Study Stopped
The sponsor withdrawed the sponsorship to the study.
Safety and Efficacy of Lenvatinib in Subjects With HCC Progression After First Line Treatment With Checkpoint Inhibitors
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
1 other identifier
observational
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedStudy Start
First participant enrolled
July 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedOctober 5, 2023
October 1, 2023
1.2 years
June 9, 2020
October 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Adverse Events
12 month
Study Arms (2)
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.
Interventions
Eligibility Criteria
Subjects with HCC progression after first line treatment with checkpoint inhibitors
You may qualify if:
- 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
You may not qualify if:
- Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
- Prior TKI treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Humanity & Health Medical Group Limitedlead
- Beijing 302 Hospitalcollaborator
- Kindai University Faculty of Medicinecollaborator
Study Sites (1)
Humanity & Health Clinical Trial Centre
Hong Kong, Hong Kong SAR, Hong Kong
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2020
First Posted
June 11, 2020
Study Start
July 2, 2022
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
October 5, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share