Safety and Efficacy of Lenvatinib in Subjects With HCC Progression After First Line Treatment With Checkpoint Inhibitors
NCT ID: NCT04428437
Last Updated: 2023-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
17 participants
OBSERVATIONAL
2022-07-02
2023-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lenvatinib
Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by lenvatinib.
Lenvatinib
Prescribed by physician.
Non-Lenvatinib
Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by non-lenvatinib.
No interventions assigned to this group
Interventions
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Lenvatinib
Prescribed by physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Capable of understanding and complying with the protocol requirements and signed informed consent
3. Documented histological or cytological diagnosis of HCC
4. HCC progression after first line treatment with checkpoint inhibitors per RECIST 1.1
Exclusion Criteria
2. Prior TKI treatment
18 Years
ALL
No
Sponsors
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Beijing 302 Hospital
OTHER
Kindai University Faculty of Medicine
UNKNOWN
Humanity & Health Medical Group Limited
OTHER
Responsible Party
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Locations
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Humanity & Health Clinical Trial Centre
Hong Kong, Hong Kong SAR, Hong Kong
Countries
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Other Identifiers
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VICI-6
Identifier Type: -
Identifier Source: org_study_id
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