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

Summary

Neoadjuvant chemoradiotherapy (CRT) followed by total mesenteric excision (TME) and adjuvant chemotherapy was the standard of treatment for locally advanced rectal cancer (LARC) in the past two decades. The main obstacles for improving survival benefit of LARC was distant metastasis. Recently, total neoadjuvant therapy (TNT) had been recommended as new preferred option for LARC. Induction chemotherapy with FOLFOXIRI followed by CRT or short-course radiotherapy followed by FOLFOX chemotherapy had improved survival benefit for LARC. Neoadjuvant immunotherapy had also been explored in pMMR patients with CRC. In the NICHE trial, neoadjuvant therapy with 2 dose of nivolumab and 1 dose of ipilimumab led to 29% of pathological response and 13% of pCR. Cadonilimab (AK104) was a PD-1/CTLA-4 bi-specific antibody. Here, we tried to explore the efficacy of Neoadjuvant Treatment With mFOLFOXIRI with or without Cadonilimab (AK104) Versus mFOLFOX6 in LARC.

Timeline

Start

2023-07-10

Primary completion

2025-12-31

Completion

2027-08-15

Publications

• Zhang J, Qi S, Hu H, He X, Huang L, Zhou J, Wang H, Wu X, Kang L, Huang M, He Z, Wang H, Chen D, Zhai X, Xie X, Ling J, Zhang Y, Hu J, Li S, Wu Z, Yang T, Cai R, Cai Y, Zhong L, Li W, Shi L, Wang C, Huang Y, Zhao Y, Cao W, Qin G, Deng Y. Neoadjuvant mFOLFOXIRI with or without cadonilimab versus mFOLFOX6 in locally advanced colorectal cancer: A randomized phase 2 trial (OPTICAL-2). Med. 2026 Jun 12;7(6):101141. doi: 10.1016/j.medj.2026.101141. Epub 2026 May 13.

Drugs

Indications