# Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer

Source: https://onco.cc/trials/nct05571644/  
OnCo record `nct05571644` (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 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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Also known as: OPTICAL-2
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: 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

## Sources

- ClinicalTrials.gov NCT05571644: https://clinicaltrials.gov/study/NCT05571644

## Connected records

- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Platinum agents](https://onco.cc/technologies/platinum/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- drugs: [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/), [FOLFOXIRI (5-FU, leucovorin, oxaliplatin, irinotecan)](https://onco.cc/drugs/folfoxiri/)
- 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/nct05571644.json