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NCT07184424Completed

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 · Last updated 19 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
24 (actual)
First submitted
9 Sept 2025
Start date
24 May 2023
Primary completion date
30 Apr 2025
Lead sponsor
Beijing Tsinghua Chang Gung Hospital
NCT number
NCT07184424

What you commit to

  • Study type: Interventional
  • Participants enrolled: 24
  • From 24 May 2023 to the primary completion date, 30 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;
  • Patients who have previously used pomalidomide or thalidomide;
  • Patients who have previously received CTLA-4 in combination with PD-1/PD-L1 inhibitors;

Other illness

  • Active infection requiring systemic treatment;
  • Patients with myocardial ischemia or myocardial infarction graded CTCAE grade II or higher, or uncontrolled arrhythmia;

Lab values

  • CTCAE grading Platelet count < 50 × 10⁹/L or neutrophil count < 1 × 10⁹/L

Other

  • Fibrous plate layer or sarcomatoid HCC or mixed type HCC-ICC;
  • Hepatic encephalopathy in the past 6 months, or obvious ascites at enrollment;
  • Pregnant or breastfeeding women;
  • Other situations deemed unsuitable for participation in this trial by researchers;

Who the study is looking for

  • 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;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Beijing Tsinghua Changgung Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.