RecruitingPhase 2NCT05576480

SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer

Efficacy and Safety of Short-course Radiotherapy Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of Microsatellite Stable Locally Advanced Rectal Cancer: a Single-centre, Single-arm, Phase 2 Study

Sponsor

Ruijin Hospital

Enrollment

55 participants

Start Date

Feb 6, 2023

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer Locally Advanced

Summary

The goal of this phase 2 study is to learn about the efficacy and safety of short-course radiotherapy (SCRT) sequential Penpulimab in combination with CAPEOX in the neoadjuvant treatment of microsatellite stable (MSS) locally advanced rectal cancer. The main question it aims to answer is the role of immune checkpoint inhibitors in the neoadjuvant treatment of MSS rectal cancer. Participants will receive neoadjuvant treatment of SCRT sequential Penpulimab in combination with CAPEOX. Participants will undergo a clinical re-staging assessment at the end of neoadjuvant therapy to determine whether to adopt a watch-and-wait strategy or undergo radical surgery.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing short-course radiation therapy followed by immunotherapy (penpulimab) and chemotherapy (CAPEOX) before surgery for people with locally advanced rectal cancer that does not have a specific DNA mismatch feature (called MSS). The goal is to see if this combination can better shrink the tumor before surgery. **You may be eligible if...** - You are between 18 and 75 years old and in good health (ECOG 0–1) - You have been diagnosed with rectal adenocarcinoma, confirmed by biopsy, that is locally advanced (stage II–III) - Your tumor is in the mid-to-lower rectum (within 10 cm of the anal opening) - Your tumor is MSS (microsatellite stable, confirmed by testing) - You have not received any prior treatment for your rectal cancer - You have no distant spread of cancer **You may NOT be eligible if...** - Your cancer has spread to other organs - You have already received cancer treatment - You have significant organ function problems 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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