OncoMatch/Clinical Trials/NCT07458529
Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer
Is NCT07458529 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies CRT+PD-1 inhibitor+Probio-M9 for rectal cancer, adenocarcinoma.
Treatment: CRT+PD-1 inhibitor+Probio-M9 — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage II, III
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-tumor treatment
No prior anti-tumor treatment (e.g., radiotherapy, chemotherapy, immunotherapy, biological therapy, or herbal therapy)
Cannot have received: anti-cancer treatment
Receipt of any anti-cancer treatment (e.g., surgery, chemotherapy, radiotherapy, or other systemic therapies) within the past 5 years
Lab requirements
Blood counts
Neutrophils ≥ 1.5 × 10^9/L; Hemoglobin ≥ 80 g/L; Platelets ≥ 100 × 10^9/L
Kidney function
Serum creatinine ≤ 1.5 × ULN
Liver function
ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 × ULN
Adequate hematologic and biochemical function including: Neutrophils ≥ 1.5 × 10^9/L; Hemoglobin ≥ 80 g/L; Platelets ≥ 100 × 10^9/L; Serum creatinine ≤ 1.5 × ULN; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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