RecruitingPhase 2NCT07458529

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

Neoadjuvant Chemoradiotherapy Combined With Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: A Single-Center, Prospective, Randomized Controlled Trial (NCRIT-PM9 Trial)


Sponsor

Seventh Medical Center of PLA General Hospital

Enrollment

50 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a probiotic supplement (Probio-M9) to standard treatment—which combines chemotherapy, radiation, and an immunotherapy drug (tislelizumab)—can improve outcomes for patients with locally advanced rectal cancer. Researchers think that gut bacteria may influence how well the immune system responds to cancer treatment. **You may be eligible if...** - You are 18 or older with confirmed rectal cancer (a type of colon cancer at the end of the bowel) - Your cancer is locally advanced (stage II or III) based on MRI, and has not spread to distant organs - Your tumor is within 10 cm of the anal opening - You have not received any prior cancer treatment - You do not have an immune system disorder, significant organ dysfunction, or active infection **You may NOT be eligible if...** - You have previously had any anti-cancer treatment (surgery, chemotherapy, radiation, or immunotherapy) in the past 5 years - You have another active cancer - You have conditions affecting how your body absorbs oral medications - You are on immunosuppressive drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTCRT+PD-1 inhibitor+Probio-M9

Chemoradiation with PD-1 inhibitor (tislelizumab), with or without Probio-M9. Probio-M9 is administered orally at a dose of 2 g (one sachet) once daily. Treatment begins at the initiation of neoadjuvant chemoradiotherapy and continues until the day before surgical resection.

COMBINATION_PRODUCTCRT+PD-1 inhibitor+placebo

Chemoradiation with PD-1 inhibitor (tislelizumab) with placebo. Placebo is administered orally at a dose of 2 g (one sachet) once daily. Treatment begins at the initiation of neoadjuvant chemoradiotherapy and continues until the day before surgical resection.


Locations(1)

Seventh Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

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NCT07458529


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