{"entity":{"id":"nct05794750","kind":"trial","name":"Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13）","aka":["AK104-IIT-13"],"tldr":"A phase 2 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by JIN JING, not yet recruiting.","summary":"Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13） is a phase 2, interventional study registered as NCT05794750 by JIN JING, with a registry enrolment figure of 50 participants, started 2023-04-24 and due to reach its primary completion in 2027-04-24. Interventions recorded: AK104 injection; TME surgery; Capecitabine; Oxaliplatin. Conditions listed: Locally Advanced Rectal Cancer. Primary outcome: Pathologic complete response rate (pCR). Colorectal eligibility wording from the registry: \"Fiber colonoscopy or diagnosis examination, the lower boundary of the lesion is 15m ≤ from the margin;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05794750","url":"https://clinicaltrials.gov/study/NCT05794750"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05794750","phase":"2","setting":"A Single-arm, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Preoperative Short-course Radiotherapy Followed by Sequential Chemotherapy and AK104 for Locally Advanced Rectal Cancer","sponsor":"JIN JING","enrolled":50,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05794750/","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":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}