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RECRUITING
NCT06507371
PHASE3

Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer

Sponsor: Sir Run Run Shaw Hospital

View on ClinicalTrials.gov

Summary

This is a randomized, prospective, multicenter, open-label, Phase III clinical trial to evaluate node-sparing modified short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) compared with standard short-course radiation combined with CAPOX for patients with MSS middle and low rectal cancer. A total of 170 patients will be enrolled in this trial. The primary endpoint is the rate of pathological complete response (pCR). The EFS rate, ORR, organ preservation rate, long-term prognosis, and adverse effects will also be analyzed.

Official title: Node-sparing Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer : An Randomized, Prospective, Multicenter, Open-label, Phase III Clinical Trial (mRCAT-III)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2024-07-29

Completion Date

2026-08-15

Last Updated

2025-06-26

Healthy Volunteers

No

Conditions

Interventions

RADIATION

node-sparing modified short-course radiotherapy

radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes: 25Gy/5Fx

DRUG

PD-1 antibody

PD-1 antibody (Tislelizumab): 200mg d1 q3w

DRUG

Capecitabine

Capecitabine: 1000mg/m2 d1-14 q3w

DRUG

Oxaliplatin

Oxaliplatin: 130mg/m2 d1 q3w

RADIATION

standard short-course radiotherapy

radiation targeting the tumor bed and surrounding tumor-draining lymph nodes: 25Gy/5Fx

Locations (1)

Sir Run Run Shao hospital

Hanzhou, Zhejiang, China