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Lenalidomide Plus Targeted Therapy and Immunotherapy for Refractory HCC
Sponsor: Shunda Du
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).
Official title: Safety and Efficacy of Lenalidomide Combined With Targeted Therapy and Immunotherapy in Patients With Advanced Hepatocellular Carcinoma Resistant to Multiple Prior Lines of Treatment: A Single-Center, Single-Arm, Prospective Exploratory Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2026-08-12
Completion Date
2030-06-30
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
Lenalidomide
Lenalidomide administered orally in combination with ongoing targeted therapy and immunotherapy until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
Targeted Therapy
Continuation of the most recent targeted therapy regimen that previously provided clinical benefit before disease progression.
Immune Checkpoint Inhibitors
Continuation of the most recent immune checkpoint inhibitor regimen that previously provided clinical benefit before disease progression.
Locations (1)
Peking Union Medical College Hospital
Beijing, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China, China