Status:
COMPLETED
Real-world Study of Lenalidomide After First-line Treatment Lenvatinib With PD-1 in Advanced HCC
Lead Sponsor:
Beijing Tsinghua Chang Gung Hospital
Conditions:
HCC - Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a real-world, single-arm, observational study primarily collecting data on patients with hepatocellular carcinoma who experienced disease progression after receiving lenvatinib in combin...
Detailed Description
This study is a real-world, single-arm, observational study primarily collecting data on patients with hepatocellular carcinoma who experienced disease progression after receiving lenvatinib in combin...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old;
- Patients with hepatocellular carcinoma who previously received lenvatinib and PD-1 inhibitors and whose tumors progressed on imaging (enhanced MRI, enhanced CT, or PET-CT) were treated with lenalidomide；
- Expected survival period exceeding 3 months;
- Patients with a history of other malignant tumors who have been disease-free for more than 2 years after initial treatment (such as non-melanoma skin cancer or cervical carcinoma in situ);
- Participants of childbearing age agreed to use contraception during the study period;
Exclusion
- Fibrous plate layer or sarcomatoid HCC or mixed type HCC-ICC;
- Currently participating in and receiving other experimental treatments;
- Previously underwent solid organ transplantation, diagnosed with immunodeficiency;
- Bleeding from esophageal or gastric varices within 3 months prior to enrollment;
- Hepatic encephalopathy in the past 6 months, or obvious ascites at enrollment;
- Active infection requiring systemic treatment;
- CTCAE grading Platelet count \< 50 × 10⁹/L or neutrophil count \< 1 × 10⁹/L
- Pregnant or breastfeeding women;
- Patients with myocardial ischemia or myocardial infarction graded CTCAE grade II or higher, or uncontrolled arrhythmia;
- Patients who have previously used pomalidomide or thalidomide;
- Patients who have previously received CTLA-4 in combination with PD-1/PD-L1 inhibitors;
- Other situations deemed unsuitable for participation in this trial by researchers;
Key Trial Info
Start Date :
May 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07184424
Start Date
May 24 2023
End Date
April 30 2025
Last Update
September 19 2025
Active Locations (1)
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1
Beijing Tsinghua Changgung Hospital
Beijing, China