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

NCT06507371 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-06-26

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Sir Run Run Shaw Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-29
Primary Completion
2026-02-15
Completion
2026-08-15

Countries

  • China

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06507371 on ClinicalTrials.gov