Lenalidomide as Second-line Treatment for Advanced Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Lenalidomide; Thalidomide

Criteria

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.