Hepatocellular Carcinoma
Conditions
Brief summary
The primary endpoint will be analyzed using descriptive statistics. In detail, the incidence and severity of treatment-related adverse events determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be described.
Detailed description
Efficacy will be evaluated by the number (percentage) of study participants achieving complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) as best radiological response evaluated according to mRECIST and RECIST v1.1 criteria. Objective response is defined as either complete or partial response, while disease control rate comprises complete/partial response as well as stable disease. Kaplan-Meier method will be used to calculate progression-free survival, Distribution of quality of life parameters will be assessed by plotting histograms. Baseline and follow-up values will be demonstrated as mean (+/- standard deviation) or median (IQR), as applicable. Changes of quality of life during the study period as assessed by EQ-5D-5L questionnaire will be evaluated using paired T-test or Wilcoxon signed rank test.
Interventions
DRUGAvastin 25 mg/ml concentrate for solution for infusion.
DRUGTecentriq 1 200 mg concentrate for solution for infusion
Sponsors
Medical University Of Vienna
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be analyzed using descriptive statistics. In detail, the incidence and severity of treatment-related adverse events determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be described. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy will be evaluated by the number (percentage) of study participants achieving complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) as best radiological response evaluated according to mRECIST and RECIST v1.1 criteria. Objective response is defined as either complete or partial response, while disease control rate comprises complete/partial response as well as stable disease. Kaplan-Meier method will be used to calculate progression-free survival, Distribution of quality of life parameters will be assessed by plotting histograms. Baseline and follow-up values will be demonstrated as mean (+/- standard deviation) or median (IQR), as applicable. Changes of quality of life during the study period as assessed by EQ-5D-5L questionnaire will be evaluated using paired T-test or Wilcoxon signed rank test. | — |
Countries
Austria
Outcome results
None listed