{"entity":{"id":"nct04443543","kind":"trial","name":"An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of fOLFIRI (5-FU, leucovorin, irinotecan), fOLFOX (5-FU, leucovorin, oxaliplatin) and tislelizumab in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT04443543 by Fudan University, with a registry enrolment figure of 222 participants, started 2020-06-22 and due to reach its primary completion in 2026-06-30. Interventions recorded: Capecitabine (Xeloda) Pharmacogenetic Test Reagents; irinotecan; IMRT; Oxaliplatin; 5Fluorouracil; Tislelizumab. Conditions listed: Rectal Cancer. Primary outcome: clinical complete response rate. Colorectal eligibility wording from the registry: \"* difficult to achieve complete response assessed by current evidence: the maximal diameter of tumor \\>10cm; the maximal diameter of lateral lymph node \\>2cm; baseline CEA\\>=100; biopsy pathology confirmed signet ring cell carcinoma components; digital rectal examination found that the tumor is peri\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04443543","url":"https://clinicaltrials.gov/study/NCT04443543"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfiri","folfox","tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04443543","phase":"2","setting":"Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Chemoradiotherapy: A Multi-centre, Adaptive-design, Phase II Prospective Cohort Study","sponsor":"Fudan University","participation":[{"nct":"NCT04443543","source":"https://clinicaltrials.gov/study/NCT04443543","fetchedAt":"2026-10-07T16:53:20.581Z","studySha256":"e6220ab242ec29ace0fbfe98b6d62c3085fed74834d8b75b9a75a7df174a64d1","overallStatus":"NOT_YET_RECRUITING","lastUpdatePosted":"2020-06-30","leadSponsor":"Fudan University","collaboratorCount":0,"minimumAge":"18 Years","maximumAge":"75 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":222,"enrolmentType":"ESTIMATED","siteCount":1,"recruitingSiteCount":0,"countries":["China"]}],"started":"2020-06-22","startedType":"estimated","enrolled":222,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04443543/","neighbours":{"cancer":[{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"drug":[{"id":"folfiri","kind":"drug","name":"FOLFIRI (5-FU, leucovorin, irinotecan)","route":"/drugs/folfiri/"},{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"},{"id":"tislelizumab","kind":"drug","name":"Tislelizumab","route":"/drugs/tislelizumab/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}