C220 Liver cell carcinoma Liver cell carcinoma
Conditions
Interventions
None listed
Sponsors
F. HOFFMANN-LA ROCHE LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free surviva (RFS) after randomization, defined as the time from randomization to the first documentad occurrence of local, regional, or metastatic HCC as determined by an IRF, or deathfrom any cause (vrhicheveroccursfirst). NAME OF THE RESULT: Recurrence-free survival (RFS) after randomization. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study.;* Incidence and severityof adverse events, with severity determined accordtng to NCI CTCAE vS.O * Change from baseline in targeted vital signs * Change from baseline in targeted clinical laboratory test results. NAME OF THE RESULT: * Incidence and severltyof adverse events, using NCI CTCAE vS.O * Change In targeted vital signs * Change in targeted cllnical laboratory test results. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-free surviva (RFS) after randomization, defined as the time from randomization to the first documentad occurrence of local, regional, or metastatic HCC as determined by an IRF, or deathfrom any cause (vrhicheveroccursfirst). NAME OF THE RESULT: Recurrence-free survival (RFS) after randomization. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study.;* Incidence and severityof adverse events, with severity determined accordtng to NCI CTCAE vS.O * Change from baseline in targeted vital signs * Change from baseline in targeted clinical laboratory test results. NAME OF THE RESULT: * Incidence and severltyof adverse events, using NCI CTCAE vS.O * Change In targeted vital signs * Change in targeted cllnical laboratory test results. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study.;* OS after randomization, defined as the time from randomization to death from any cause * RF S after randomization as determined by the Investigator * TTR after randomization, deflned as the time from randomization to first documentad occurrence of local, regional, or metastatic HCC, as determined by the Investigator and by an IRF * OS rate at 24 months and 36 months, defined as the proportion of patients who have not experienced death from any cause at 24 and 36 months after randomization, respectively * Time to EHS or macrovascular invasion after randomization, defined as the time from randomization to the flrst appearance of EHS or macrovascular invasion, as determined by the Investigator and by an IRF * RFS after randomization as determined by the Investigator and by an IRF, among patients in the PD-Lliaiigh subgroup NAME OF THE RESULT: * Overall surviva (OS) after randomization. * Recurrence-free survival (RFS) after randomization. * Time to recurence (TTR) after randomization. investigator and by an IRF * OS rate at 24 months and 36 months | — |
Countries
Argentina, Australia, Austria, Belgium, China, France, Germany, Italy, Peru, Poland, Russian Federation, Spain, Thailand, United Kindgdom, United States
Outcome results
None listed