An Observational Study to Evaluate the Safety and Efficacy of Lenvatinib in HCC Subjects Who Have Progressive Disease After First Line Treatment With Checkpoint Inhibitors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Response rate (RR)
Study Overview
Brief Summary
The objective of this study is to evaluate the efficacy of lenvatinib in HCC subjects who have progressive disease after first line treatment with checkpoint inhibitors.
Approximately 20 subjects will be enrollment to evaluate the efficacy and safety of lenvatinib.
CT/MRI assessments will be made at end of first line treatment with checkpoint inhibitors, and every 8-12 weeks thereafter. Disease status will be determined at the site (ie. Investigator and/or radiologist) using RECIST version 1.1.
The primary efficacy endpoint is response rate (RR) defined as proportion of subjects with SD/PR/CR per RECIST 1.1.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years old on the day of consent
- •Capable of understanding and complying with the protocol requirements and signed informed consent
- •Documented histological or cytological diagnosis of HCC
- •HCC progression after first line treatment with checkpoint inhibitors per RECIST 1.1
Exclusion Criteria
- •Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
- •Prior TKI treatment
Arms & Interventions
Lenvatinib
Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by lenvatinib.
Intervention: Lenvatinib (Drug)
Outcomes
Primary Outcomes
Response rate (RR)
Time Frame: 12 month
It is the sum of the proportion of stable disease (SD), complete response (CR) and partial response(PR) per RECIST 1.1. That is, RR = SD + CR + PR
Secondary Outcomes
- Adverse Events(12 month)