Hepatocellular Carcinoma
Conditions
Brief summary
OS, defined as the time between the date of randomization and the date of death (by any cause).
Detailed description
ORR, defined as the percentage of participants whose BOR is either a confirmed CR or PR., DOR, defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression or death due to any cause, whichever occurs first, TTSD, defined as the time from randomization until a clinically meaningful decline in the HCS subscale score of the FACT-Hep., PFS, defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first., TTP, defined as the time from randomization to the first documented disease progression.
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGSorafenib 200mg Film-Coated Tablets
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
DRUGLENVATINIB
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS, defined as the time between the date of randomization and the date of death (by any cause). | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR, defined as the percentage of participants whose BOR is either a confirmed CR or PR., DOR, defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression or death due to any cause, whichever occurs first, TTSD, defined as the time from randomization until a clinically meaningful decline in the HCS subscale score of the FACT-Hep., PFS, defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first., TTP, defined as the time from randomization to the first documented disease progression. | — |
Countries
Austria, Belgium, France, Germany, Italy, Poland, Romania, Spain
Outcome results
None listed