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.

ConditionsHer-2 Negative Adenocarcinoma of the Gastro-oesophageal Junction/Gastric Adenocarcinoma Hepatocellular Carcinoma Biliary Tract Carcinoma Colorectal Adenocarcinoma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorZhejiang Cancer Hospital

About this trial

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 criteria

Qualifiers

histopathologically confirmed diagnosis of malignant tumors of the gastrointestinal tract (including Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma, hepatocellular carcinoma, malignant tumors of the biliary system, colorectal cancer);

advanced patients evaluated as initially non-operable resectable who have not received any antitumor therapy;

have at least one measurable or evaluable lesion according to RECIST v1.1 criteria in addition to the primary lesion, with non-operable resectable lymph node metastases to the liver, lung, bone, pelvis, retroperitoneum and/or superficial sites (except for brain metastases), as evaluated by discussion in the framework of the MDT

age 18-75 years;

Disqualifiers

a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder of clinical severity that, in the judgment of the investigator, may preclude the signing of an informed consent form or interfere with the patient's adherence to oral medication;

prior immunotherapy for any indication or a history of severe hypersensitivity reactions to other monoclonal antibodies;

clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmias requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months;

organ transplantation requiring immunosuppressive therapy;

Trial design

Treatments tested in this trial

Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）
Anti-PD-1 monoclonal antibody
Oxaliplatin and Capecitabine
Anti-VEGF 15mg/kg
Anti-VEGF 7.5mg/kg
Gemcitabine and Cisplatin

Treatment groups

120 Participants

are divided into 8 treatment groups

Treatment groups

See each treatment group below.

Sponsors and collaborators

Zhejiang Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov