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Advanced Hepatocellular CarcinomaPhase 3NCT05738616

Lenvatinib Combined With TACE and Camrelizumab in Conversion Resection for Advanced Hepatocellular Carcinoma (LEN-TAC Study)

A Phase 3 study testing Lenvatinib combined with TACE and Camrelizumab in people with Advanced Hepatocellular Carcinoma, run by Wen Tianfu at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Compared to systemic therapy alone, conversion therapy is promising to improve the prognosis of patients with advanced hepatocellular carcinoma (HCC). Triple therapy (lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab) may have significant efficacy in conversion therapy for 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?
Lenvatinib combined with TACE and Camrelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteChina
Study dates
10 May 2024to 1 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Aged between 18 and 75 years.
  • Patients with HCC who strictly meet the criteria outlined in the Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2022Edition), or those diagnosed by histopathology or cytology.
  • No prior anticancer therapy for HCC(Excluding patients who have received two or fewer TACE treatments).
  • ECOG PS score of 0-1.
  • Child-Pugh class A to B.
  • BCLC stage C Patients: tumor localized in one half of the liver with portal vein tumor thrombus (Vp1-Vp4 patients without contralateral portal vein tumor thrombus).
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  • At least one radiographically measurable lesion according to mRECIST.
  • For HBsAg-positive patients, HBV-DNA < 2000 IU/ml (10^4 copies/ml) when undergoing PD-1 monoclonal antibody treatment; HCV RNA negative when HCV antibody is positive.
  • Adequate organ function based on laboratory test results.
  • Adequate blood pressure control with up to 3 antihypertensive agents, defined as BP ≤ 150/90 mmHg at screening with no changes in antihypertensive therapy within 1 week prior to Cycle 1/Day 1.
  • Patients expected to survive more than 3 months.
  • Not planning to become pregnant.

Who cannot join

  • Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular carcinoma, and fibrolamellar cell carcinoma.
  • Extrahepatic metastasis of HCC.
  • Diffuse HCC or intrahepatic tumor burden ≥ 50% (including contralateral portal vein tumor thrombus, superior mesenteric vein tumor thrombus, and inferior vena cava tumor thrombus).
  • Contraindications to TACE or epirubicin.
  • Known hypersensitivity to lenvatinib ingredients.
  • Known hypersensitivity to the active ingredient or excipients of Camrelizumab.
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  • Presence of other malignancies.
  • Pregnancy, lactation, or unwillingness to use effective contraceptive measures.
  • Class II or higher myocardial ischemia or infarction, poorly controlled arrhythmia, cardiac insufficiency class III-IV, or LVEF < 50%.
  • Abnormal coagulation function or bleeding tendency.
  • History of psychiatric disorders or substance abuse.
  • HIV infection.
  • Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Active infection.
  • Poor compliance such as floating population.
  • Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
  • Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.
  • Systemic glucocorticoid or immunosuppressive therapy within 7 days prior to the first dose.
  • Clinically uncontrolled pleural/peritoneal effusion.
  • Active chronic hepatitis B or C.
  • Vaccination with live vaccines within 30 days prior to the first dose.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tianfu Wen, Professor contact

86-18980601471

wentianfu@scu.edu.cn

China1 site, 1 recruiting

  • HuaXi hospital

    Chengdu, Sichuan, 610000

    Tianfu Wen, Professor, 86-18980601471, wentianfu@scu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Lenvatinib Combined With Transcatheter Arterial Chemoembolization and Camrelizumab Versus Lenvatinib Combined With Transcatheter Arterial Chemoembolization in Conversion Resection for Advanced Hepatocellular Carcinoma:A Randomized, Open-label, Parallel-controlled, Phase III Study(LEN-TAC Study)

Compared to systemic therapy alone, conversion therapy is promising to improve the prognosis of patients with advanced hepatocellular carcinoma (HCC). Triple therapy (lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab) may have significant efficacy in conversion therapy for patients with advanced HCC, but its safety and efficacy remain unknown. To address this, we have designed a randomized, open-label, parallel-controlled trial to evaluate the safety and efficacy of lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab versus lenvatinib combined with transcatheter arterial chemoembolization in conversion resection for advanced HCC. Totally 196 patients with BCLC C stage HCC will be rigorously screened and included, and the primary endpoints of the study are overall survival. This study aims to provide valuable insights into new treatment strategies for advanced HCC.

Being tested
Lenvatinib combined with TACE and Camrelizumab
Keywords
Conversion resection, Lenvatinib, Transcatheter arterial chemoembolization, Camrelizumab, Advanced hepatocellular carcinoma

What participants receive

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

  • Lenvatinib combined with TACE and CamrelizumabCombination product

    Once subjects have signed the informed consent and passed screening, they will be randomized in a 1:1 ratio to either the experimental arm (lenvatinib combined with TACE and camrelizumab) or the control arm (lenvatinib combined with TACE).

Study groups in NCT05738616
Study groupRoleWhat they receive
lenvatinib combined with TACE and camrelizumabExperimentalNot described
Receives: Combination Product: Lenvatinib combined with TACE and Camrelizumab
lenvatinib combined with TACEActive comparatorNot described
Receives: Combination Product: Lenvatinib combined with TACE and Camrelizumab

What is being measured

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

  1. Overall survival

    Time from randomization to death (any cause).

    Measured: 3-year

Secondary outcomes (6)

  1. Adverse events

    The occurrence of any hematological or non-hematological toxicity event (≥ class Ⅲ), including but not limited to impaired liver function, impaired hematological system, hypertension, diarrhea, proteinuria, hand-foot syndrome, etc. Severity of adverse events will be graded according to CTCAE v5.0.

    Measured: 2 years

  2. Objective response rate

    The percentage of patients achieving complete response and partial response among all patients. Response to treatment will be evaluated according to mRECIST.

    Measured: 2 years

  3. Disease control rate

    The percentage of patients with complete response, partial response and stable disease among all patients.

    Measured: 2 years

  4. Event-free survival

    Time from randomization to disease progression, local recurrence, distant metastasis, or death, whichever occurs first, assessed by mRECIST

    Measured: 2 years

  5. Overall survival at 2 years

    The time from start of treatment until death from any cause or the end of the study (the last enrolled patient should be followed for at least 2 years

    Measured: 2 years

  6. Conversional resection rate

    conversional resection patients/enrolled patients

    Measured: 2 years

Timeline

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

  1. First posted22 Feb 2023
  2. Study start10 May 2024 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 Dec 2027 (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
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05738616
Sponsor's protocol ID
HX-IRB-AF-03-V1.0
Status last verified
Apr 2024
First submitted
12 Feb 2023
Last updated
24 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenvatinib combined with TACE and Camrelizumab in people with Advanced Hepatocellular Carcinoma, run by Wen Tianfu 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 12 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 24 Apr 2024. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Tianfu Wen, Professor (86-18980601471, wentianfu@scu.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: 3-year). 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 NCT05738616.

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 24 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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