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TACE With Lenvatinib Versus Lenvatinib Alone in in First-line Treatment of Advanced HCC

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03905967
Collaborator
(none)
336
Enrollment
1
Location
2
Arms
48
Anticipated Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is is an open label, multicenter, randomized controlled phase 3 clinical trial. The purpose is to compare the efficacy and safety of lenvatinib plus TACE with lenvatinib alone for advanced HCC patients.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
336 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Transarterial Chemoembolization With Lenvatinib Versus Lenvatinib Alone in First-line Treatment of Advanced Hepatocellular Carcinoma: a Phase III, Multicenter, Randomized Controlled Trial
Actual Study Start Date :
Jun 16, 2019
Anticipated Primary Completion Date :
Apr 15, 2023
Anticipated Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lenvatinib + TACE

Patients in Lenvatinib + TACE group will take oral lenvatinib within 3 days of randomization and receive TACE 1 day after oral administration of lenvatinib.

Procedure: TACE
TACE will be performed one day after oral administration of lenvatinib. TACE with either cTACE or DEB-TACE can be used, depending on the condition of each center.

Drug: Lenvatinib
Lenvatinib will be taken within 3 days of randomization (dose: 8 mg qd for patients <60kg, and 12 mg qd for patients >60kg)
Active Comparator: Lenvatinib

Lenvatinib alone

Drug: Lenvatinib
Lenvatinib will be taken within 3 days of randomization (dose: 8 mg qd for patients <60kg, and 12 mg qd for patients >60kg)

Outcome Measures

Primary Outcome Measures

  1. Overall survival [two years]

    Defined as the time from randomization to death for any cause.

Secondary Outcome Measures

  1. Time to progression [two years]

    Defined as the time from randomization to disease progression.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age 18-75 years old;

  2. Patients with primary advanced HCC (in accordance with AASLD2018 guidelines for the diagnosis of HCC), without any previous treatment;

  3. There is at least one measurable lesion in the liver according to mRECIST criteria, single tumor ≤ 10.0 cm or multiple tumors and tumor burden ≤50% , with portal vein tumor embolus or with extrahepatic metastasis;

  4. ECOG score 0-1;

  5. Child-Pugh class A;

  6. Expected survival time ≥ 3 months;

  7. Blood, liver and kidney function meet the following conditions: Neutrophil count ≥ 1.5 × 10 9 /L; Platelet count ≥ 60 × 10 9 /L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Bilirubin ≤ 50 umol/L; AST, ALT ≤ 5 times the upper limit of normal, ALP ≤ 4 times the upper limit of normal; Prolongation of prothrombin time not to exceed the upper limit of normal by 6 seconds; Creatinine ≤ 1.5 times the upper limit of normal

Exclusion Criteria:

  1. Preoperative imaging examination revealed diffuse intrahepatic lesions or invasion, inferior vena cava or primary branch bile duct;

  2. Previous history of hepatic encephalopathy, refractory ascites or gastric esophageal varices;

  3. There are contraindications to TACE treatment, such as portosystemic shunt, liver flow ablation, significant atherosclerosis;

  4. Brain metastases;

  5. Hypersensitivity to intravenous contrast agents;

  6. Pregnant or lactating women or subjects with family planning within two years;

  7. With HIV, syphilis infection;

  8. Accompanied by other malignant tumors or suffering from other malignancies within 5 years before enrollment;

  9. Allogeneic organ transplant recipients;

  10. Severe dysfunction of heart and kidney or other organs;

  11. Active severe infection > grade 2 (NCI-CTC version 4);

  12. Suffering from mental and psychological diseases may affect informed consent;

  13. Unable to take oral medication;

  14. Participated in other drug clinical trials within 12 months before enrollment;

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong China 510080

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Principal Investigator: Ming Kuang, PhD, First Affiliated Hospital, Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ming Kuang, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT03905967
Other Study ID Numbers:
  • 20190031
First Posted:
Apr 8, 2019
Last Update Posted:
Aug 20, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Ming Kuang, Clinical Professor, Sun Yat-sen University
Lenvatinib
Transarterial chemoembolisation
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Lenvatinib

Study Results

No Results Posted as of Aug 20, 2019