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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128051
Enrollment
Unknown
Registered
2026-07-13
Start date
2026-07-14
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Hepatocellular Carcinoma

Interventions

Experimental group:Lenalidomide combined with targeted therapy and immunotherapy

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years and = 1.0×10^9/L, platelets >= 60×10^9/L, Hb >= 80 g/L, CrCl >= 30 mL/min, ALT/AST <= 5×ULN, total bilirubin <= 3 mg/dL; 9. The viral status of HBV, HCV, etc. has been evaluated; HBsAg positive or those with previous HBV infection must undergo liver disease specialist assessment and receive antiviral prophylaxis as needed.

Exclusion criteria

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;

Design outcomes

Primary

MeasureTime frame
6-month PFS rate;Incidence of grade >=3 treatment-related adverse events (TRAEs);

Countries

China

Contacts

Public ContactShunda Du

Peking Union Medical College Hospital

dushd@pumch.cn+86 10 6915 2830

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026