[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639861":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":50,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":25,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":77,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SCRT combined with Adalimumab and NALIRIFOX","EXPERIMENTAL","Adalimumab combined with NALIRIFOX for two cycles. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy\u002F5F). Consolidation: Adalimumab combined with NALIRIFOX for six cycles",[13],"Combination Product: Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX",{"label":15,"type":10,"description":16,"interventionNames":17},"LCRT combined with Adalimumab and NALIRIFOX","Adalimumab combined with NALIRIFOX for two cycles. Radiotherapy: Long-course chemoradiotherapy (LCRT) (50Gy\u002F25F, during the same period, capecitabine was 825 mg\u002Fm2, twice a day, 5 days a week). Consolidation: Adalimumab combined with NALIRIFOX for six cycles",[18],"Combination Product: Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX","Short course radiotherapy, 5 \\* 5Gy, once a day, 5Gy each time, for 5 days; Adalimumab 1200 mg , D1, q2w, 2 cycles before radiotherapy and 6 cycles after radiotherapy; NALIRIFOX: Oxaliplatin 85 mg\u002Fm2, D1; Liposomal irinotecan 60 mg\u002Fm2, D1; LV 200 mg\u002Fm2; 5-FU 2400 mg\u002Fm2, Infusion for 48 hours; Repeat every 2 weeks. 2 cycles before radiotherapy and 6 cycles after radiotherapy;",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX","Long course chemoradiotherapy,50 Gy in 25 fractions, during the same period, capecitabine was 825 mg \u002F m2, twice a day, 5 days a week; Adalimumab 1200 mg , D1, q2w, 2 cycles before radiotherapy and 6 cycles after radiotherapy; NALIRIFOX: Oxaliplatin 85 mg\u002Fm2, D1; Liposomal irinotecan 60 mg\u002Fm2, D1; LV 200 mg\u002Fm2; 5-FU 2400 mg\u002Fm2, Infusion for 48 hours; Repeat every 2 weeks. 2 cycles before radiotherapy and 6 cycles after radiotherapy;",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Chi Zhou","CONTACT","+86 20 87343920","447486353@qq.com",[37],{"facility":38,"status":25,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":25},"Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou 510060, P. R. China","Guangzhou","Guangdong","510000","China","CN",{"type":45,"coordinates":46},"Point",[47,48],113.25,23.11667,{"lat":48,"lon":47},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","ZHI-ZHONG PAN","Professor","100639861","phase-2-neoadjuvant-radiotherapy-combined-with-nalirifox-and-adebrelimab-in-pmmrmss-locally-advanced-rectal-cancer-a-prospective-randomized-phase-ii-clinical-trial-100639861",false,"NCT07622771","Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR\u002FMSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial","Inclusion Criteria:\n\n1. Patients or their family members agree to participate in the study and sign the informed consent form;\n2. Age 18-75 years, male or female;\n3. Locally advanced rectal adenocarcinoma confirmed by histopathology;\n4. Clinical stage cT3-4bN0M0 or cTxN+M0, with or without MRF positive, with or without EMVI positive, expected to R0 resection;\n5. without intestinal obstruction;\n6. ECOG PS 0-1;\n7. expect survival up to 2 years;\n8. White blood cell count \\> 3.5×109\u002FL；Platelet count ≥ 100×109\u002FL；Hemoglobin ≥ 80 g\u002FL；\n9. ALT ≤ 1.5×ULN, AST ≤ 1.5×ULN ；\n10. Serum creatinine ≤ 100μmol\u002Fl,\n\nExclusion Criteria:\n\n1. With inguinal lymph node metastasis or lateral lymph node metastasis (lymph node diameter ≥7 mm, or lymph node morphology and MRI features consistent with typical metastatic lymph nodes);\n2. Arrhythmia requiring antiarrhythmic treatment (except beta-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure exceeding NYHA Class II;\n3. Severe hypertension poorly controlled with medication;\n4. History of HIV infection, or active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 10⁴ copies\u002FmL), or hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of detection of the assay);\n5. Active pulmonary tuberculosis (TB), currently receiving anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year prior to screening;\n6. Other active clinically severe infections (NCI-CTCAE Version 5.0);\n7. Preoperative evidence of distant metastasis outside the pelvis;\n8. Cachexia or organ function decompensation.\n9. History of pelvic or abdominal radiotherapy;\n10. Multiple primary colorectal cancers;\n11. Patients with seizures requiring treatment (e.g., corticosteroids or antiepileptic therapy);\n12. History of other malignancies within 5 years, except cured cervical carcinoma in situ or basal cell carcinoma of the skin;\n13. Drug abuse, or medical, psychological, or social conditions that may interfere with the patient's participation in the study or affect the evaluation of study results;\n14. Active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enterocolitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism);\n15. Receipt of any anti-infective vaccine (e.g., influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment;\n16. Comorbidities requiring long-term treatment with immunosuppressive agents, or requiring systemic or local administration of corticosteroids at immunosuppressive doses (dose \\>10 mg\u002Fday of prednisone or other glucocorticoids with equivalent efficacy);\n17. Known or suspected hypersensitivity to the investigational drug, or to any medication administered in relation to this study;\n18. Any unstable condition that may jeopardize patient safety or compliance;\n19. Pregnant or lactating women, or women of childbearing potential not using adequate contraception;\n20. Refusal to sign the informed consent form.","ALL","18 Years","75 Years",{"count":64,"type":65},84,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","To explore the efficacy and safety of radiotherapy combined with Adebrelimab and NALIRIFOX in patients with pMMR\u002FMSS locally advanced rectal cancer",[71],"Rectal Cancers",[73,74,75,76],"radiotherapy","immunotherapy","neoadjuvant therapy","rectal cancer","NOT_YET_RECRUITING","2026-05-28",{"date":80,"type":81},"2026-06-03","ACTUAL",{"date":83,"type":65},"2026-06-01",{"date":85,"type":65},"2032-12-31",{"name":5,"class":6},1]