drugset / Trial / NCT07458529

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

NCT07458529 ↗

Phase 2 Recruiting 50 enrolled Seventh Medical Center of PLA General Hospital
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2026-02-10
Primary completion
2027-05-05
Completion
2030-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Probio-M9 Unknown 2 g Oral
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous

Indications