Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The sponsor withdrawed the sponsorship to the study.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Lenvatinib
- description
- Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by lenvatinib.
- interventionNames
- Drug: Lenvatinib
- label
- Non-Lenvatinib
- description
- Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by non-lenvatinib.
Primary outcomes (1)
- measure
- Response rate (RR)
- timeFrame
- 12 month
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old on the day of consent 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: 1. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma 2. Prior TKI treatment
References
Publications (0)
Data not yet available