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Recruiting NCT06609850

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

No phase Interventional Recurrent Hepatocellular Carcinoma Lenvatinib Local Therapy Ablation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TACE, Ablation, Lenvatinb.
Who it may be relevant to
Registry conditions: Recurrent Hepatocellular Carcinoma, Lenvatinib, Local Therapy, Ablation. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure TACE
    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.
  • Procedure Ablation
    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.
  • Drug Lenvatinb
    Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day )

Primary outcome measures

  • Progression free survival (PFS) [Time frame: 24 months]
Secondary outcome measures (2)
  • Overall survival (OS) [Time frame: 36 month]
  • Objective response rate (ORR) [Time frame: 12 months]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Chinese PLA General hospital — Beijing

Identifiers

NCT: NCT06609850 · Liver Projiect 10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗