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.

Recruiting 120 enrolled Zhejiang Cancer Hospital

RandomizedParallel-groupDouble-blindTreatment

Summary

Based on the interaction between radiation therapy and immunotherapy and the potential potentiation of Probio-M9 for the treatment of ICIs, this study is planned to design an integrated treatment protocol for the first-line treatment of advanced gastrointestinal tumors through the use of macrofractionated radiotherapy as a means of immune activation, combined with the synergistic effect of Probio-M9 microbial agents and PD-1 inhibitors.

Timeline

Start: 2024-03-20
Primary completion: 2025-12-31
Completion: 2025-12-31

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Bevacizumab	Monoclonal antibody	7.5 mg/kg	Intravenous
Background	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Background	Capecitabine	Small molecule	1000 mg/m2	Intravenous
Background	Cisplatin	Other / unclassified	25 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	130 mg/m2	Intravenous
Background	Sintilimab	Monoclonal antibody	200 mg	Intravenous

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.

Summary

Timeline

Drugs

Indications