Hepatocellular Carcinoma
Conditions
Brief summary
Number (percentage) of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events., Number (percentage) of subjects discontinuing investigational product(s) due to toxicity., Changes from baseline in laboratory parameters (including liver and viral laboratory tests), electrocardiograms and vital signs.
Detailed description
Objective response rate (ORR), disease control rate (DCR), time to response (TTR), duration of response (DoR), time to progression (TTP), progression-free survival (PFS) based on investigator assessments and Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and overall survival (OS)., AEs, SAEs, discontinuation of investigational product(s) due to toxicity, and changes from baseline in laboratory parameters (including liver and viral laboratory tests), ECG, and vital signs in 3 distinct HCC populations: uninfected, HBV+, and HCV+., PD-L1 expression within the tumor microenvironment.
Interventions
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
DRUGBEVACIZUMAB
DRUGIMJUDO 20 mg/ml concentrate for solution for infusion.
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number (percentage) of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events., Number (percentage) of subjects discontinuing investigational product(s) due to toxicity., Changes from baseline in laboratory parameters (including liver and viral laboratory tests), electrocardiograms and vital signs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR), disease control rate (DCR), time to response (TTR), duration of response (DoR), time to progression (TTP), progression-free survival (PFS) based on investigator assessments and Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and overall survival (OS)., AEs, SAEs, discontinuation of investigational product(s) due to toxicity, and changes from baseline in laboratory parameters (including liver and viral laboratory tests), ECG, and vital signs in 3 distinct HCC populations: uninfected, HBV+, and HCV+., PD-L1 expression within the tumor microenvironment. | — |
Countries
Italy
Outcome results
None listed