# Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)

Source: https://onco.cc/trials/nct07381400/  
OnCo record `nct07381400` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-24
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: 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

## Sources

- ClinicalTrials.gov NCT07381400: https://clinicaltrials.gov/study/NCT07381400

## Connected records

- cancers: [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/), [Serplulimab](https://onco.cc/drugs/serplulimab/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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JSON: https://onco.cc/api/v1/entities/nct07381400.json