A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular
- Conditions
- Carcinoma, Hepatocellular
- Registration Number
- JPRN-jRCT2080223794
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 26
(1)Participants must have confirmed diagnosis of hepatocellular carcinoma (HCC) with any of the following criteria:
- Histologically or cytologically confirmed diagnosis of HCC, excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors
- Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases criteria, including cirrhosis of any etiology and/or chronic hepatitis B or C infection
(2)Part 1: HCC for which no other appropriate therapy is available; Part 2: No prior systemic therapy for advanced/unresectable HCC
(3)Participants categorized to stage B (not applicable for transarterial chemoembolization), or stage C based on Barcelona Clinic Liver Cancer staging system
(4)Child-Pugh score A
(5) Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 to 1
(6) Age >=20 years at the time of informed consent
(1)Active co-infection with hepatitis B and hepatitis C
(2)Participants with any active, known, or suspected autoimmune disease
(3)Participants being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study
(4)Females who are breastfeeding or pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>safety<br>Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs)<br>Part 1 and Part 2: Number of Participants with Any Serious and/or Non-serious Adverse Event
- Secondary Outcome Measures
Name Time Method other<br>-