NCT06349044View on ClinicalTrials.gov

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.

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

March 20, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Her-2 Negative Adenocarcinoma of the Gastro-oesophageal Junction/Gastric AdenocarcinomaHepatocellular CarcinomaBiliary Tract CarcinomaColorectal Adenocarcinoma
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

Trial Locations (1)

Unknown

RECRUITING

Zhengjiang Cancer Hospital, Hangzhou

All Listed Sponsors
lead

Zhejiang Cancer Hospital

OTHER