OncoMatch/Clinical Trials/NCT07639138
Lenalidomide Plus Targeted Therapy and Immunotherapy for Refractory HCC
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
Is NCT07639138 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Lenalidomide and Targeted Therapy for hepatocellular carcinoma (hcc).
Treatment: Lenalidomide · Targeted Therapy · Immune Checkpoint Inhibitors — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: systemic antitumor therapy
Prior receipt of at least two lines of systemic antitumor therapy
Must have received: targeted therapy
previous exposure to both targeted therapy and immune checkpoint inhibitors (ICIs)
Must have received: immune checkpoint inhibitor
previous exposure to both targeted therapy and immune checkpoint inhibitors (ICIs)
Cannot have received: lenalidomide (lenalidomide)
Prior exposure to lenalidomide or a history of severe hypersensitivity to lenalidomide or thalidomide
Lab requirements
Blood counts
ANC ≥1.0 × 10^9/L, platelet count ≥60 × 10^9/L, hemoglobin ≥80 g/L
Kidney function
creatinine clearance (CrCl) ≥30 mL/min
Liver function
ALT and AST ≤5 × ULN; total bilirubin ≤3 mg/dL
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07639138 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior lenalidomide disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages