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Condition / disease
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Status: Recruiting

Lenalidomide Plus Targeted Therapy and Immunotherapy for Refractory HCC

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).

Participants needed: 32
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Shunda DuUpdated: Jun 10, 2026Locations: 1
Eligibility criteria

1. Primary resistance to the most recent targeted therapy plus ICI regimen, defi...