Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC

April 28, 2025 updated by: Second Affiliated Hospital of Guangzhou Medical University

Lenvatinib Combined With Yttrium-90 Selective Internal Radiation Therapy (SIRT) Versus Lenvatinib Alone in TACE-Refractory Hepatocellular Carcinoma: A Prospective Non-Randomized Controlled Study

This study is conducted to evaluate the efficacy and safety of lenvatinib plus SIRT (LEN+SIRT) compared with lenvatinib (LEN) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, non-randomized controlled trial to evaluate the efficacy and safety of LEN+SIRT versus LEN alone for patients with TACE-refractory HCC.

78 patients (39 in each arm) with TACE-refractory HCC will be enrolled in this study. The patients will receive either LEN+SIRT or LEN.

Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be administered to the patients and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the LEN+SIRT arm, lenvatinib will be started at 3-7 days after SIRT.

The primary end point of this study is objective response rate (ORR). The secondary endpoints are disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and adverse events (AEs).

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mingyue Cai, Dr.
  • Phone Number: +86-20-34156205
  • Email: cai020@yeah.net

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • Recruiting
        • The second Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kangshun Zhu, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pathologically confirmed or clinically diagnosed HCC
  • Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)
  • Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
  • At least one measurable intrahepatic target lesion
  • Child-Pugh class A/B
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Tumor extent <70% liver occupation
  • Candidates for SIRT must be confirmed suitable for SIRT after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
  • Adequate organ and hematologic function with platelet count ≥50×10^9/L, leukocyte >3.0×10^9/L, Neutrophil count ≥1.5×10^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, albumin ≥28 g/L, total bilirubin ≤3× ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Extrahepatic metastasis
  • Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
  • Vena cava invasion
  • Patients who received prior hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy, for HCC
  • History of organ and cell transplantation
  • History of esophageal or gastric variceal bleeding
  • History of hepatic encephalopathy
  • History of other malignancies
  • Human immunodeficiency virus infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Len+SIRT
Lenvatinib plus SIRT
Combination product: Lenvatinib plus SIRT
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. QD will be started at 3-7 days after the first SIRT.
Active Comparator: LEN
Lenvatinib alone
Drug: Lenvatinib
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. QD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 3 years
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: 3 years
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST.
3 years
Progression free survival (PFS)
Time Frame: 3 years
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
3 years
Time to response (TTR)
Time Frame: 3 years
The time from treatment initiation to first tumour remission (mRECIST)
3 years
Duration of response (DOR)
Time Frame: 3 years.
Time from first tumor response to first disease progression (mRECIST) or death from any cause (whichever occurs first)
3 years.
Overall survival (OS)
Time Frame: 4 years.
The time from date of treatment initiation to death due to any cause
4 years.
Adverse Events (AEs)
Time Frame: 3 years.
Number of patients with AEs assessed by NCI CTCAE v5.0.
3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Investigators

  • Study Chair: Mingyue Cai, Dr., Second Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIIR-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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