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

NCT ID: NCT03905967

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-16
• Study Completion Date: 2023-06-15

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.

Conditions

Advanced Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TACE

Intervention Type: PROCEDURE

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.

Lenvatinib

Intervention Type: DRUG

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

Lenvatinib

Lenvatinib alone

Group Type: ACTIVE_COMPARATOR

Lenvatinib

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: PROCEDURE

Lenvatinib

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

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming Kuang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Kuang, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Kuang, PhD

Role: CONTACT

kuangm@mail.sysu.edu.cn

008687755766

Facility Contacts

Ming Kuang, Ph.D.

Role: primary

kuangm@mail.sysu.edu.cn

008687755766 ext. 8576

References

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Reference Type: BACKGROUND

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Forner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018 Mar 31;391(10127):1301-1314. doi: 10.1016/S0140-6736(18)30010-2. Epub 2018 Jan 5.

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Reference Type: BACKGROUND

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Peng Z, Fan W, Zhu B, Wang G, Sun J, Xiao C, Huang F, Tang R, Cheng Y, Huang Z, Liang Y, Fan H, Qiao L, Li F, Zhuang W, Peng B, Wang J, Li J, Kuang M. Lenvatinib Combined With Transarterial Chemoembolization as First-Line Treatment for Advanced Hepatocellular Carcinoma: A Phase III, Randomized Clinical Trial (LAUNCH). J Clin Oncol. 2023 Jan 1;41(1):117-127. doi: 10.1200/JCO.22.00392. Epub 2022 Aug 3.

Reference Type: DERIVED

PMID: 35921605 (View on PubMed)

Other Identifiers

20190031

Identifier Type: -

Identifier Source: org_study_id