{"entity":{"id":"nct05571644","kind":"trial","name":"Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer","aka":["OPTICAL-2"],"tldr":"A phase 2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) and FOLFOXIRI in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer is a phase 2, randomised interventional study registered as NCT05571644 by Sun Yat-sen University, with a registry enrolment figure of 143 participants, started 2023-07-10 and due to reach its primary completion in 2025-12-31. Interventions recorded: mFOLFOXIRI + Cadonilimab; mFOLFOX6; mFOLFOXIRI; mFOLFOXIRI+AK104+fruquintinib. Conditions listed: Colorectal Cancer. Primary outcome: Pathological complete response (pCR) rates. Colorectal eligibility wording from the registry: \"Colorectal adenocarcinoma with definite histological evidence;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05571644","url":"https://clinicaltrials.gov/study/NCT05571644"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfox","folfoxiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05571644","phase":"2","setting":"Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 Alone in Locally Advanced Colorectal Cancer: a Randomized Control Phase II Study (OPTICAL-2)","sponsor":"Sun Yat-sen University","enrolled":143,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05571644/","neighbours":{"cancer":[{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-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":"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":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"},{"id":"folfoxiri","kind":"drug","name":"FOLFOXIRI (5-FU, leucovorin, oxaliplatin, irinotecan)","route":"/drugs/folfoxiri/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}