-EYE","Inclusion Criteria (for participants with Lynch syndrome):\n\n* Age ≥18 years\n* All sexes eligible\n* Established diagnosis of Lynch syndrome performed as part of clinical practice, with a germline pathogenic\u002Flikely pathogenic variant in one of the following genes: MLH1, MSH2, MSH6, PMS2, and EpCAM\n* Subjects with Lynch syndrome undergoing surveillance gastrointestinal endoscopy and\u002For surgery according to clinical practice\n* Fertile patients (both males and females) are eligible\n* Lactating women are eligible\n\nInclusion Criteria (for participants without Lynch syndrome):\n\n* Age ≥18 years\n* All sexes eligible\n* Patients with sporadic colorectal lesions, including colorectal cancer and colorectal adenomas\n* Healthy controls without colorectal cancer or adenomas undergoing lower gastrointestinal endoscopy for abdominal pain\n* PREMM5 \\\u003C 2.5 \\[PREMM5 is an online, free-to-use, clinical prediction algorithm that estimates the cumulative probability of an individual carrying a germline mutation in the mismatch repair genes responsible for Lynch syndrome\\].\n\nExclusion Criteria (for participants with or without Lynch syndrome):\n\n* Age \\\u003C 18 years;\n* Diseases that are known to predispose to colorectal cancer (personal past or recent history of inflammatory bowel disease);\n* Patients unable\u002Funwilling to provide consent;\n* Pregnancy","18 Years",{"count":49,"type":20},300,"OBSERVATIONAL","Lynch syndrome (OMIM #120435) is the most common dominantly inherited colorectal cancer syndrome with an estimated prevalence of 1:270 individuals. It increases the lifetime risk of colorectal and endometrial cancer primarily, but it is associated with a high risk of other cancers (pancreas, stomach, ovarian, central nervous system, skin, among others). It is caused by a germline mutation in one of four DNA mismatch repair genes or a terminal deletion of the MSH2-adjacent gene EpCAM.\n\nDespite adherence to cancer surveillance programs, many patients still develop colorectal cancer and endometrial cancer. The Prospective Lynch Syndrome Database (PLSD) suggests that more frequent surveillance intervals do not significantly improve cancer risk reduction. The PLSD also revealed that the incidence of colorectal cancer in MLH1 and MSH2 carriers was even higher than previously expected, reaching as high as 41-36% among MLH1 carriers, regardless of ethnic background. The development of colorectal cancer despite surveillance is an unresolved question. Therefore, there is an unmet need for effective cancer prevention strategies.",[53,54,55,56,26,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73],"Lynch Syndrome","Lynch Syndrome I","Lynch Syndrome II","Lynch Syndrome I (Site-specific Colonic Cancer)","HNPCC Gene Mutation","Hereditary Cancer Syndrome","Hereditary Cancer","MLH1 Gene Mutation","MLH1 Gene Deletion+Duplication","MLH1 Loss of Expression","MLH1 Gene Inactivation","MSH2 Gene Mutation","MSH2 Gene Deletion+Duplication","MSH2 Loss of Expression","MSH2 Gene Inactivation","MSH6 Gene Mutation","MSH6 Loss of Expression","MSH6 Gene Inactivation","PMS2 Gene Mutation","PMS2 Gene Inactivation","PMS2 Loss of Expression",[75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93],"Colorectal cancer","Endometrial cancer","Lynch syndrome-associated cancer","Surveillance","Cancer surveillance","Immune profile","Immune escape","Mismatch repair deficiency","Microbiota","Liquid biopsy","MicroRNA","Transcriptomic","Frame shift peptides","MLH1","MSH2","EpCAM","MSH6","PMS2","Hair matrix","RECRUITING","2026-04-21",{"date":97,"type":31},"2026-04-24",{"date":99,"type":31},"2023-06-01",{"date":101,"type":20},"2034-06-01",{"name":103,"class":38},"San Raffaele University",5]