Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immune Checkpoint Inhibitors | Drug | — | UNRESOLVED |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Targeted Therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide Combination Therapy
- description
- Patients with advanced hepatocellular carcinoma who have progressed after multiple lines of systemic therapy will continue their current targeted therapy and immune checkpoint inhibitor regimen and receive lenalidomide as add-on treatment.
- interventionNames
- Drug: Lenalidomide
- Drug: Targeted Therapy
- Drug: Immune Checkpoint Inhibitors
Primary outcomes (2)
- measure
- Incidence of Grade ≥3 Treatment-Related Adverse Events
- timeFrame
- From treatment initiation until 30 days after treatment discontinuation
- description
- 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.
- measure
- 6-Month Progression-Free Survival Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: -1. Age ≥18 years and ≤75 years; 2. Clinically or pathologically diagnosed hepatocellular carcinoma (HCC); 3. Unresectable, locally advanced, or metastatic HCC; 4. Prior receipt of at least two lines of systemic antitumor therapy, with previous exposure to both targeted therapy and immune checkpoint inhibitors (ICIs). No restrictions are imposed on the specific targeted agents or ICIs used in combination with lenalidomide; 5. Demonstrated clinical benefit from the most recent line of dual-agent therapy, defined as complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 4 weeks, followed by radiographic progression or clinical treatment failure; 6. At least one measurable lesion according to RECIST version 1.1; 7. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1; 8. Adequate organ function, defined as: absolute neutrophil count (ANC) ≥1.0 × 10\^9/L, platelet count ≥60 × 10\^9/L, hemoglobin ≥80 g/L, creatinine clearance (CrCl) ≥30 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × upper limit of normal (ULN), and total bilirubin ≤3 mg/dL; 9. Virological status, including hepatitis B virus (HBV) and hepatitis C virus (HCV), must be assessed. Patients who are HBsAg-positive or have a history of HBV infection must undergo hepatology evaluation and receive antiviral prophylaxis when indicated. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available