Health Trials

Lenalidomide Plus Targeted Therapy and Immunotherapy for Refractory HCC

ConditionHepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShunda Du

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

1. Primary resistance to the most recent targeted therapy plus ICI regimen, defined as unequivocal disease progression within 6 weeks or 2 treatment cycles without any evidence of prior clinical benefit; 2. Prior exposure to lenalidomide or a history of severe hypersensitivity to lenalidomide or thalidomide; 3. Explosive disease progression, or situations in which continuation of the existing treatment backbone is deemed clinically unreasonable by the investigator; 4. Uncontrolled ascites, hepatic encephalopathy, or active gastrointestinal bleeding; active severe infections, including uncontrolled HBV replication, tuberculosis, severe pulmonary infection, or other serious infections; 5. Persistent treatment-related toxicities of grade ≥2 that have not recovered to baseline or acceptable levels at study entry; 6. Creatinine clearance (CrCl) <30 mL/min; 7. Pregnancy, breastfeeding, or inability/unwillingness to comply with contraceptive requirements.

Trial design

Design model

Single group

Treatments tested in this trial

  • Lenalidomide

    Drug

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

  • Targeted Therapy

    Drug

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

  • Immune Checkpoint Inhibitors

    Drug

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

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Lenalidomide Combination TherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of Grade ≥3 Treatment-Related Adverse Events

Incidence of treatment-related adverse events of grade 3 or higher, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame
From treatment initiation until 30 days after treatment discontinuation
2

6-Month Progression-Free Survival Rate

Proportion of patients who remain alive without radiographic disease progression 6 months after treatment initiation, as assessed according to RECIST version 1.1.

Time frame
6 months after treatment initiation

Secondary outcomes

1

Objective Response Rate

Time frame
Up to 24 months
2

Disease Control Rate

Time frame
Up to 24 months
3

Duration of Response

Time frame
Up to 24 months
4

Overall Survival

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shunda Du

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution

Source ClinicalTrials.gov
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