A PHASE III, MULTICENTER, RANDOMIZED, OPEN LABEL STUDY OF ATEZOLIZUMAB (ANTI PD-L1 ANTIBODY) PLUS BEVACIZUMAB VERSUS ACTIVE SURVEILLANCE AS ADJUVANT THERAPY IN PATIENTS WITH HEPATOCELLULAR CARCINOMA AT HIGH RISK OF RECURRENCE AFTER SURGICAL RESECTION OR ABLATION.
- Conditions
- -C220 Liver cell carcinomaLiver cell carcinomaC220
- Registration Number
- PER-026-19
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1
•For the 1st, 2nd, 5th, and 10th patients at each site: Medical Monitor approval prior to randomization in order to monitor adherence to key eligibility criteria
•Signed Informed Consent Form
•Age 18 years at time of signing Informed Consent Form
•Ability to comply with the study protocol, in the investigator´s judgment
•Participants with a first diagnosis of HCC who have undergone a curative resection or ablation (RFA or MVA only)
•Documented diagnosis of HCC that has been completely resected or ablated (RFA or MVA only).
•Absence of macrovascular (gross vascular) invasion and absence of extrahepatic spread, as confirmed by pre-curative procedure computed tomography (CT) or magnetic resonance imaging (MRI) scan of the chest, abdomen, and pelvis
•Full recovery from surgical resection or ablation within 4 weeks prior to randomization
•High risk for HCC recurrence after resection or ablation.
•For patients who received post-operative TACE: full recovery from the procedure within 4 weeks prior to randomization.
•For patients with resected HCC, availability of a representative baseline tumor tissue sample.
•Negative HIV test at screening
•Documented virology status of hepatitis.
See protocol for more detail.
•Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
•Recurrent HCC prior to randomization
•Evidence of residual, recurrent, or metastatic disease at randomization
•Clinically significant ascites
•History of hepatic encephalopathy
•Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization
•Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic .
•History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
•Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to Day 1 of Cycle 1, unstable arrhythmia, or unstable angina
•History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival [OS] rate 90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
•Active tuberculosis
•Severe infection within 4 weeks prior to Day 1 of Cycle 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
•Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1.
•Prior allogeneic stem cell or solid organ transplantation
•On the waiting list for liver transplantation
•Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
•Pregnant or breastfeeding, or intending to become pregnant.
•Co-infection with HBV and HCV
See protocol for more detail.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method