RecruitingPhase 3NCT06507371

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

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)


Sponsor

Sir Run Run Shaw Hospital

Enrollment

170 participants

Start Date

Jul 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new treatment approach for low rectal cancer in patients who want to avoid a permanent colostomy (bowel bag). It combines short-course radiation with chemotherapy (CAPOX) and an immunotherapy drug called tislelizumab, given before surgery, in patients whose cancer is microsatellite stable (MSS) — a type that typically does not respond as well to immunotherapy alone. **You may be eligible if...** - You are 18–75 years old with low rectal cancer (tumor within 10 cm of the anal opening) at clinical stage T3–T4b - Your cancer has been confirmed as MSS or pMMR by genetic testing - You strongly wish to preserve the anus and avoid a permanent colostomy - You have not had any prior cancer treatment - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - You have had a previous cancer other than rectal cancer - Your cancer has spread to distant organs - Your cancer has spread to lymph nodes outside the rectum's surrounding fat - You have a bowel blockage, perforation, or bleeding requiring emergency surgery - You have had prior pelvic radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONnode-sparing modified short-course radiotherapy

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

DRUGPD-1 antibody

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

DRUGCapecitabine

Capecitabine: 1000mg/m2 d1-14 q3w

DRUGOxaliplatin

Oxaliplatin: 130mg/m2 d1 q3w

RADIATIONstandard 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

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NCT06507371


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