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RECRUITING
NCT06349044
NA

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

View on ClinicalTrials.gov

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

Interventions

RADIATION

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.

DRUG

Anti-PD-1 monoclonal antibody

Sintilimab 200mg d1 iv q3w

DRUG

Oxaliplatin and Capecitabine

Oxaliplatin130mg/m2 d1 iv;Capecitabine1000mg/m2 d1-d14

DRUG

Anti-VEGF 15mg/kg

Bevacizumab 15mg/kg d1 iv q3w

DRUG

Anti-VEGF 7.5mg/kg

Bevacizumab 7.5mg/kg d1 iv q3w

DRUG

Gemcitabine and Cisplatin

Gemcitabine1000mg/m2 d1 d8 iv;Cisplatin 25mg/m2 d1 d8 iv q3w

Locations (1)

Zhengjiang Cancer Hospital

Hangzhou, Zhejiang, China