Unresectable Hepatocellular Carcinoma (HCC)
Conditions
Brief summary
ORR, calculated as the proportion of evaluable patients who have achieved, as BOR, confirmed CR or PR measured by investigator-assessed RECIST 1.1.
Detailed description
Overall safety profile characterized by type, severity (graded using National Cancer Institute CTCAE version 5.0), duration of the adverse events (AEs), laboratory, and electrocardiogram abnormalities, unacceptable toxicities, and relationship of the AEs to study treatment in the first and subsequent cycles of therapy, Duration of response (DOR) as measured by investigator-assessed RECIST 1.1, Progression-free survival (PFS), including landmark analyses, as measured by investigator-assessed RECIST 1.1, Overall survival, Pharmacokinetic parameters of NMS-01940153E and its main metabolite NMS-03593478 in plasma.
Interventions
Sponsors
Nerviano Medical Sciences S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR, calculated as the proportion of evaluable patients who have achieved, as BOR, confirmed CR or PR measured by investigator-assessed RECIST 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall safety profile characterized by type, severity (graded using National Cancer Institute CTCAE version 5.0), duration of the adverse events (AEs), laboratory, and electrocardiogram abnormalities, unacceptable toxicities, and relationship of the AEs to study treatment in the first and subsequent cycles of therapy, Duration of response (DOR) as measured by investigator-assessed RECIST 1.1, Progression-free survival (PFS), including landmark analyses, as measured by investigator-assessed RECIST 1.1, Overall survival, Pharmacokinetic parameters of NMS-01940153E and its main metabolite NMS-03593478 in plasma. | — |
Countries
Italy, Spain
Outcome results
None listed