{"entity":{"id":"nct07381400","kind":"trial","name":"Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)","aka":[],"tldr":"A phase 2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) and serplulimab in colorectal cancer, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, not yet recruiting.","summary":"Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study) is a phase 2, randomised interventional study registered as NCT07381400 by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, with a registry enrolment figure of 128 participants, started 2026-02-01 and due to reach its primary completion in 2028-02-01. Interventions recorded: mFOLFOX6; Serplulimab. Conditions listed: Rectal Cancer. Primary outcome: Pathological Complete Response Rate (pCR). Colorectal eligibility wording from the registry: \"Rectal cancer patients with MRI showing the lower edge of the tumor within 15 cm of the anal verge, cT3-4 N any or cT any N1/2;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07381400","url":"https://clinicaltrials.gov/study/NCT07381400"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07381400","phase":"2","setting":"A Multicenter, Randomized Controlled Clinical Study of Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)","sponsor":"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine","enrolled":128,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07381400/","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":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"drug":[{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"},{"id":"serplulimab","kind":"drug","name":"Serplulimab","route":"/drugs/serplulimab/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}