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

Advanced Hepatocellular Carcinoma Clinical Trial

— TACE  

Official title:

Transarterial Chemoembolization With Lenvatinib Versus Lenvatinib Alone in First-line Treatment of Advanced Hepatocellular Carcinoma: a Phase III, Multicenter, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03905967
• Other study ID #: 20190031
• Status: Recruiting
• Phase: Phase 3
• Start date: June 16, 2019
• Est. completion date: June 15, 2023

Study information

• Verified date: August 2019
• Source: Sun Yat-sen University
• Contact: Ming Kuang, PhD
• Phone: 008687755766
• Email: kuangm[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: June 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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)

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. Review. — View Citation

Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1. — View Citation

Meyer T, Fox R, Ma YT, Ross PJ, James MW, Sturgess R, Stubbs C, Stocken DD, Wall L, Watkinson A, Hacking N, Evans TRJ, Collins P, Hubner RA, Cunningham D, Primrose JN, Johnson PJ, Palmer DH. Sorafenib in combination with transarterial chemoembolisation in patients with unresectable hepatocellular carcinoma (TACE 2): a randomised placebo-controlled, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2017 Aug;2(8):565-575. doi: 10.1016/S2468-1253(17)30156-5. Epub 2017 Jun 23. Erratum in: Lancet Gastroenterol Hepatol. 2017 Sep;2(9):e6. — View Citation

Park JW, Kim YJ, Kim DY, Bae SH, Paik SW, Lee YJ, Kim HY, Lee HC, Han SY, Cheong JY, Kwon OS, Yeon JE, Kim BH, Hwang J. Sorafenib with or without concurrent transarterial chemoembolization in patients with advanced hepatocellular carcinoma: The phase III STAH trial. J Hepatol. 2019 Apr;70(4):684-691. doi: 10.1016/j.jhep.2018.11.029. Epub 2018 Dec 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Defined as the time from randomization to death for any cause.	two years
Secondary	Time to progression	Defined as the time from randomization to disease progression.	two years