[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-rectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-rectal-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100573831","phase-2-preoperative-chemoradiotherapy-and-toripalimab-in-locally-recurrent-rectal-cancer-100573831",false,"NCT06751394","Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer","Preoperative Treatment with Radiotherapy and Anti-PD1 for Resectable Recurrent Rectal Cancer (TRACER)","TRACER","Inclusion Criteria:\n\n1. Patient is 18-75 years old at the time of signing the informed consent form.\n2. ECOG performance status 0-1.\n3. Pathological confirmed or MRI\u002F enhanced CT confirmed pelvic recurrence.\n4. No distant metastasis lesions outside the pelvic.\n5. No prior radiotherapy within 6 months.\n6. Participants with pelvic recurrence who have not previously been treated with first-line chemotherapy.\n7. Life expectancy at least 24 weeks.\n8. 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.\n9. Non pregnancy or lactation.\n10. Fully informed and willing to provide written informed consent for the trial.\n\nExclusion Criteria:\n\n1. Neutrophil \\\u003C 1.5×10\\^9\u002FL, PLT \\\u003C 75×10\\^9\u002FL.\n2. TBIL \\> 1.5 ULN.\n3. AST or ALT \\> 2.5 ULN, or ALT and \u002F or AST \\> 5 ULN in patients with liver metastasis.\n4. Cr \\> 1.5 ULN.\n5. Serious electrolyte abnormalities.\n6. Active coronary artery disease, severe\u002Funstable angina, or newly diagnosed angina or myocardial infarction within 12 months.\n7. Arterial thrombosis or deep vein thrombosis within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, deep vein thrombosis.\n8. Congestive cardiac failure ≥ NYHA grade 2.\n9. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B defined as HBV-DNA ≥ 500 IU\u002Fml; hepatitis C defined as HCV-RNA higher than lower limit of detection) or hepatitis B and hepatitis C virus co-infection.\n10. Active inflammatory bowel disease or other colorectal diseases that lead to chronic diarrhea.\n11. Suspected autoimmune disease.\n12. Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia).\n13. Suspected allergic to any drugs used in the trial.\n14. History of any immune checkpoint inhibitor therapy.\n15. Clinically detectable second primary malignancy, or history of other malignancies within 5 years.\n16. 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.\n17. 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.\n18. Serious mental abnormalities.","ALL","18 Years","75 Years",{"count":21,"type":22},44,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The study is a prospective, single-center, single-arm, phase II clinical trial. Patients with pelvic recurrent rectal cancer aged from 18 to 75 years, Eastern Cooperative Oncology Group performance status of 0-1, will receive 45-50Gy\u002F25Fx irradiation or 30Gy\u002F15Fx reirradiation (history of pelvic radiation). PD-1 inhibitor (Toripalimab) was used throughout the course of induction chemotherapy (before radiation), concurrent chemoradiation and consolidation chemotherapy (after radiation); radical resection was followed by well-experienced surgeons .\n\nThe primary endpoint was pathological complete response (pCR) rate. Secondary endpoints were R0 resection rate, 3-year progression-free survival, overall survival, pathological tumor regression grade, operation characteristics and incidence of major surgical complications.",[28],"Recurrent Rectal Cancer",[30],"locally recurrent rectal cancer; PD-1 inhibitor; preoperative chemoradiotherapy","NOT_YET_RECRUITING","2024-12-24",{"date":34,"type":35},"2024-12-27","ACTUAL",{"date":37,"type":22},"2025-01-01",{"date":39,"type":22},"2028-12-31",{"name":41,"class":42},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":43},"100487511","phase-2-the-combination-of-hypofractionated-radiotherapy-and-immunotherapy-in-locally-recurrent-rectal-cancer-100487511","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.",{"count":53,"type":22},93,[25],"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.",[28],"RECRUITING","2024-09-28",{"date":60,"type":35},"2024-10-01",{"date":62,"type":35},"2022-11-30",{"date":64,"type":22},"2025-12-01",{"name":66,"class":42},"Fudan University",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100392368","phase-3-induction-chemotherapy-for-locally-recurrent-rectal-cancer-100392368","NCT04389086","Induction Chemotherapy for Locally Recurrent Rectal Cancer","Multicentre, Open-label, Randomised, Controlled, Parallel Arms Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy Alone as Neoadjuvant Treatment for Locally Recurrent Rectal Cancer - PelvEx II","PelvEx II","Inclusion Criteria:\n\n* 18 years or older\n* Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal or distal sigmoidal cancer either by histopathology ór clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT)\n* Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy.\n* WHO performance score 0-1\n* Written informed consent\n\nExclusion Criteria:\n\n* Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation.\n* Known homozygous DPD deficiency\n* Any chemotherapy in the past 6 months.\n* Any contraindication for the planned chemotherapy, as determined by the medical oncologist.\n* Radiotherapy in the past 6 months for primary rectal cancer.\n* Any contraindication for the planned chemoradiotherapy, as determined by the medical oncologist and\u002For radiation oncologist.\n* Any contraindication for surgery, as determined by the surgeon and\u002For anaesthesiologist.\n* Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC.",{"count":76,"type":22},364,[78],"PHASE3","This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)",[28],[82,83,84,85],"Locally recurrent rectal cancer","Neoadjuvant therapy","Induction chemotherapy","Resection margin","2022-09-01",{"date":88,"type":35},"2022-09-06",{"date":90,"type":35},"2020-11-13",{"date":92,"type":22},"2030-03-01",{"name":94,"class":42},"Catharina Ziekenhuis Eindhoven",14]