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Trial 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.
NCT ID:
NCT06349044
Condition:
Her-2 Negative Adenocarcinoma of the Gastro-oesophageal Junction/Gastric Adenocarcinoma
Hepatocellular Carcinoma
Biliary Tract Carcinoma
Colorectal Adenocarcinoma
Conditions: Official terms:
Carcinoma
Adenocarcinoma
Gemcitabine
Capecitabine
Oxaliplatin
Antibodies
Antibodies, Monoclonal
Conditions: Keywords:
radiotherapy
immunotherapy
L. rhamnosus M9
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Radiation
Intervention name:
Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）
Description:
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.
Arm group label:
ARM A*:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma
Arm group label:
ARM A:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma
Arm group label:
ARM B*: Liver adenocarcinoma
Arm group label:
ARM B: Liver adenocarcinoma
Arm group label:
ARM C*: Malignant tumors of the biliary system
Arm group label:
ARM C: Malignant tumors of the biliary system
Arm group label:
ARM D*:Colorectal cancer
Arm group label:
ARM D:Colorectal cancer
Intervention type:
Drug
Intervention name:
Anti-PD-1 monoclonal antibody
Description:
Sintilimab 200mg d1 iv q3w
Arm group label:
ARM A*:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma
Arm group label:
ARM A:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma
Arm group label:
ARM B*: Liver adenocarcinoma
Arm group label:
ARM B: Liver adenocarcinoma
Arm group label:
ARM C*: Malignant tumors of the biliary system
Arm group label:
ARM C: Malignant tumors of the biliary system
Arm group label:
ARM D*:Colorectal cancer
Arm group label:
ARM D:Colorectal cancer
Intervention type:
Drug
Intervention name:
Oxaliplatin and Capecitabine
Description:
Oxaliplatin130mg/m2 d1 iv；Capecitabine1000mg/m2 d1-d14
Arm group label:
ARM A*:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma
Arm group label:
ARM A:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma
Arm group label:
ARM D*:Colorectal cancer
Arm group label:
ARM D:Colorectal cancer
Intervention type:
Drug
Intervention name:
Anti-VEGF 15mg/kg
Description:
Bevacizumab 15mg/kg d1 iv q3w
Arm group label:
ARM B*: Liver adenocarcinoma
Arm group label:
ARM B: Liver adenocarcinoma
Intervention type:
Drug
Intervention name:
Anti-VEGF 7.5mg/kg
Description:
Bevacizumab 7.5mg/kg d1 iv q3w
Arm group label:
ARM D*:Colorectal cancer
Arm group label:
ARM D:Colorectal cancer
Intervention type:
Drug
Intervention name:
Gemcitabine and Cisplatin
Description:
Gemcitabine1000mg/m2 d1 d8 iv；Cisplatin 25mg/m2 d1 d8 iv q3w
Arm group label:
ARM C*: Malignant tumors of the biliary system
Arm group label:
ARM C: Malignant tumors of the biliary system
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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;
- ECOG score of 0-1;
- be able to accept the treatment regimen during the study;
- sign a written informed consent.
Exclusion Criteria:
- 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;
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhengjiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Ji Zhu
Phone:
13501978674
Email:
zhuji@zjcc.org.cn
Start date:
March 20, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06349044
