Clinical Trial

Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer

Recruiting Phase 2
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Record status
This record was last updated January 10, 2024 (before its estimated March 1, 2024 completion). Its status may not reflect the trial's current state.
Summary
This is a phase II/III, multi-center, open-label, 3-arm, randomized controlled trial assessing the efficacy and safety of neoadjuvant long-course chemoradiation combined with Tislelizumab (PD-1 inhibitor) and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+concurrent PD-1 inhibitor; Experiment group 2: chemoradiation+sequential PD-1 inhibitor) with a control group (chemoradiation only).
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2022-02-06; most recent amendment 2024-01-09.
Status change: Not Yet Recruiting → Recruiting 2023-03-14
Trial Details
NCT Number NCT05245474
Lead Sponsor Beijing Friendship Hospital
Collaborators: Beijing Chao Yang Hospital, Xuanwu Hospital, Beijing, Beijing Hospital, Peking Union Medical College Hospital, Peking University First Hospital, Peking University People's Hospital, Peking University Cancer Hospital & Institute, BeiGene
Conditions Locally Advanced Rectal Cancer
Enrollment 186 participants
Start Date 2022-04-01
Primary Completion 2024-03-01 (estimated)
Study Completion 2029-09-01 (estimated)
Updated on ClinicalTrials.gov 2024-01-10