An observational study in Hepatocellular Carcinoma, sponsored by Humanity & Health Medical Group Limited. Terminated at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by Humanity & Health Medical Group Limited · Observational
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.
3,251 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's enrollment of 17 is below the median of 200 across 769 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Humanity & Health Medical Group Limited is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects with HCC progression after first line treatment with checkpoint inhibitors
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by lenvatinib.
Drug: Lenvatinib
Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by non-lenvatinib.
Prescribed by physician.
Also known as: Lenvima, E7080
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
Time frame: 12 month
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.
Time frame: 12 month
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Sep 2023, 14 months.
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This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Humanity & Health Medical Group Limited