Clinical Trial

Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer

Study acronym: NCRIT-PM9
Recruiting Phase 2
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Summary
This prospective, single-center, randomized controlled trial aims to assessing the efficacy and safety of neoadjuvant chemoradiation plus Tislelizumab (PD-1 inhibitor) with or without Probio-M9 and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+PD-1 inhibitor+Probio-M9; Experiment group 2: chemoradiation+PD-1 inhibitor+placebo) with a control group (chemoradiation only).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-04.
Trial Details
NCT Number NCT07458529
Lead Sponsor Seventh Medical Center of PLA General Hospital
Conditions Rectal Cancer, Adenocarcinoma, Neoadjuvant Therapy, Immunotherapy, Probio-M9, Tislelizumab, Randomized
Enrollment 50 participants
Start Date 2026-02-10
Primary Completion 2027-05-05 (estimated)
Study Completion 2030-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-10