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RECRUITING
NCT05576480
PHASE2

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2023-02-06

Completion Date

2026-12

Last Updated

2025-08-28

Healthy Volunteers

No

Interventions

RADIATION

Short-course radiotherapy

5×5Gy in Week 1

DRUG

Penpulimab

Apply once in the first week, then every 3 weeks from the third week for four cycles

DRUG

CAPEOX

Apply every 3 weeks from week 3 for 4 cycles

PROCEDURE

TME surgery

Patient will receive radical rectal cancer surgery

Locations (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, None Selected, China