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.
NCT ID: NCT06349044
Last Updated: 2024-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-03-20
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ARM A:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma
patients will receive Probio-M9 ,RT followed by Immunotherapy-Based Systemic Therapy
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
ARM A*:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma
patients will receive placebo ,RT followed by Immunotherapy-Based Systemic Therapy
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
ARM B: Liver adenocarcinoma
patients will receive Probio-M9 ,RT followed by Immunotherapy-Based Systemic Therapy
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
Anti-VEGF 15mg/kg
Bevacizumab 15mg/kg d1 iv q3w
ARM B*: Liver adenocarcinoma
patients will receive placebo ,RT followed by Immunotherapy-Based Systemic Therapy
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
Anti-VEGF 15mg/kg
Bevacizumab 15mg/kg d1 iv q3w
ARM C: Malignant tumors of the biliary system
patients will receive Probio-M9 ,RT followed by Immunotherapy-Based Systemic Therapy
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
Gemcitabine and Cisplatin
Gemcitabine1000mg/m2 d1 d8 iv；Cisplatin 25mg/m2 d1 d8 iv q3w
ARM C*: Malignant tumors of the biliary system
patients will receive placebo ,RT followed by Immunotherapy-Based Systemic Therapy
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
Gemcitabine and Cisplatin
Gemcitabine1000mg/m2 d1 d8 iv；Cisplatin 25mg/m2 d1 d8 iv q3w
ARM D:Colorectal cancer
patients will receive Probio-M9 ,RT followed by Immunotherapy-Based Systemic Therapy
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 7.5mg/kg
Bevacizumab 7.5mg/kg d1 iv q3w
ARM D*:Colorectal cancer
patients will receive placebo ,RT followed by Immunotherapy-Based Systemic Therapy
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 7.5mg/kg
Bevacizumab 7.5mg/kg d1 iv q3w
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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;
* ECOG score of 0-1;
* be able to accept the treatment regimen during the study;
* sign a written informed consent.
Exclusion Criteria
* 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;
* a history of other malignant disease within the last five years;
* persons with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
* Subjects whose baseline blood routine and biochemical indexes do not meet the following criteria: hemoglobin ≥80g/L; absolute neutrophil count (ANC) ≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; and serum creatinine \<1 times the upper limit of normal. times the upper limit of normal;
* the patient currently has active gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator;
* persons with active bleeding or bleeding tendencies;
* women who are pregnant or breastfeeding;
* allergy to any of the study drug ingredients.
18 Years
75 Years
ALL
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Ji Zhu
Professor
Locations
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Zhengjiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BASIMA
Identifier Type: -
Identifier Source: org_study_id
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