RecruitingNot ApplicableNCT06349044

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.

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

Enrollment

120 participants

Start Date

Mar 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment approach for advanced digestive system cancers that combines focused radiation with immunotherapy, and also looks at whether adding a probiotic (a beneficial gut bacteria called L. rhamnosus M9) improves outcomes. **You may be eligible if...** - You have been diagnosed with an advanced cancer of the digestive system — including stomach, liver, bile duct, or colorectal cancer — that cannot be surgically removed - You have not received any previous cancer treatment - You are between 18 and 75 years old and in good general health - You have at least one measurable tumor - You are able to receive chemotherapy and/or immunotherapy **You may NOT be eligible if...** - You have brain metastases - You have already received treatment for your cancer - You have major heart or blood vessel problems - You have a condition that prevents you from receiving chemotherapy or immunotherapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypofractionated 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.

DRUGAnti-PD-1 monoclonal antibody

Sintilimab 200mg d1 iv q3w

DRUGOxaliplatin and Capecitabine

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

DRUGAnti-VEGF 15mg/kg

Bevacizumab 15mg/kg d1 iv q3w

DRUGAnti-VEGF 7.5mg/kg

Bevacizumab 7.5mg/kg d1 iv q3w

DRUGGemcitabine and Cisplatin

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


Locations(1)

Zhengjiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06349044


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