[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601652":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":63,"centralContacts":67,"locations":74,"responsibleParty":91,"collaborators":41,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":41,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":41,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":41,"overallStatus":76,"whyStopped":41,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",[8,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: SCRT + iTNT","EXPERIMENTAL","Group A: SCRT + iTNT\n\nRadiotherapy (SCRT): Total dose 25 Gy delivered in 5 fractions (5 Gy per fraction, once daily over 5 consecutive days).\n\nImmunotherapy (HLX10): 300 mg via intravenous infusion every 3 weeks (q3w) for 6 cycles, initiated 1 week after radiotherapy completion.\n\nChemotherapy (CAPEOX regimen):\n\nOxaliplatin: 130 mg\u002Fm² IV infusion over 120 minutes on Day 1.\n\nCapecitabine: 1000 mg\u002Fm² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14.\n\nCycle duration: 3 weeks per cycle; total of 6 cycles during the neoadjuvant phase.\n\nThen followed by a total mesorectal excision(TME) or Watch \\& Wait strategy for clinical complete remission voluntary patients.",[13,14,15,16,17],"Radiation: Short-course radiotherapy","Drug: Capecitabine","Drug: Oxaliplatin","Drug: HLX10","Procedure: TME surgery",{"label":19,"type":10,"description":20,"interventionNames":21},"Group B: LCRT + iTNT","Group B: LCRT + iTNT\n\nRadiotherapy with Concurrent Chemotherapy (LCRT):\n\nTotal dose 50.4 Gy delivered in 28 fractions (1.8 Gy per fraction, once daily, 5 days per week).\n\nConcurrent Capecitabine: 825 mg\u002Fm² orally twice daily, 5 days per week (administered on radiotherapy days).\n\nImmunotherapy (HLX10): 300 mg IV infusion q3w for 6 cycles, initiated 2 weeks after radiotherapy completion.\n\nChemotherapy (CAPEOX regimen):\n\nOxaliplatin: 130 mg\u002Fm² IV infusion over 120 minutes on Day 1.\n\nCapecitabine: 1000 mg\u002Fm² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14.\n\nCycle duration: 3 weeks per cycle; initiated 2 weeks post-radiotherapy; total of 6 cycles during the neoadjuvant phase.\n\nThen followed by a total mesorectal excision(TME) or Watch \\& Wait strategy for clinical complete remission voluntary patients.",[22,14,15,16,17],"Radiation: Long-course radiotherapy",{"label":24,"type":25,"description":26,"interventionNames":27},"Group C: LCRT + TNT","ACTIVE_COMPARATOR","Group C: LCRT + TNT\n\nRadiotherapy with Concurrent Chemotherapy (LCRT):\n\nTotal dose 50.4 Gy delivered in 28 fractions (1.8 Gy per fraction, once daily, 5 days per week).\n\nConcurrent Capecitabine: 825 mg\u002Fm² orally twice daily, 5 days per week (administered on radiotherapy days).\n\nTNT Chemotherapy (CAPEOX regimen) with immunotherapy placebo:\n\nHLX10 placebo: 300 mg IV infusion q3w for 6 cycles, initiated 2 weeks after radiotherapy completion.\n\nOxaliplatin: 130 mg\u002Fm² IV infusion over 120 minutes on Day 1.\n\nCapecitabine: 1000 mg\u002Fm² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14.\n\nCycle duration: 3 weeks per cycle; initiated 2 weeks post-radiotherapy; total of 6 cycles during the neoadjuvant phase.\n\nThen followed by a total mesorectal excision(TME) or Watch \\& Wait strategy for clinical complete remission voluntary patients.",[22,14,15,17,28],"Drug: HLX10 placebo",[30,37,42,47,51,55,60],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"RADIATION","Short-course radiotherapy","Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy.",[9],[36],"SCRT",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Long-course radiotherapy","Long-course radiotherapy (LCRT, 50.4 Gy administered in 28 fractions) will be delivered concurrently with oral capecitabine.",[19,24],null,{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":41},"DRUG","Capecitabine","1000mg\u002Fm2, bid, po, d1-14,q3w",[9,19,24],{"type":43,"name":48,"description":49,"armGroupLabels":50,"otherNames":41},"Oxaliplatin","130mg\u002Fm2, ivgtt, d1,q3w",[9,19,24],{"type":43,"name":52,"description":53,"armGroupLabels":54,"otherNames":41},"HLX10","300mg, ivgtt, q3w",[9,19],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":41},"PROCEDURE","TME surgery","The surgery was performed 1 week after the end of neoadjuvant therapy.",[9,19,24],{"type":43,"name":61,"description":53,"armGroupLabels":62,"otherNames":41},"HLX10 placebo",[24],[64],{"name":65,"affiliation":5,"role":66},"Zhenyu Lin, MD","PRINCIPAL_INVESTIGATOR",[68,72],{"name":65,"role":69,"phone":70,"phoneExt":41,"email":71},"CONTACT","027-85871982","whxhlzy@hust.edu.cn",{"name":73,"role":69,"phone":41,"phoneExt":41,"email":41},"Tao Zhang, MD",[75],{"facility":5,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"RECRUITING","Wuhan","Hubei","430022","China","CN",{"type":83,"coordinates":84},"Point",[85,86],114.26667,30.58333,{"lat":86,"lon":85},[89],{"name":73,"role":69,"phone":70,"phoneExt":41,"email":90},"1277577866@qq.com",{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Tao Zhang","MD","100601652","phase-3-a-clinical-trial-comparing-long-course-versus-short-course-radiotherapy-followed-by-immunotherapy-combined-with-total-neoadjuvant-therapy-tnt-to-long-course-radiotherapy-followed-by-tnt-in-locally-advanced-rectal-cancer-100601652",false,"NCT07113275","A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer","A National Multicenter, Randomized, Placebo-Controlled Phase III Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer","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. Histologically confirmed Locally Advanced rectal adenocarcinoma;\n4. Immunohistochemistry and\u002For genetic testing confirmed pMMR\u002FMSS;\n5. inferior margin ≤ 10 cm from the anal verge;\n6. ECOG performance status score is 0-1;\n7. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc;\n8. There was no operative contraindication;\n9. Laboratory tests were required to meet the following requirements: white blood cell (WBC) ≥ 4×109\u002FL; Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; Platelet count ≥ 100×109\u002FL; Hemoglobin ≥90 g\u002FL; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50 mL\u002Fmin; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n10. Urinary protein \\\u003C 2+ or 24-hour urinary protein excretion \\\u003C 1 g at baseline.\n\nExclusion Criteria:\n\n1. Patients with MSI-H\u002FdMMR LARC；\n2. Subjects who have previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other treatment targeting tumor immunomodulatory mechanisms;\n3. Presence of any concurrent disease, condition (including laboratory abnormality), history of substance abuse, or current evidence thereof, which, in the judgment of the Investigator, may compromise subject safety, interfere with the process of obtaining informed consent, affect subject compliance, or confound the safety assessment of the investigational product(s).","ALL","18 Years","75 Years",{"count":106,"type":107},444,"ESTIMATED","INTERVENTIONAL",[110],"PHASE3","This study is a national multicenter, prospective randomized, placebo- controlled Phase III clinical trial designed to investigate the potential therapeutic benefit of immunotherapy combined with total neoadjuvant therapy (TNT) and to compare the efficacy of different radiotherapy modalities followed by immunotherapy.",[113,114,115,116],"Rectal Cancer","Total Neoadjuvant Therapy","Radiotherapy","Immunotherapy","2026-05-10",{"date":119,"type":120},"2026-05-13","ACTUAL",{"date":122,"type":107},"2026-05-15",{"date":124,"type":107},"2028-12-31",{"name":93,"class":6},1]