[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606444":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":20,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":20,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":20,"overallStatus":53,"whyStopped":20,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":20},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Short-Course Radiotherapy Followed by QL1706 Plus mFOLFOX6","EXPERIMENTAL","Participants will receive short-course radiotherapy (SCRT, 25 Gy in 5 fractions over one week) followed by total neoadjuvant therapy (TNT) consisting of QL1706 (a bifunctional MabPair antibody targeting PD-1 and CTLA-4, investigational code name only) in combination with mFOLFOX6 chemotherapy for several cycles. After completion of neoadjuvant therapy, patients will undergo total mesorectal excision (TME) when operable, or may be managed with a watch-and-wait strategy if a strict clinical complete response (cCR) is achieved per institutional criteria. Standard perioperative care and follow-up will be provided.",[13],"Drug: Drug: QL1706 Drug: mFOLFOX6 Radiation: Short-Course Radiotherapy (SCRT)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Drug: QL1706 Drug: mFOLFOX6 Radiation: Short-Course Radiotherapy (SCRT)","QL1706 is an investigational bifunctional MabPair antibody that simultaneously targets PD-1 (IgG4) and CTLA-4 (IgG1). It is administered intravenously according to the study protocol during the neoadjuvant chemotherapy cycles. The use of QL1706 aims to enhance antitumor immunity in the pMMR\u002FMSS rectal cancer setting, a population typically unresponsive to immune checkpoint blockade alone.\n\nmFOLFOX6 is a standard oxaliplatin-based chemotherapy regimen composed of oxaliplatin, leucovorin, and 5-fluorouracil. It is administered in combination with QL1706 during the neoadjuvant phase as part of total neoadjuvant therapy (TNT). The regimen is modified to optimize tolerability while maintaining efficacy in locally advanced rectal cancer.\n\nShort-course radiotherapy consists of a total dose of 25 Gy delivered in 5 fractions over one week to the pelvis. This approach is designed to rapidly downstage tumors, release tumor antigens, and prime the immune microenvironment for subsequent immunotherapy",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Zhenhai Lu, MD","CONTACT","+862087343124","luzhh@sysucc.org.cn",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":31,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Zhen-Hai Lu","Prof","Sun Yat-Sen University Cancer Center","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":43,"type":44},66,"ESTIMATED","INTERVENTIONAL",[47],"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.",[50,51,52],"Locally Advanced Rectal Cancer (LARC)","Mismatch Repair-Proficient (pMMR) Rectal Cancer","Non-metastatic Rectal Cancer","NOT_YET_RECRUITING","2025-09-09",{"date":56,"type":57},"2025-09-16","ACTUAL",{"date":59,"type":44},"2025-09-20",{"date":61,"type":44},"2029-09-20",{"name":5,"class":6}]