Hepatocellular Carcinoma
Conditions
Interventions
None listed
Sponsors
National Center for Global Health and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with hepatocellular carcinoma and no prior medical therapy (sorafenib, lenvatinib and immunotherapy) for hepatocellular carcinoma 2.Have at least one target lesion based on RECISTver1.1 criteria 3.Age 20 years or older 4.Eastern Cooperative Oncology Group Performance Status (PS) 0-1 5.Adequate organ function If more than one test result is present within the study period, the most recent one to enrollment should be employed, and no blood transfusion and administration of hematopoietic factor products have been performed within 30 days before the test day for measurement prior to enrollment. WBC >=3000/mm3, neutrophil count >=1500/mm3, Hb >=8.5g/dL, platelet count >=60,000/mm3, total bilirubin <=3.0 mg/dL, serum albumin >=2.8g/dL, AST (GOT), ALT (GPT) <=5 times the upper limit of each medical institution (excluding cases associated with cancer) Serum creatinine <=1.5 times the upper limit of each medical institution Urine protein<= 2+ Urine protein/creatinine ratio <2.0 at any time when urine protein is >=3+ (urine protein < 2.0g in case of 24-hour urine collection). 6.Child Pugh score of 5-6 within 14 days prior to enrollment 7.No other active malignancies 8.A patient's written informed consent (IC) has been obtained after sufficient explanation of study given to the patient. 9. Hepatocellular carcinoma tumor conditions are classified as A, B, C, D, or E. *1 Unresectable hepatocellular carcinoma.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum cytokine, PD-L1, PD-1, CTLA-4, Immunological evaluation of surgical specimens | — |
Secondary
| Measure | Time frame |
|---|---|
| Therapeutic effect on the imaging study, Resectability, Progression-free survival, Overall survival, Adverse event, immune-related Adverse Events (irAE) | — |
Countries
Japan
Contacts
Public ContactKyoji Ito
National Center for Global Health and Medicine Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Outcome results
None listed