drugset / Trial / NCT07458529
Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Probio-M9 | Unknown | 2 g | Oral |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |