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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT07458529 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages