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

Primary Purpose

Advanced Hepatocellular Carcinoma

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

TACE

Lenvatinib

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma focused on measuring Lenvatinib, Transarterial chemoembolisation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-75 years old;
Patients with primary advanced HCC (in accordance with AASLD2018 guidelines for the diagnosis of HCC), without any previous treatment;
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;
ECOG score 0-1;
Child-Pugh class A;
Expected survival time ≥ 3 months;
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:

Preoperative imaging examination revealed diffuse intrahepatic lesions or invasion, inferior vena cava or primary branch bile duct;
Previous history of hepatic encephalopathy, refractory ascites or gastric esophageal varices;
There are contraindications to TACE treatment, such as portosystemic shunt, liver flow ablation, significant atherosclerosis;
Brain metastases;
Hypersensitivity to intravenous contrast agents;
Pregnant or lactating women or subjects with family planning within two years;
With HIV, syphilis infection;
Accompanied by other malignant tumors or suffering from other malignancies within 5 years before enrollment;
Allogeneic organ transplant recipients;
Severe dysfunction of heart and kidney or other organs;
Active severe infection > grade 2 (NCI-CTC version 4);
Suffering from mental and psychological diseases may affect informed consent;
Unable to take oral medication;
Participated in other drug clinical trials within 12 months before enrollment;

Sites / Locations

The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lenvatinib + TACE

Lenvatinib

Arm Description

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

Lenvatinib alone

Outcomes

Primary Outcome Measures

Overall survival

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

Secondary Outcome Measures

Time to progression

Defined as the time from randomization to disease progression.

Full Information

NCT ID

NCT03905967

First Posted

March 28, 2019

Last Updated

August 19, 2019

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03905967

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 16, 2019 (Actual)

Primary Completion Date

April 15, 2023 (Anticipated)

Study Completion Date

June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Hepatocellular Carcinoma

Keywords

Lenvatinib, Transarterial chemoembolisation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lenvatinib + TACE

Arm Type

Experimental

Arm Description

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

Arm Title

Lenvatinib

Arm Type

Active Comparator

Arm Description

Lenvatinib alone

Intervention Type

Procedure

Intervention Name(s)

TACE

Intervention Description

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

Drug

Intervention Name(s)

Lenvatinib

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall survival

Description

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

Time Frame

two years

Secondary Outcome Measure Information:

Title

Time to progression

Description

Defined as the time from randomization to disease progression.

Time Frame

two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-75 years old; Patients with primary advanced HCC (in accordance with AASLD2018 guidelines for the diagnosis of HCC), without any previous treatment; 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; ECOG score 0-1; Child-Pugh class A; Expected survival time ≥ 3 months; 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: Preoperative imaging examination revealed diffuse intrahepatic lesions or invasion, inferior vena cava or primary branch bile duct; Previous history of hepatic encephalopathy, refractory ascites or gastric esophageal varices; There are contraindications to TACE treatment, such as portosystemic shunt, liver flow ablation, significant atherosclerosis; Brain metastases; Hypersensitivity to intravenous contrast agents; Pregnant or lactating women or subjects with family planning within two years; With HIV, syphilis infection; Accompanied by other malignant tumors or suffering from other malignancies within 5 years before enrollment; Allogeneic organ transplant recipients; Severe dysfunction of heart and kidney or other organs; Active severe infection > grade 2 (NCI-CTC version 4); Suffering from mental and psychological diseases may affect informed consent; Unable to take oral medication; Participated in other drug clinical trials within 12 months before enrollment;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Kuang, PhD

Phone

008687755766

kuangm@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Kuang, PhD

Organizational Affiliation

First Affiliated Hospital, Sun Yat-Sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming Kuang, Ph.D.

Phone

008687755766

Ext

8576

kuangm@mail.sysu.edu.cn

12. IPD Sharing Statement

Citations:

PubMed Identifier

29433850

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.

Results Reference

background

PubMed Identifier

29307467

Citation

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.

Results Reference

background

PubMed Identifier

28648803

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.

Results Reference

background

PubMed Identifier

30529387

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.

Results Reference

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

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