Phase II Study of Hypofractionated Radiotherapy and Immunotherapy with or without L. Rhamnosus M9 for First-Line Treatment of Advanced Digestive System Cancers

What this Trial Is About

Researchers are evaluating a combined treatment approach for advanced gastrointestinal tumors, focusing on the interaction between radiation therapy and immunotherapy. The study aims to design a first-line treatment protocol using macrofractionated radiotherapy to activate the immune system, along with the potential synergistic effects of the Probio-M9 microbial agent and PD-1 inhibitors. This randomized, multicenter phase II basket study includes patients with various advanced digestive system malignancies such as gastric adenocarcinoma, hepatocellular carcinoma, biliary tract carcinoma, and colorectal adenocarcinoma. Participants are assigned to receive either Probio-M9 with hypofractionated radiotherapy or a placebo with radiotherapy, followed by immunotherapy-based systemic treatments. The radiotherapy involves targeting one primary or metastatic tumor focus with doses of 5-10 Gy per fraction over 3-5 fractions. Immunotherapy includes administration of anti-PD-1 monoclonal antibodies and chemotherapy agents such as oxaliplatin, capecitabine, bevacizumab, gemcitabine, and cisplatin, depending on the cancer type. The study groups correspond to specific tumor types and compare the effects of adding Probio-M9 to standard treatment. During the study, participants will be monitored through assessments of tumor response using the objective response rate ORR at two months after radiotherapy. Additional evaluations include adverse effects, quality of life, progression-free survival, and overall survival with follow-ups lasting up to 10 years. Safety and treatment adherence will be closely observed. The total participation timeline includes regular clinical visits and assessments to measure treatment outcomes and patient well-being.

A Randomized, Multicenter Phase II Basket Study of Hypofractionated Radiotherapy/Stereotactic Body Radiotherapy Followed by Immunotherapy-Based Systemic Therapy +/- L. Rhamnosus M9 for the First-Line Treatment of Advanced Digestive System Malignancies.