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NCT Number: NCT06609850

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The evidence of ablation combined transarterial chemoembolisation (TACE) and Lenvatinib for intermediate-stage recurrent hepatocellular carcinoma (RHCC) is limited. Patient responses to this treatment vary because of the heterogeneous nature of RHCC. Thus, it is important to identify patients who are most likely to benefit from this three regimes therapy. The aim of this study is to comparison of TACE-Lenvatinib with TACE-Lenvatinib-ablation for intermediate RHCC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • absence of extrahepatic metastasis or macrovascular invasion;
  • Child-Pugh class A or B;
  • TACE as initial treatment after tumor recurrence and showed no tumor progression after TACE.
  • life expectance >3 months;

Exclusion criteria

  • under 18 years or over 75 years of age;
  • primary intermediate-stage HCC;
  • RHCC with more than six tumors, or single RHCC

(5) RHCC >5cm; (6) extrahepatic metastasis; (7) macrovascular tumor thrombus;

Treatment and study plan

TACE

Procedure

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

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 )

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: 24 months

    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.

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 36 month

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

  2. Objective response rate (ORR)

    Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Duan

CONTACT

[email protected]

86 13910984586

Qunfang Zhou

CONTACT

[email protected]

86 19868000115

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Chinese PLA General Hospital

Registry information

Official study title

The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma: a Multicenter Randomized Control Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Sep 24, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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