JPRN-UMIN000046634
Not yet recruiting
未知
Resection of initially unresectable hepatocellular carcinoma with atezolizumab plus bevacizumab Additional study: Identification of biomarkers for predicting therapeutic effects and adverse events - RACB additional study
ational Center for Global Health and Medicine0 sites50 target enrollmentJanuary 15, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Center for Global Health and Medicine
- Enrollment
- 50
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\. Currently receiving oral or parenteral anticoagulants or thrombolytics within 10 days prior to enrollment. 2\. Have untreated or not adequately treated esophageal varices at high risk of bleeding, or a history of bleeding due to esophageal varices within 180 days prior to enrollment. 3\. Had thrombosis and/or embolism within 180 days before enrollment. 4\. Has undergone major surgical procedures within 28 days before enrollment. 5\. Has received systemic immunostimulatory agents within 180 days prior to enrollment. 6\. Has received systemic immunosuppressants within 14 days before enrollment. 7\.History and complications of autoimmune disease within 180 days prior to enrollment 8\. History of active double cancer or malignancy. 9\. Currently participating in another study of unapproved drugs or a study requiring intervention. 10\.Critical cardiovascular disease, unstable arrhythmia or unstable angina in the 90 days prior to enrollment. 11\.Pregnant, breastfeeding, positive in pregnancy test, women and men unwilling to contraceptive during the study period. 12\. Has clinically uncontrolled pleural effusion, pericardial effusion or ascites. 13\. Has complications of hepatic encephalopathy 14\. Uncontrollable hypertension, severe infection, hemodialysis 15\. Has a history of serious allergic or anaphylactic reactions to chimeric antibody, humanized antibody, or fusion protein. 16\.Hypersensitivity to either Chinese hamster ovary cell\-derived products or components of atezolizumab or bevacizumab products. 17\.Has a history of hemorrhagic disease, gastrointestinal hemorrhage or active hemoptysis. 18\. Difficult to ingest medication 19\.HIV\-positive 20\. Active pulmonary fibrosis or interstitial pneumonia 21\.Has received blood transfusions or G\-CSF products within 14 days prior to enrollment 22\. The attending physician judges that the patient is not suitable for participating in the study.
Outcomes
Primary Outcomes
Not specified
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