[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mismatch-repair-proficient-pmmr-rectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mismatch-repair-proficient-pmmr-rectal-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100606444","phase-2-ql1706-with-short-course-radiotherapy-and-chemotherapy-for-mss-rectal-cancer-100606444",false,"NCT07175636","QL1706 With Short-Course Radiotherapy and Chemotherapy for MSS Rectal Cancer","A Multicenter, Prospective, Phase II Clinical Trial of Short-Course Radiotherapy Followed by QL1706 Plus mFOLFOX6 as Total Neoadjuvant Therapy for Patients With pMMR\u002FMSS Locally Advanced Rectal Cancer","Inclusion Criteria:\n\nAge 18-75 years, male or female.\n\nHistologically confirmed rectal adenocarcinoma.\n\nLocally advanced disease (cT3-4 and\u002For N+, M0) based on pelvic MRI and\u002For CT.\n\nTumor located within 12 cm from the anal verge.\n\nProven microsatellite stability (MSS) or proficient mismatch repair (pMMR) status.\n\nECOG performance status 0-1.\n\nAdequate organ function:\n\nAbsolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n\nPlatelet count ≥ 100 × 10⁹\u002FL\n\nHemoglobin ≥ 90 g\u002FL\n\nALT\u002FAST ≤ 2.5 × ULN\n\nTotal bilirubin ≤ 1.5 × ULN\n\nSerum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin\n\nNo prior pelvic radiotherapy, chemotherapy, immunotherapy, or targeted therapy for rectal cancer.\n\nSigned written informed consent\n\nExclusion Criteria:\n\nEvidence of distant metastasis.\n\nPrevious or concurrent malignant tumor (except cured basal cell carcinoma of skin or cervical carcinoma in situ).\n\nActive autoimmune disease requiring systemic immunosuppressive therapy.\n\nActive infection including hepatitis B, hepatitis C, HIV, or tuberculosis.\n\nKnown allergy or hypersensitivity to study drugs or excipients.\n\nUncontrolled cardiovascular disease (e.g., recent myocardial infarction, unstable angina, congestive heart failure, arrhythmia).\n\nPregnant or breastfeeding women.\n\nAny condition judged by investigators to make the patient unsuitable for the study.","ALL","18 Years","75 Years",{"count":20,"type":21},66,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multicenter, prospective, phase II study evaluating total neoadjuvant therapy (TNT) consisting of short-course radiotherapy (SCRT; 5×5 Gy) followed by QL1706 (a bifunctional MabPair antibody targeting PD-1 and CTLA-4, code name only) plus mFOLFOX6 chemotherapy in patients with locally advanced rectal cancer (LARC) with proficient mismatch repair\u002Fmicrosatellite-stable (pMMR\u002FMSS) biology. Patients with pMMR\u002FMSS disease derive limited benefit from immune checkpoint inhibition alone. Preclinical and clinical evidence suggests that SCRT and oxaliplatin-based chemotherapy can enhance antitumor immunity (e.g., antigen release, T-cell infiltration), providing a biological rationale for combining QL1706 with SCRT-primed TNT.\n\nEligible adults with cT3-4 and\u002For N+ mid-to-low rectal adenocarcinoma (without distant metastasis), confirmed pMMR\u002FMSS, and ECOG 0-1 will receive: SCRT (total 25 Gy over 5 fractions), then several cycles of QL1706 plus mFOLFOX6 as neoadjuvant systemic therapy. Definitive total mesorectal excision (TME) is planned per multidisciplinary assessment; a watch-and-wait approach may be considered for patients achieving a stringent clinical complete response per institutional criteria. Standard perioperative care and postoperative follow-up will be performed.\n\nPrimary endpoint is pathologic complete response (pCR, ypT0N0) rate at surgery. Key secondary endpoints include: clinical complete response (cCR) rate, major pathologic response rate, R0 resection rate, tumor downstaging, radiologic response, disease-free survival (DFS), overall survival (OS), organ preservation rate (for patients managed non-operatively), surgical morbidity, and safety\u002Ftolerability (CTCAE v5.0). Exploratory endpoints include correlations between efficacy and baseline clinicopathologic features; optional translational analyses may investigate immune-inflammation markers related to response and resistance.\n\nThis trial aims to determine whether SCRT-primed QL1706 plus mFOLFOX6 TNT can improve tumor eradication and organ preservation while maintaining acceptable safety in pMMR\u002FMSS LARC-a population with unmet need for effective immunotherapy-based strategies.",[27,28,29],"Locally Advanced Rectal Cancer (LARC)","Mismatch Repair-Proficient (pMMR) Rectal Cancer","Non-metastatic Rectal Cancer","NOT_YET_RECRUITING","2025-09-09",{"date":33,"type":34},"2025-09-16","ACTUAL",{"date":36,"type":21},"2025-09-20",{"date":38,"type":21},"2029-09-20",{"name":40,"class":41},"Sun Yat-sen University","OTHER"]