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

• Status: Not yet recruiting
• Trial end date: 2025-12-15

Summary

Neoadjuvant chemoradiotherapy (CRT) followed by total mesenteric excision (TME) and adjvuant chemotherapy was the standard of treatment for locally advanced rectal cancer (LARC) i 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 ipilumumab 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 Plus Cadonilimab (AK104) Versus mFOLFOX6 in LARC.

• Phase: Phase 2

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin