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The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma

ConditionsRecurrent Hepatocellular CarcinomaLenvatinibLocal TherapyAblationSystemic Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

Studies have shown that combination therapy of TACE with Lenvatinib could achieve better survival outcomes than TACE alone for hepatocellular carcinoma (HCC) at BCLC B stage. However, whether patients could benefit from the ablation for intermediate recurrent HCC (RHCC) is still need high quality clinical evidence. This study is to evaluate the efficacy of ablation combined with TACE and Lenvatinib for the intermediate-stage RHCC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-75 years;

RHCC diagnosed by imaging;

intermediate-stage RHCC (two to three lesions which at least one was >3 cm in size or more than three tumors);

the tumor number was no more than six, and the maximum tumor diameter was ≤5 cm;

Disqualifiers

under 18 years or over 75 years of age;

primary intermediate-stage HCC;

RHCC with more than six tumors, or single RHCC

Trial design

Design model

Parallel

Treatments tested in this trial

  • TACE

    Procedure/Surgery

    TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.

  • Ablation

    Procedure/Surgery

    Ablation (radiofrequency ablation, microwave ablation, cryoablation), ablation followed TACE within 6-8 weeks and Lenvatinib continued. Percutaneous ablation was performed by ultrasound or CT. The ablation success is evaluated by achieving an ablative margin of 0.5 cm or more than the tumor size.

  • Lenvatinb

    Drug

    Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day )

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: TACE plus LenvatinibActive comparator 2 interventions
Group B: TACE plus Lenvatinib and ablationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

PFS is defined as the time from the date of inclusion to the date of the first objectively documented tumor progression or death due to any cause.

Time frame
24 months

Secondary outcomes

1

Overall survival (OS)

OS is the length of time from the date of inclusion until death from any cause.

Time frame
36 month
2

Objective response rate (ORR)

ORR, as determined based on tumor response according to mRECIST, is defined as partial response and complete response.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Chinese PLA General Hospital

Collaborator

Source ClinicalTrials.gov
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