RecruitingNot ApplicableNCT06609876

Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC

Thermal Ablation Combined With Low-dose Donafinib for Early Recurrent Hepatocellular Carcinoma: a Multicenter Prospective Study


Sponsor

Sun Yat-sen University

Enrollment

108 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study intends to evaluate the efficacy and safety of low-dose adjuvant donafenib after thermal ablation for early recurrent HCC within Milan criteria.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

  • were aged 18-75 years;
  • had recurrent HCC (RHCC) diagnosed by imaging studies, the first or the second RHCC;
  • RHCC met the Milan criteria, namely single RHCC lesion less than 5 cm in diameter or no more than 3 tumors (each ≤3 cm in diameter);
  • the early RHCC (recurrent time \<1 year)
  • patients were unwilling to undergo repeat hepatectomy or liver transplantation;
  • had well-preserved liver function, i.e., Child-Pugh class A or B, and prolonged prothrombin time≤5 s;
  • patients had an Eastern Cooperative Oncology Group performance status score ≤1.
  • Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria4

  • were under 18 years or over 75 years of age;
  • primary HCC;
  • recurrent HCC beyond Milan criteria;
  • RHCC with metastasis or macrovascular tumor thrombus

Interventions

PROCEDUREThermal ablation

Thermal ablation of tumors

DRUGDonafenib

Donafenib ( 100 mg,bid)


Locations(1)

Chinese PLA General hospital

Beijing, None Selected, China

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NCT06609876


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