[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487511":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":71,"centralContacts":75,"locations":80,"responsibleParty":98,"collaborators":41,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":41,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":41,"overallStatus":83,"whyStopped":41,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment arm","EXPERIMENTAL","The enrolled patients will receive 25-40Gy\u002F5Fx irradiation or 15-30Gy\u002F5Fx reirradiation (pelvic radiation history) for pelvic recurrence.\n\nCohort A patients will receive CAPOX, FOLFIRI or mFOLFOX6 chemotherapy andcohort B patients will receive CAPOX, FOLFIRI, mFOLFOX6, mXELIRI, irinotecan and raltitrexed, or oxaliplatin and raltitrexed chemotherapy, based on previous chemotherapy and adverse reactions to chemotherapy agents or at the discretion of the oncologist.\n\nAll metastasis sites will receive stereotactic ablative radiotherapy (SABR) between chemoimmunotherapy cycles. Five-fraction regimens (25-50Gy\u002F5Fx) are delivered daily. Dose Constraints are based on SABR-COMET 10 trial.\n\nBesides, according to the medical oncologist recommendation, patients with unresectable pelvic recurrence or distant metastasis will receive target therapy based on the KRAS\u002FNRAS\u002FBRAF mutation station.",[13,14,15,16,17,18,19,20,21,22],"Drug: PD-1 antibody","Drug: Capecitabine","Drug: 5FU","Drug: folinic acid","Drug: Oxaliplatin","Drug: Irinotecan","Drug: Raltitrexed","Drug: Cetuximab","Drug: Bevacizumab","Radiation: Radiation",[24,31,37,42,46,50,54,58,62,66],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","PD-1 antibody","PD-1 antibody (Toripalimab): 240mg q3w or 160mg q2w",[9],[30],"Toripalimab",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Capecitabine","Capecitabine: 1000mg\u002Fm2 d1-14 q3w",[9],[36],"Xeloda",{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"5FU","400 mg\u002Fm2 (bolus) and 2400 mg\u002Fm2 (continuous infusion for 48hr)",[9],null,{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"folinic acid","400 mg\u002Fm2 q2w",[9],{"type":25,"name":47,"description":48,"armGroupLabels":49,"otherNames":41},"Oxaliplatin","130 mg\u002Fm² q3w or 85 mg\u002Fm² q2w",[9],{"type":25,"name":51,"description":52,"armGroupLabels":53,"otherNames":41},"Irinotecan","180 mg\u002Fm² q2w and 200 mg\u002Fm² q3w",[9],{"type":25,"name":55,"description":56,"armGroupLabels":57,"otherNames":41},"Raltitrexed","2 mg\u002Fm² q2w and 3 mg\u002Fm² q3w",[9],{"type":25,"name":59,"description":60,"armGroupLabels":61,"otherNames":41},"Cetuximab","400 mg\u002Fm² q2w",[9],{"type":25,"name":63,"description":64,"armGroupLabels":65,"otherNames":41},"Bevacizumab","5 mg\u002Fkg q2w or 7.5mg\u002Fkg q3w",[9],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":41},"RADIATION","Radiation","25-40Gy\u002F5Fx irradiation or 15-30Gy\u002F5Fx reirradiation (pelvic radiation history) for pelvic recurrence tumor.\n\n35-60Gy\u002F5-8Fx irradiation for distance metastasis tumor.",[9],[72],{"name":73,"affiliation":5,"role":74},"Zhen Zhang, MD PhD","PRINCIPAL_INVESTIGATOR",[76],{"name":73,"role":77,"phone":78,"phoneExt":41,"email":79},"CONTACT","18801735029","zhen_zhang@fudan.edu.cn",[81],{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":90,"coordinates":91},"Point",[92,93],121.45806,31.22222,{"lat":93,"lon":92},[96],{"name":97,"role":77,"phone":78,"phoneExt":41,"email":79},"Zhen Zhang, MD,PhD",{"type":74,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Zhen Zhang","Professor","100487511","phase-2-the-combination-of-hypofractionated-radiotherapy-and-immunotherapy-in-locally-recurrent-rectal-cancer-100487511",false,"NCT05628038","The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer","Hypofractionated Radiotherapy Combined With Toripalimab and Chemotherapy +\u002F- Target Therapy for Locally Recurrent Rectal Cancer: a Single-arm, Two-cohort, Phase II Trial (TORCH-R)","TORCH-R","Inclusion Criteria:\n\n* Patient is 18-75 years old at the time of signing the informed consent form.\n* ECOG performance status 0-1.\n* MRI\u002Fenhanced CT confirmed pelvic recurrence. According to RECIST 1.1, there is at least one measurable pelvic lesion.\n* Distant metastasis lesions are no more than 5 and metastatic organ are no more than 3.\n* No prior radiotherapy within 6 month.\n* Previous system therapy. Patients Group Cohort A: participants with pelvic recurrence who have not previously been treated with first-line chemotherapy. Cohort B: Patients with disease progression or new lesions after first-line chemotherapy.\n* Has an investigator determined life expectancy of at least 24 weeks.\n* Demonstrate adequate organ function (bone marrow, liver, kidney and clotting function) within 7 days before the first administration without using blood products or hematopoietic stimulating factors.\n* Non pregnant or lactating patients. Effective contraceptive methods should be used during the study and within 6 months of the last administration.\n* Fully informed and willing to provide written informed consent for the trial.\n\nExclusion Criteria:\n\n* Neutrophil \\\u003C 1.5×10\\^9\u002FL, PLT \\\u003C 100×10\\^9\u002FL (PLT \\\u003C 80×10\\^9\u002FL in patients with liver metastasis), or Hb \\\u003C 90g\u002FL; blood transfusion within 2 weeks before enrollment is not allowed to meet the enrollment criteria.\n* TBIL \\> 1.5 ULN, or TBIL \\> 2.5 ULN in patients with liver metastasis.\n* AST or ALT \\> 2.5 ULN, or ALT and \u002F or AST \\> 5 ULN in patients with liver metastasis.\n* Cr \\> 1.5 ULN, or creatinine clearance \\\u003C 50ml \u002F min (calculated according to Cockcroft Gault formula).\n* APTT \\> 1.5 ULN, PT \\> 1.5 ULN (subject to the normal value of the clinical trial research center).\n* Serious electrolyte abnormalities.\n* Urinary protein ≥ 2+, or 24-hour urine protein ≥1.0g\u002F24h.\n* Uncontrolled hypertension: SBP \\>140mmHg or DBP \\> 90mmHg.\n* The presence of gastrointestinal diseases such as gastric or duodenal active ulcers, ulcerative colitis or unresected tumours with active bleeding; or other conditions likely to cause gastrointestinal bleeding or perforation; or unhealed gastrointestinal perforation or gastrointestinal fistula after surgical treatment.\n* A history of arterial thrombosis or deep vein thrombosis within 6 months; a history of bleeding or evidence of bleeding tendency within 2 months.\n* A history of heart disease within 6 months (including congestive heart failure, acute myocardial infarction, severe\u002Funstable angina, coronary artery bypass grafting, cardiac insufficiency ≥ NYHA grade 2 and LVEF\\\u003C50%).\n* Uncontrolled malignant pleural effusion, ascites, or pericardial effusion.\n* History of anti-PD-1, PD-L1, PD-L2, CTLA-4 or any other specific T cell co-stimulation or checkpoint pathway targeted therapy.\n* The presence of a clinically detectable second primary malignancy, or history of other malignancies within 5 years excluding adequately treated non-melanoma skin cancer, carcinoma in situ of cervix and superficial bladder tumour (non-invasive tumour, or carcinoma in situ, or T1).\n* A history of liver disease including, but not limited to HBV infection or HBV DNA positive(≥1×10\\^4\u002Fml), HCV infection or HCV DNA positive(≥1×10\\^3\u002Fml) and liver cirrhosis.\n* Pregnant or lactating women or women who may be pregnant have a positive pregnancy test before the first medication; Or the female participants themselves and their partners who were unwilling to implement strict contraception during the study period.\n* The investigator considers that the subject is not suitable to participate in this clinical study due to any clinical or laboratory abnormalities or compliance problems.\n* Serious mental abnormalities.\n* The diameter of brain metastasis is greater than 3cm or the total volume is greater than 30cc.\n* Clinical or radiological evidence of spinal cord compression, or tumours within 3 mm of the spinal cord on MRI.","ALL","18 Years","75 Years",{"count":113,"type":114},93,"ESTIMATED","INTERVENTIONAL",[117],"PHASE2","The study is a prospective, single-center, single-arm, two-cohort, phase II clinical trial. Patients aged 18 years or older who had pelvic recurrence rectal cancer with or without resectable distant metastasis, with treatment naive disease (cohort A) or progressive disease after first-line chemotherapy (cohort B), Eastern Cooperative Oncology Group performance status of 0-1, will receive 25-40Gy\u002F5Fx irradiation or 15-30Gy\u002F5Fx reirradiation (pelvic radiation history), 18 weeks toripalimab and investigator's choice of chemotherapy +\u002F- target therapy, and stereotactic ablative radiotherapy (SABR) for all metastatic lesions between chemoimmunotherapy cycles, followed by multidisciplinary team (MDT) for decision:follow-up of complete response (CR), radical surgery, sustained treatment of non resection, or exit.\n\nThe primary endpoint was local objective response rate. Secondary endpoints were extrapelvic objective response rate, R0 resection rate, duration of response, progression-free survival, overall survival, and safety and tolerability of the treatment.\n\nShanghai Junshi Biomedical Technology Co., Ltd. Provides the first three cycles of toripalimab for free and has purchased liability insurance for clinical trial subjects.",[120],"Recurrent Rectal Cancer","2024-09-28",{"date":123,"type":124},"2024-10-01","ACTUAL",{"date":126,"type":124},"2022-11-30",{"date":128,"type":114},"2025-12-01",{"name":5,"class":6},1]