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Combination of AK104 and Neoadjuvant Chemoradiotherapy in pMMR/MSS Locally Advanced Rectal Cancer

Locally Advanced Rectal Cancer Clinical Trial

Official title:
A Phase II Trial of AK104 Combined With Neoadjuvant Chemoradiotherapy in Proficient Mismatch Repair/Microsatellite Stable Locally Advanced Rectal Cancer

Clinical Trial Summary

This is an open-label, single-arm study to investigate the efficacy and safety of AK104 (an Anti-PD1 and Anti-CTLA4 Bispecific Antibody) and neoadjuvant chemoradiotherapy in patients with pMMR/MSS locally advanced rectal cancer.

Clinical Trial Description

The study evaluates the addition of AK104(an Anti-PD1 and Anti-CTLA4 Bispecific Antibody) in neoadjuvant chemoradiotherapy in proficient Mismatch Repair (pMMR) /Microsatellite Stable (MSS) locally advanced rectal cancer (LARC). A total of 33 pMMR/MSS LARC patients will receive long-course chemoradiotherapy plus 2 cycles of AK104, followed by another 3 cycles of AK104, finally received clinical routine manage. The tumor response to treatment, adverse effects and long-term prognosis will be analyzed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05980689
Study type Interventional
Source Sun Yat-sen University
Contact WeiWei Xiao
Phone 8613710390520
Email xiaoww@sysucc.org.cn
Status Recruiting
Phase Phase 2
Start date October 24, 2023
Completion date January 31, 2025
View Details
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