PD-1 Antibody Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer

Phase 2 Active not recruiting 30 enrolled Sun Yat-sen University Fudan University · collab Liaoning Cancer Hospital & Institute · collab

NaSingle-groupOpen-labelTreatment

Summary

In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 antibody following preoperative Chemoradiotherapy with capecitabine for pMMR/MSS rectal cancer staged as locally advanced (cT3-T4N+/-M0 for rectal cancer). This treatment will be given during the window period until surgical resection of the tumor.

Timeline

Start: 2021-01-01
Primary completion: 2024-12-31
Completion: 2026-12-31

Outcome

Missed primary endpoint

paper Although the target pCR rate was not fully achieved PMID 40652024 ↗

Publications

Hou Z, Liao L, Xiao W, Sui Q, Han K, Xiao B, Li Y, Mei W, Yu J, Hong Z, Chen Q, Song R, Li D, Zhang X, Wang Q, Pan Z, Jiang W, Ding P. Neoadjuvant chemoradiotherapy plus sintilimab in pMMR/MSS rectal cancer patients with PD-L1 TPS >/= 1% or CPS >/= 1: an open-label, prospective, phase II study. NPJ Precis Oncol. 2025 Jul 12;9(1):237. doi: 10.1038/s41698-025-01018-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sintilimab	Monoclonal antibody	200 mg	—
Background	Capecitabine	Small molecule	1650 mg/m2	—