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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 75

Lenalidomide Plus Targeted Therapy and Immunotherapy for Advanced 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

Run by Peking Union Medical College Hospital · NCT07639138 · Data updated 2026-11-12

This study tests whether adding lenalidomide to ongoing targeted therapy and immunotherapy helps people with advanced hepatocellular carcinoma who have progressed after at least two prior treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment32 (estimated)
SponsorPeking Union Medical College Hospital
Academic / other
Drugs / interventionsimmunotherapy
Locations1 site (Beijing, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China)
StatusRecruiting
StartedAugust 12, 2026
Main results expectedJune 30, 2028
Study endsJune 30, 2030
Registry record updatedSeptember 21, 2026
Trial IDNCT07639138 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18-75 with unresectable, locally advanced, or metastatic HCC who have benefited from a prior dual therapy (targeted therapy plus immunotherapy) and then progressed, with measurable disease and adequate organ function.

Probably not a fit

Patients who do not respond to lenalidomide add-on, have non-measurable disease, lack ongoing dual therapy, or have contraindications to lenalidomide or the background treatments may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm, investigator-initiated study in adults with unresectable or metastatic hepatocellular carcinoma who have progressed after at least two prior systemic therapies, including both a targeted therapy and an immune checkpoint inhibitor. Patients will continue their current targeted therapy and immunotherapy and receive add-on lenalidomide to assess safety and antitumor activity. The primary goals are to determine six-month progression-free survival and the rate of grade 3 or higher treatment-related adverse events. Secondary aims include overall survival and other efficacy endpoints, along with monitoring adverse events and tolerability. The study is conducted at one center in Beijing, China, led by investigator Shunda Du.

Why it matters

Potential benefit: If successful, this approach could offer a new option for patients who have exhausted standard therapies by potentially delaying disease progression and improving outcomes when lenalidomide is added to existing regimens.

How similar studies have gone: Prior phase II data suggest modest activity of lenalidomide in advanced HCC, but the added benefit in patients previously benefiting from dual therapy is not yet established.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Peking Union Medical College Hospital
    Beijing, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Hepatocellular Carcinoma (HCC) 119Peking Union Medical College Hospital 200
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.