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OncoMatch/Clinical Trials/NCT05576480

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

Is NCT05576480 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Penpulimab and CAPEOX for rectal cancer.

Phase 2RecruitingRuijin HospitalNCT05576480Data as of May 2026

Treatment: Penpulimab · CAPEOXThe 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.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Required: Stage II, III

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: pelvic radiotherapy

Previous treatment with pelvic radiotherapy

Cannot have received: rectal cancer surgery

Previous treatment with rectal cancer surgery

Cannot have received: chemotherapy

Previous treatment with chemotherapy

Cannot have received: targeted therapy

Previous treatment with targeted therapy

Cannot have received: immune checkpoint inhibitor

Previous treatment with immune checkpoint inhibitors (including but not limited to PD-1, PD-L1, CTLA-4)

Lab requirements

Blood counts

Adequate organ and bone marrow function

Kidney function

Adequate organ and bone marrow function

Liver function

Adequate organ and bone marrow function

Adequate organ and bone marrow function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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