[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627400":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":41,"locations":47,"responsibleParty":65,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"2 Gy LDRT + Pucotenlimab + CAPEOX","EXPERIMENTAL","Neoadjuvant low-dose radiotherapy (2 Gy) followed by pucotenlimab 200 mg IV Q3W plus CAPEOX chemotherapy.",[13,14,15],"Radiation: Low-dose radiotherapy","Drug: Pucotenlimab","Drug: CAPEOX\u002FXELOX",{"label":17,"type":10,"description":18,"interventionNames":19},"5 Gy LDRT + Pucotenlimab + CAPEOX","Neoadjuvant low-dose radiotherapy (5 Gy) followed by pucotenlimab 200 mg IV Q3W plus CAPEOX chemotherapy.",[13,14,15],[21,27,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Low-dose radiotherapy","Low-dose radiotherapy delivered by linear accelerator to the primary rectal tumor and regional lymphatic drainage areas using IMRT or 3D-CRT techniques. Participants receive either 2 Gy or 5 Gy according to randomized assignment, administered prior to initiation of systemic neoadjuvant therapy.",[9,17],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Pucotenlimab","Pucotenlimab is a programmed cell death protein 1 (PD-1) monoclonal antibody. It is administered at a fixed dose of 200 mg by intravenous infusion on Day 2 of each 21-day cycle, every 3 weeks (Q3W), during the neoadjuvant treatment phase.",[9,17],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"CAPEOX\u002FXELOX","CAPEOX chemotherapy consists of oxaliplatin 130 mg\u002Fm² administered intravenously on Day 1 and capecitabine 1000-1250 mg\u002Fm² administered orally twice daily on Days 1-14 of each 21-day cycle during neoadjuvant therapy.",[9,17],[37],{"name":38,"affiliation":39,"role":40},"Pei-Rong Ding","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":26,"email":46},"Wu Jiang","CONTACT","+86-15989120166","jiangwu@sysucc.org.cn",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Dept. of Colorectal Surgery, Sun Yat-sen University Cancer Center. Yuexiu District, Dongfeng East Road 651","RECRUITING","Guangzhou","Guanggong","510060","China","CN",{"type":57,"coordinates":58},"Point",[59,60],113.25,23.11667,{"lat":60,"lon":59},[63,64],{"name":43,"role":44,"phone":45,"phoneExt":26,"email":46},{"name":38,"role":40,"phone":26,"phoneExt":26,"email":26},{"type":40,"investigatorFullName":38,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Director of the Department of Colorectal Surgery","100627400","phase-2-low-dose-radiotherapy-to-sensitize-pucotenlimab-plus-capeox-for-pmmr-locally-advanced-rectal-cancer-100627400",false,"NCT07448142","Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer","A Randomized, Two-Arm, Open-Label Phase II Trial of Low-Dose Radiotherapy Sensitization Combined With Pucotenlimab and CAPEOX as Neoadjuvant Therapy for pMMR\u002FMSS Locally Advanced Rectal Adenocarcinoma","Inclusion Criteria\n\n* Written informed consent provided prior to any study-specific procedures.\n* Age 18 to 75 years at the time of enrollment.\n* Histologically confirmed rectal adenocarcinoma.\n* Tumor located within 10 cm from the anal verge, as assessed by endoscopy or imaging.\n* Locally advanced disease, defined as clinical stage T2N+ or T3-T4a (any N) based on pelvic magnetic resonance imaging (MRI).\n* Proficient mismatch repair (pMMR) or microsatellite-stable (MSS) tumor status confirmed by immunohistochemistry or molecular testing.\n* No evidence of distant metastasis on preoperative imaging, including chest, abdominal, and pelvic computed tomography (CT).\n* Circumferential resection margin (CRM) ≥2 mm and no involvement of the mesorectal fascia on baseline MRI.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Adequate organ function as defined by:\n* Absolute neutrophil count ≥1.5 × 10⁹\u002FL\n* Platelet count ≥100 × 10⁹\u002FL\n* Hemoglobin ≥90 g\u002FL\n* Total bilirubin ≤1.5 × upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN\n* Creatinine clearance ≥50 mL\u002Fmin\n* Thyroid-stimulating hormone (TSH) within normal limits\n* Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a protocol-defined period after the last dose.\n* Men with partners of childbearing potential must agree to use effective contraception during the study and for a protocol-defined period after the last dose.\n\nExclusion Criteria\n\n* Clinical T4b disease, defined as tumor invasion into adjacent organs or structures on baseline imaging.\n* Circumferential resection margin (CRM) \\\u003C2 mm or definite involvement of the mesorectal fascia on baseline MRI.\n* Evidence of distant metastasis outside the pelvis.\n* Prior pelvic or abdominal radiotherapy.\n* Prior treatment with immune checkpoint inhibitors or other systemic anticancer therapy for rectal cancer.\n* Active or history of autoimmune disease requiring systemic treatment, except for conditions considered low risk for recurrence (e.g., vitiligo, resolved childhood asthma).\n* Ongoing use of systemic immunosuppressive therapy, including corticosteroids equivalent to \\>10 mg\u002Fday of prednisone, within 2 weeks prior to enrollment.\n* Known human immunodeficiency virus (HIV) infection.\n* Active hepatitis B virus infection with positive hepatitis B surface antigen and high viral load, or hepatitis C virus infection requiring treatment.\n* Uncontrolled active infection or other serious medical condition that, in the investigator's judgment, would compromise patient safety or study compliance.\n* History of another malignancy within 5 years, except for adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies with negligible risk of recurrence.\n* Known hypersensitivity or allergy to pucotenlimab, oxaliplatin, capecitabine, or any of their excipients.\n* Pregnant or breastfeeding women.\n* Any condition that, in the investigator's opinion, makes the participant unsuitable for study participation.","ALL","18 Years","75 Years",{"count":78,"type":79},50,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","This is a prospective, open-label, randomized, parallel-group phase II trial evaluating the efficacy and safety of a low-dose radiotherapy sensitization strategy combined with a PD-1 antibody (pucotenlimab) and CAPEOX as neoadjuvant therapy in patients with pMMR\u002FMSS locally advanced rectal adenocarcinoma. Participants will be randomized 1:1 to receive either 2 Gy or 5 Gy low-dose radiotherapy. Low-dose radiotherapy is delivered as a single fraction of 2 Gy (Arm A) or 5 Gy (Arm B). On the day after radiotherapy, participants will start pucotenlimab 200 mg IV Q3W (administered on Day 2 of each 21-day cycle) plus CAPEOX chemotherapy. Early response will be assessed after 2 cycles using endoscopy and pelvic MRI to guide subsequent treatment: participants with partial response may discontinue radiotherapy and continue neoadjuvant systemic therapy; participants with stable disease may switch to standard chemoradiotherapy; participants with progressive disease will receive multidisciplinary-team-guided salvage therapy. After 4 cycles, participants with clinical complete response may adopt a watch-and-wait strategy; otherwise, they will undergo radical surgery 2-4 weeks after completion of neoadjuvant therapy. Long-term follow-up will include recurrence and survival outcomes and quality of life.",[85],"Colorectal Cancer (CRC)",[87,88,23,89,29,90,91,92,93,94,95],"Colorectal cancer","Neoadjuvant therapy","Immunotherapy","CAPEOX","Total neoadjuvant therapy","Organ preservation","Complete Response Rate","Disease-free survival","Overall survival","2026-05-01",{"date":98,"type":99},"2026-05-07","ACTUAL",{"date":101,"type":99},"2026-03-15",{"date":103,"type":79},"2032-09-01",{"name":5,"class":6},1]