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).
Age ≥ 18 years
ECOG performance status 0-2
Biopsy-proven rectal adenocarcinoma
Distal tumor margin within 10 cm of the anal verge
History of multiple primary cancers or concomitant malignant tumors other than rectal cancer
Receipt of any anti-cancer treatment (e.g., surgery, chemotherapy, radiotherapy, or other systemic therapies) within the past 5 years
History of recent major surgery
Conditions that may affect the gastrointestinal absorption of capecitabine (e.g., inability to swallow, persistent nausea or vomiting, chronic diarrhea)
Seventh Medical Center of PLA General Hospital
Lead sponsor