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Hepatocellular CarcinomaPhase 3NCT03791918

Lenvatinib Plus PD-1 Antibody vs TACE for Intermediate-stage HCC Beyond Up-to-seven Criteria

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

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody compared with transarterial chemoembolization (TACE) for patients with intermediate-stage hepatocellular carcinoma (HCC) beyond up-to-seven criteria Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Lenvatinib, PD-1 antibody and TACE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesChina
Study dates
1 Jan 2019to 1 Jan 2022
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

  • The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
  • Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
  • Barcelona clinic liver cancer-stage B
  • Beyond up-to-seven criteria (hepatocellular carcinomas with seven as the sum of the size of the largest tumor [in cm] and the number of tumors)
  • Eastern Cooperative Oncology Group performance status of 0 to 1
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only
Show all 10Show fewer
  • Not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy.
  • The following laboratory parameters:
  • Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
  • Ability to understand the protocol and to agree to and sign a written informed consent document

Who cannot join

  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
  • Known history of HIV
  • History of organ allograft
  • Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Evidence of bleeding diathesis.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • Known central nervous system tumors including metastatic brain disease

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Cancer Center Sun Yat-sen University

    Guangzhou, Guangdong, 510060

  • Guangzhou Twelfth People 's Hospita

    Guangzhou, Guangdong, 510620

  • Kaiping Central Hospital

    Kaiping, Guangdong, 529300

Other trials in China

About this study

Official title: Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Antibody Versus Transarterial Chemoembolization for Intermediate-stage Hepatocellular Carcinoma Beyond Up-to-seven Criteria

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody compared with transarterial chemoembolization (TACE) for patients with intermediate-stage hepatocellular carcinoma (HCC) beyond up-to-seven criteria

Read the detailed description

Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of TACE for patients with hepatocellular carcinoma staged BCLC A/B especially for those with tumor beyond up-to-seven criteria. Recently, Lenvatinib was proved non-inferior to sorafenib in overall survival in advanced hepatocellular carcinoma, and Programmed Cell Death Protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated the efficacy and safety of lenvatinib plus PD-1 antibody in intermediate-stage HCC. Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of lenvatinib combined with PD-1 antibody over TACE.

Being tested
Lenvatinib, PD-1 antibody, TACE, TACE Drug Protocol
Keywords
Hepatocellular Carcinoma, Lenvatinib, PD-1 Antibody, TACE
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • LenvatinibDrug

    Also called E7080, Lenvima

    12 mg (or 8 mg) once daily (QD) oral dosing.

  • PD-1 antibodyDrug

    Also called Programmed cell death 1 antibody

    3mg/kg intravenously every 2 weeks

  • TACEProcedure or surgery

    Also called Transarterial chemoembolization

    A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. TACE Drug Protocol were injected.

  • TACE Drug ProtocolDrug

    Also called Drugs for transarterial chemotherapy and embolization

    lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, and MMC) followed by polyvinyl alcohol particles (PVA)

Study groups in NCT03791918
Study groupRoleWhat they receive
Lenvatinib Plus PD-1ExperimentalParticipants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 14-day treatment cycles, and received 3mg/kg PD-1 antibody intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Receives: Drug: Lenvatinib; Drug: PD-1 antibody
TACEActive comparatorHepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA).
Receives: Procedure: TACE; Drug: TACE Drug Protocol

What is being measured

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

  1. Overall survival

    Measured: 24 months

Secondary outcomes (3)

  1. Time to progression

    Measured: 24 months

  2. Adverse Events

    Measured: 24 months

  3. Progression free survival

    Measured: 24 months

Timeline

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

  1. First posted3 Jan 2019
  2. Study start1 Jan 2019
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Jan 2022 (estimated)

Why it stopped: No participants enrolled

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03791918
Sponsor's protocol ID
HCC-S065
Status last verified
Jan 2019
First submitted
1 Jan 2019
Last updated
2 May 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenvatinib, PD-1 antibody and TACE in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 3 sites 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 10 inclusion and 8 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: withdrawn, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 24 months). 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 NCT03791918.

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 2 May 2019.

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