Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in Locally Advanced Rectal Cancer (UNION)

Rectal Cancer Clinical Trial

Official title: A Multicenter, Randomized, Open-label, Controlled Phase III Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in the Treatment for Locally Advanced Rectal Cancer

Status Active, not recruiting

Clinical Trial Summary

The study is a multicenter, open-label, randomized controlled clinical study, and the purpose of the study is to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-term radiotherapy, sequential Camrelizumab and CAPOX (group A) to long-term concurrent chemoradiotherapy, sequential CAPOX (group B) in patients with LARC. A total of 230 patients were included in this study.

Clinical Trial Description

Patients with locally advanced rectal cancer (T3-4/N+) were randomly assigned to experimental group A or control group B according to the ratio of 1:1,who will receive preoperative neoadjuvant therapy, and the Primary endpoint of the study is Pathological complete response rate(PCR ) assessed by the blind independent review committee (BIRC), defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0) ;

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

• NCT number: NCT04928807
• Study type: Interventional
• Source: Wuhan Union Hospital, China
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 20, 2021
• Completion date: March 20, 2026