NCT03905967

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
336

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2019

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 16, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

3.8 years

First QC Date

March 28, 2019

Last Update Submit

August 19, 2019

Conditions

Advanced Hepatocellular Carcinoma

Keywords

LenvatinibTransarterial chemoembolisation

Outcome Measures

Primary Outcomes (1)

  • Overall survival

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

    two years

Secondary Outcomes (1)

  • Time to progression

    two years

Study Arms (2)

Lenvatinib + TACE

EXPERIMENTAL

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: TACEDrug: Lenvatinib

Lenvatinib

ACTIVE COMPARATOR

Lenvatinib alone

Drug: Lenvatinib

Interventions

TACEPROCEDURE

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 + TACE
LenvatinibDRUG

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

LenvatinibLenvatinib + TACE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 29433850BACKGROUND

  • 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.

    PMID: 29307467BACKGROUND

  • 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.

    PMID: 28648803BACKGROUND

  • 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.

    PMID: 30529387BACKGROUND

  • 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.

    PMID: 35921605DERIVED

MeSH Terms

Interventions

lenvatinib

Study Officials

  • Ming Kuang, PhD

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Kuang, PhD

CONTACT

008687755766kuangm@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 28, 2019

First Posted

April 8, 2019

Study Start

June 16, 2019

Primary Completion

April 15, 2023

Study Completion

June 15, 2023

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

CN(1)