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Brief Title: Cadonilimab + FOLFOX Versus FOLFOX in the Neoadjuvant Treatment of pMMR/MSS Locally Advanced Colorectal Cancer
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
Study ID: NCT06154538
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer Hospital/ National Cancer Center, Chinese Academy of Medical Sciences, Beijing, Beijing, China
Name: Qian Liu
Affiliation: vice director of colorectal surgery dept.
Role: PRINCIPAL_INVESTIGATOR
Name: Jing Huang
Affiliation: vice director of medical oncology dept.
Role: STUDY_DIRECTOR