Clinical Trial

Lenalidomide Plus Targeted Therapy and Immunotherapy for Refractory HCC

Recruiting Phase 2
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Summary
This is a prospective, single-arm, investigator-initiated clinical study designed to evaluate the safety and efficacy of lenalidomide in combination with targeted therapy and immunotherapy in patients with advanced hepatocellular carcinoma (HCC) who have experienced disease progression after multiple lines of systemic treatment. Eligible patients must have received at least two prior lines of systemic therapy, including both targeted therapy and immune checkpoint inhibitor (ICI)-based treatment, and must have previously achieved clinical benefit from their most recent treatment regimen before developing disease progression. Participants will continue their current targeted therapy and immunotherapy regimen and receive lenalidomide as add-on treatment. The study will assess antitumor activity, survival outcomes, and treatment-related adverse events. The primary objectives are to evaluate 6-month progression-free survival (PFS) and the incidence of grade ≥3 treatment-related adverse events (TRAEs). Secondary objectives include objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and overall survival (OS).
Trial Details
NCT Number NCT07639138
Lead Sponsor Shunda Du
Conditions Hepatocellular Carcinoma (HCC)
Enrollment 32 participants
Start Date 2026-06-10
Primary Completion 2028-06-30 (estimated)
Study Completion 2030-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-10