Cadonilimab + FOLFOX Versus FOLFOX in the Neoadjuvant Treatment of pMMR/MSS Locally Advanced Colorectal Cancer

Locally Advanced Colorectal Carcinoma Clinical Trial

Official title: Comparison of Cetuximab Combined With Chemotherapy Versus Chemotherapy Alone in the Neoadjuvant Treatment of Locally Advanced pMMR/MSS Colorectal Cancer: a Randomized, Open-label, Single-center Phase II Clinical Study

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to compare the efficacy and safety of the combination of Cadonilimab and FOLFOX regimen compared to FOLFOX regimen alone in the neoadjuvant chemotherapy of pMMR/MSS locally advanced colorectal cancer. The main question aims to answer are:

Question 1: Compare the pathological complete response rate between the combination of Cadonilimab and FOLFOX regimen and the FOLFOX alone.

Question 2: Compare the survival outcomes and safety between the combination of Cadonilimab and FOLFOX regimen and the FOLFOX alone.

Two groups of participants will receive different new adjuvant chemotherapy regimens, and their efficacy will be compared.

Clinical Trial Description

A prospective, randomized, open, single-center clinical study evaluating the efficacy (pathological response, survival outcomes) and safety of the combination of Cadonilimab and FOLFOX regimen compared to FOLFOX regimen in the treatment of locally advanced colorectal cancer with proficient mismatch-repair (pMMR) or microsatellite stable (MSS) protein expression. ;

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Locally Advanced Colorectal Carcinoma

• NCT number: NCT06154538
• Study type: Interventional
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Qian Liu
• Phone: +8618610506948
• Email: fcwpumch@163.com
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2023
• Completion date: November 1, 2028