Clinical trial · Interventional
Lenalidomide as Second-line Treatment for Advanced Hepatocellular Carcinoma
Lenalidomide as Second-line Treatment for Advanced Hepatocellular Carcinoma (HCC): a Phase II Clinical Trial
NCT01545804CI-TRIAL-00025875completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-arm, open-label phase II trial. Eligible patients must have histological or clinical diagnosis of Hepatocellular Carcinoma (HCC), advanced tumors that are not amenable to loco-regional therapy, documented progression with or intolerance to sorafenib-based treatment or other anti-angiogenic therapy as first-line therapy for advanced HCC.
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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide
- interventionNames
- Drug: Lenalidomide
Primary outcomes (1)
- measure
- disease stabilization
- timeFrame
- 8 weeks until tumor progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically diagnosed HCC, OR clinically diagnosed HCC * Documented progression with or intolerance to first-line molecular targeted therapy as first-line therapy for advanced HCC. * Acceptable first-line molecular targeted therapies include (1) sorafenib monotherapy and sorafenib-based combination; (2) anti-angiogenic therapy including brivanib, linifanib, pazopanib, bevacizumab, dovitinib (TKI258), and vargatef (BIBF1120). * For patients who receive first-line sorafenib monotherapy or sorafenib-based combination, patients must have received at least 14 days of sorafenib treatment with the lowest dosage of 400 mg per day. * At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure. * ECOG performance status 0 or 1. * Child-Pugh class A liver function. Exclusion Criteria: * Receiving concurrent anti-cancer therapy for HCC, which includes local therapy, chemotherapy, or other experimental therapy. * Local treatment including radiotherapy (except palliative radiotherapy), percutaneous ethanol injection, radiofrequency ablation, transarterial embolization, or cryotherapy administered within 4 weeks prior to enrollment. * History of HCC tumor rupture. * Presence of brain or leptomeningeal metastases. * Esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding. * History of upper gastrointestinal bleeding within 1 year.
References
Publications (1)
- DERIVEDShao YY, Chen BB, Ou DL, Lin ZZ, Hsu CH, Wang MJ, Cheng AL, Hsu C. Lenalidomide as second-line therapy for advanced hepatocellular carcinoma: exploration of biomarkers for treatment efficacy. Aliment Pharmacol Ther. 2017 Oct;46(8):722-730. doi: 10.1111/apt.14270. Epub 2017 Aug 17. PMID 28815645