RecruitingPhase 2NCT07639138

Lenalidomide Plus Targeted Therapy and Immunotherapy for Refractory HCC

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


Sponsor

Shunda Du

Enrollment

32 participants

Start Date

Aug 12, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Immune Checkpoint Inhibitors, a drug called Lenalidomide, and others for people with hepatocellular carcinoma (hcc). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenalidomide

Lenalidomide administered orally in combination with ongoing targeted therapy and immunotherapy until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.

DRUGTargeted Therapy

Continuation of the most recent targeted therapy regimen that previously provided clinical benefit before disease progression.

DRUGImmune 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

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NCT07639138


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