[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mss-microsatellite-stable\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mss-microsatellite-stable":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100635345","phase-3-scrt-based-itnt-vs-lcrt-based-tnt-for-mss-locally-advanced-rectal-cancer-100635345",false,"NCT07551479","SCRT Based iTNT vs. LCRT Based TNT for MSS Locally Advanced Rectal Cancer","SCRT Followed by CAPOX and PD-1 Inhibitor Versus LCCRT Followed by CAPOX in Total Neoadjuvant Treatment for High-risk LARC: A Prospective, Randomized, Multicenter, Phase III Study","TORCH-STAR","Inclusion Criteria\n\n1. Age 18-75 years old, female and male;\n2. Pathological confirmed adenocarcinoma;\n3. The distance from anal verge ≤ 10 cm;\n4. MSI\u002FMMR status: MSS\u002FpMMR;\n5. Clinical stage T3-4 and\u002For N+, without distance metastases;\n6. At least one of the following factors is present: distance from the anus ≤5 cm, cT4, cN2, positive cMRF, positive cEMVI, positive tumor deposit or positive lateral lymph node;\n7. KPS ≥ 70;\n8. No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;\n9. Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10\\^9\u002FL, Hb ≥ 90 g\u002FL, PLT ≥ 100 × 10\\^9\u002FL, ALT\u002F AST ≤ 2.5 ULN, Cr ≤ 1 ULN;\n10. With good compliance and signed the consent form.\n\nExclusion Criteria\n\n1. Pregnancy or breast-feeding women;\n2. Known history of other malignancies within 5 years;\n3. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);\n4. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;\n5. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;\n6. Uncontrolled infection which needs systemic therapy;\n7. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;\n8. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection;\n9. Allergic to any component of the therapy.","ALL","18 Years","75 Years",{"count":21,"type":22},612,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","In this prospective, multicentre, randomized phase III trial, 612 locally advanced rectal cancer (LARC, T3-4\u002FN+M0) patients with at least one high-risk features (lower location (≤5cm), cT4, cN2, MRF+, EMVI+, TD+) will be included, and randomly assigned to TNT group and iTNT group (1:1). TNT group receives long-course chemoradiotherapy (50Gy\u002F25Fx concurrent with oral capecitabine) followed by 6 cycles of CAPOX. iTNT group receives short-course radiotherapy (25Gy\u002F5Fx) followed by 6 cycles of Serplulimab combined with CAPOX. After the efficacy evaluation, the patients who achieves clinical complete response (cCR) will be managed by a watch and wait (W\\&W) protocol and non-cCR patients will be recommended surgery. The primary endpoint is 3-year event-free survival rate (3yEFS%). The secondary endpoints include the complete response (CR, pathological complete response \\[pCR\\] plus cCR) rate, 3-year organ preservation rate, 3-year disease-free survival rate (3yDFS%), 3-year local recurrence free survival rate (3yLRFS%), 3-year distant metastasis free survival rate (3yDMFS%), 3-year overall survival rate (3yOS%), grade 3-4 acute adverse effects (AE) rate, rate of surgical complications, anal functions and quality of life, etc.",[28,29],"Locally Advanced Rectal Cancer (LARC)","MSS (Microsatellite Stable)",[31,32,33,34,35],"Total Neoadjuvant Therapy","Immunotherapy","Survival Rate","Organ preservation","Locally advanced rectal cancer","NOT_YET_RECRUITING","2026-04-22",{"date":39,"type":40},"2026-04-24","ACTUAL",{"date":42,"type":22},"2026-05-01",{"date":44,"type":22},"2035-12-31",{"name":46,"class":47},"Fudan University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100631855","phase-2-a-phase-ii-study-of-sintilimab-combined-with-ipilimumab-n01-cetuximab-and-dabrafenib-in-patients-with-microsatellite-stable-braf-v600e-mutated-metastatic-colorectal-cancer-100631855","NCT07506109","A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Provided written informed consent.\n2. Age ≥ 18 years.\n3. Histologically or pathologically confirmed colorectal adenocarcinoma.\n4. Documented microsatellite stable (MSS) and BRAF V600E mutation by prior genomic testing.\n5. Locally advanced unresectable disease or distant metastasis.\n6. No prior treatment with BRAF\u002FMEK\u002FERK inhibitors, EGFR inhibitors, or immune checkpoint inhibitors (ICI).\n7. Presence of measurable target lesions per RECIST 1.1.\n8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.\n9. Adequate organ function, based on the following laboratory values obtained within 7 days prior to Cycle 1 Day 1:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL.\n   2. Absolute neutrophil count ≥ 1,500\u002Fmm³ (≥ 1.5 × 109\u002FL).\n   3. Platelet count ≥ 80,000\u002Fmm³ (≥ 80 × 109\u002FL).\n   4. Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN).\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n   6. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin.\n10. Willing and able to comply with study procedures and visit schedule.\n\nExclusion Criteria:\n\n1. Received any approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment.\n2. Underwent any surgery or invasive procedure within 4 weeks prior to study initiation (exceptions include venous catheter placement and paracentesis\u002Fdrainage).\n3. Multiple primary malignancies (exceptions include completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or any other cancer that has been in complete remission for at least 3 years).\n4. Presence of severe comorbidities or serious medical conditions.\n5. Pregnant or breastfeeding females.\n6. The investigator deems the patient unsuitable for participation in this study.",{"count":56,"type":22},49,[58],"PHASE2","Colorectal cancer (CRC) is the second leading cause of cancer-related death globally. BRAF V600E mutations occur in approximately 12% of metastatic CRC (mCRC) patients, conferring an extremely poor prognosis with a median overall survival (OS) of only 11 months for standard chemotherapy. Most BRAF V600E-mutant mCRC are microsatellite stable (MSS) and do not benefit from single-agent PD-1\u002FPD-L1 inhibition.\n\nPreclinical and clinical evidence indicates that BRAF inhibition in combination with EGFR blockade can induce DNA damage, trigger a deficient mismatch repair (dMMR) phenotype, and increase tumor mutational burden (TMB), thereby sensitizing MSS tumors to immune checkpoint inhibition. This provides a strong rationale for combining BRAF\u002FEGFR inhibitors with anti-PD-1 and anti-CTLA-4 immunotherapy.\n\nThis is a single-arm, open-label, Phase II clinical trial. The primary objective is to evaluate the efficacy and safety of the triplet combination of sintilimab (anti-PD-1), ipilimumab N01 (anti-CTLA-4), cetuximab (anti-EGFR), and dabrafenib (BRAF inhibitor) in patients with MSS, BRAF V600E-mutant mCRC.",[61,62,63,29,64,65,66],"BRAF V600E","Colorectal Cancer","Sintilimab","Cetuximab","Dabrafenib","Ipilimumab N01","RECRUITING","2026-04-01",{"date":70,"type":40},"2026-04-07",{"date":72,"type":40},"2026-03-01",{"date":74,"type":22},"2028-06",{"name":76,"class":47},"Tianjin Medical University Cancer Institute and Hospital",4]