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Lenalidomide Plus Targeted Therapy and Immunotherapy for Refractory HCC

NCT07639138 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-06-10

No results posted yet for this study

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).

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DRUG

Lenalidomide

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

DRUG

Targeted Therapy

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

DRUG

Immune Checkpoint Inhibitors

Continuation of the most recent immune checkpoint inhibitor regimen that previously provided clinical benefit before disease progression.

Sponsors & Collaborators

  • Shunda Du

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-10
Primary Completion
2028-06-30
Completion
2030-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07639138 on ClinicalTrials.gov