Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The sponsor withdrawed the sponsorship to the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing 302 Hospital | OTHER |
| Kindai University Faculty of Medicine | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenvatinib | Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by lenvatinib. |
| |
| Non-Lenvatinib | Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by non-lenvatinib. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib | Drug | Prescribed by physician. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (RR) | 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 | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 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. | 12 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects with HCC progression after first line treatment with checkpoint inhibitors
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanity & Health Clinical Trial Centre | Hong Kong | Hong Kong SAR | Hong Kong |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C531958 | lenvatinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A blood sample for alpha-fetoprotein (AFP) assessment will be obtained by local laboratory every 4 weeks to correlate with each radiographic disease assessment visit.
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |