RecruitingPhase 2NCT05972655

Nodes-sparing Short-course Radiation Combined With CAPOX and Tislelizumab for MSS Middle and Low Rectal Cancer

Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer (mRCAT): An Open-label, Single-arm, Prospective Multicenter Clinical Trial


Sponsor

Sir Run Run Shaw Hospital

Enrollment

32 participants

Start Date

Aug 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, prospective, multicenter phase II clinical trial to evaluate modified short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) for patients with MSS middle and low rectal cancer. A total of 32 patients will be enrolled in this trial. The primary endpoint is the rate of pathological complete response (pCR). The organ preservation rate, tumor regression grade, 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 clinical trial is studying a drug called Capecitabine, Modified short-course radiotherapy, and others for people with low rectal cancer. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

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

RADIATIONModified 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


Locations(1)

Sir Run Run Shao hospital

Hanzhou, Zhejiang, China

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NCT05972655


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