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Advanced Hepatocellular CarcinomaPhase 3TACENCT03905967

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

A Phase 3 study testing TACE and Lenvatinib in people with Advanced Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Hepatocellular Carcinoma
What is being tested?
TACE and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
336 participants
Where
1 siteChina
Study dates
16 Jun 2019to 15 Jun 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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;

Trial locations and contacts

1 site in 1 country.

Ming Kuang, PhD contact

008687755766

kuangm@mail.sysu.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    Ming Kuang, Ph.D., 008687755766 ext. 8576, kuangm@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Being tested
TACE, Lenvatinib
Keywords
Lenvatinib, Transarterial chemoembolisation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TACEProcedure or surgery

    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.

  • LenvatinibDrug

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

Study groups in NCT03905967
Study groupRoleWhat they receive
Lenvatinib + TACEExperimentalPatients in Lenvatinib + TACE group will take oral lenvatinib within 3 days of randomization and receive TACE 1 day after oral administration of lenvatinib.
Receives: Procedure: TACE; Drug: Lenvatinib
LenvatinibActive comparatorLenvatinib alone
Receives: Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

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

    Measured: two years

Secondary outcomes (1)

  1. Time to progression

    Defined as the time from randomization to disease progression.

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2019
  2. Study start16 Jun 2019
  3. Primary completion15 Apr 2023 (estimated)
  4. Study completion15 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
336 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03905967
Sponsor's protocol ID
20190031
Acronym
TACE
Status last verified
Aug 2019
First submitted
28 Mar 2019
Last updated
20 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29433850

  • 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.

    PubMed 29307467

  • 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.

    PubMed 28648803

  • 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.

    PubMed 30529387

  • 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.

    PubMed 35921605

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TACE and Lenvatinib in people with Advanced Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ming Kuang, PhD (008687755766, kuangm@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03905967, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.

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