Safety and Efficacy of Lenvatinib in Subjects With HCC Progression After First Line Treatment With Checkpoint Inhibitors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Lenvatinib Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by lenvatinib. |
Drug: Lenvatinib
Prescribed by physician.
Other Names:
|
| Non-Lenvatinib Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by non-lenvatinib. |
Outcome Measures
Primary Outcome Measures
- Response rate (RR) [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 Outcome Measures
- Adverse Events [12 month]
An adverse event (AE) refers to any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, but which does not necessarily have a causal relationship with this treatment. Number and classification of participants with treatment-related adverse events as assessed by CTCAE v4.0 were recorded.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Humanity & Health Clinical Trial Centre | Hong Kong | Hong Kong SAR | Hong Kong |
Sponsors and Collaborators
- Humanity & Health Medical Group Limited
- Beijing 302 Hospital
- Kindai University Faculty of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VICI-6