{"entity":{"id":"nct05969847","kind":"trial","name":"Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer","aka":["TRACE-LE"],"tldr":"A phase 2 trial of cAPOX (capecitabine, oxaliplatin) and envafolimab in colorectal cancer, run by 池畔, not yet recruiting.","summary":"Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer is a phase 2, interventional study registered as NCT05969847 by 池畔, with a registry enrolment figure of 72 participants, started 2023-08-15 and due to reach its primary completion in 2027-12-31. Interventions recorded: split-course hypofraction radiotherapy; CAPOX; Envafolimab; Local excision. Conditions listed: Rectal Cancer. Primary outcome: Organ preservation. Colorectal eligibility wording from the registry: \"Histopathology confirmed the rectal adenocarcinoma,cT3-4N0 or cT1-4N1-2\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05969847","url":"https://clinicaltrials.gov/study/NCT05969847"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capox","envafolimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05969847","phase":"2","setting":"Total Neoadjuvant Therapy With Split-course Hypofraction Radiotherapy Combined With CAPOX and Envafolimab Followed by Local Excision for Locally Advanced Very Low Rectal Cancer: an Open-label, Single-arm, Multi-center, Phase II Trial","sponsor":"池畔","enrolled":72,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05969847/","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/"}],"drug":[{"id":"capox","kind":"drug","name":"CAPOX (capecitabine, oxaliplatin)","route":"/drugs/capox/"},{"id":"envafolimab","kind":"drug","name":"Envafolimab","route":"/drugs/envafolimab/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}