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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.
Sponsor: Zhejiang Cancer Hospital
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-03-20
Completion Date
2025-12-31
Last Updated
2024-08-27
Healthy Volunteers
No
Conditions
Interventions
Hypofractionated radiotherapy/SBRT(5-10Gy/fx,3-5 fx)
RT: one primary or metastatic focus was selected for hypofractionated radiotherapy/SBRT (5-10 Gy/fx, 3-5 fx) in each round, the target area included only the GTV of the visible tumor lesion, and the GTV was expanded by 5-10 mm to generate the PTV, and the prophylactic lymphatic drainage area could not be irradiated.
Anti-PD-1 monoclonal antibody
Sintilimab 200mg d1 iv q3w
Oxaliplatin and Capecitabine
Oxaliplatin130mg/m2 d1 iv;Capecitabine1000mg/m2 d1-d14
Anti-VEGF 15mg/kg
Bevacizumab 15mg/kg d1 iv q3w
Anti-VEGF 7.5mg/kg
Bevacizumab 7.5mg/kg d1 iv q3w
Gemcitabine and Cisplatin
Gemcitabine1000mg/m2 d1 d8 iv;Cisplatin 25mg/m2 d1 d8 iv q3w
Locations (1)
Zhengjiang Cancer Hospital
Hangzhou, Zhejiang, China