Real-world Study of Lenalidomide After First-line Treatment Lenvatinib With PD-1 in Advanced HCC

NCT07184424 | Completed

• 1 other identifier: Dream-004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 combination with PD-1 inhibitors as part of routine clinical practice, and evaluating the efficacy of adding lenalidomide to their treatment regimen.

Conditions

HCC - Hepatocellular Carcinoma

Keywords

Lenalidomide; hepatocellular carcinoma

Outcome Measures

Primary Outcomes (2)

• 1 year PFS

  The time from enrollment in the clinical study until the first evidence of disease progression or death.Every two month, up to 1 year

  Following the administration of lenalidomide combination therapy, imaging examinations of lesion sites should be performed every two months to assess tumor status.

• OS

  From the start of treatment until death from any cause

  For one year or longer, until death

Study Arms (1)

Treatment group

EXPERIMENTAL

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).

Drug: lenalidomide

Interventions

lenalidomide DRUG

For patients with hepatocellular carcinoma who have experienced disease progression after receiving standard clinical treatment with lenvatinib in combination with PD-1 inhibitors, the addition of lenalidomide capsules to the three-drug combination therapy was followed by a 2-month follow-up liver imaging examination to observe changes in the target lesion and whether new lesions had developed in other areas.

Also known as: lenalidomide capsules

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• GONG LI, phD

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 19, 2025
• Study Start: May 24, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)