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Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

Locally Advanced Rectal Cancer Clinical Trial

Official title:
Efficacy and Safety of Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin in pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: An Open, Multi-center, Prospective, Single-arm Phase II Clinical Study

Clinical Trial Summary

This is an open, prospective, multi-center, single-arm phase II clinical study assessing the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin in patients with pMMR/MSS locally advanced middle and low rectal cancer.

Clinical Trial Description

This study is an open, prospective, multi-center, single-arm phase II clinical study. In this study, patients with pMMR/MSS locally advanced middle and low rectal cancer were selected as the subjects and treated with neoadjuvant treatment protocol of long-course concurrent chemoradiotherapy combined with PD-1 monoclonal antibody and thymalfasin. The primary endpoint of the study was pathological complete response (pCR) rate. The secondary study endpoints were neoadjuvant rectal (NAR) score, objective response rate (ORR), R0 resection rate, anal preservation rate, 3-year disease-free survival (DFS) rate, 3-year local recurrence-free survival (LRFS) rate, 3-year overall survival (OS) rate, tumor regression grade (TRG), safety and tolerability. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06056804
Study type Interventional
Source Beijing Friendship Hospital
Contact Zhongtao Zhang, MD
Phone +86 13801060364
Email Zhangzht@ccmu.edu.cn
Status Not yet recruiting
Phase Phase 2
Start date December 1, 2023
Completion date July 1, 2027
View Details
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