Clinical trial · Interventional
Real-world Study of Lenalidomide After First-line Treatment Lenvatinib With PD-1 in Advanced HCC
A Real-world Study on the Addition of Lenalidomide to Reverse Resistance After First-line Treatment Lenvatinib Combined With PD-1 Therapy in Advanced Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 combination with PD-1 inhibitors as part of routine clinical practice, and evaluating the efficacy of adding lenalidomide to their treatment regimen.
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 |
|---|---|---|---|
| HCC - Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- In clinical practice, for patients with hepatocellular carcinoma (HCC) who have received targeted therapy combined with immune checkpoint inhibitors as first-line treatment and subsequently experienced disease progression, lenalidomide capsules are incorporated into the regimen (administered orally on days 1-21, followed by a 7-day treatment-free interval, repeating every 28 days per cycle).
- interventionNames
- Drug: lenalidomide
Primary outcomes (2)
- measure
- 1 year PFS
- timeFrame
- Following the administration of lenalidomide combination therapy, imaging examinations of lesion sites should be performed every two months to assess tumor status.
- description
- The time from enrollment in the clinical study until the first evidence of disease progression or death.Every two month, up to 1 year
- measure
- OS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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;
References
Publications (0)
Data not yet available