Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC

Last updated: December 1, 2024
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Liver Cancer

Liver Disease

Treatment

Thermal ablation

Donafenib

Clinical Study ID

NCT06609876
Liver Projiect1
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. were aged 18-75 years;

  2. had recurrent HCC (RHCC) diagnosed by imaging studies, the first or the second RHCC;

  3. RHCC met the Milan criteria, namely single RHCC lesion less than 5 cm in diameter orno more than 3 tumors (each ≤3 cm in diameter);

  4. the early RHCC (recurrent time <1 year)

  5. patients were unwilling to undergo repeat hepatectomy or liver transplantation;

  6. had well-preserved liver function, i.e., Child-Pugh class A or B, and prolongedprothrombin time≤5 s;

  7. patients had an Eastern Cooperative Oncology Group performance status score ≤1.

  8. Ability to understand the protocol and to agree to and sign a written informedconsent document.

Exclusion

Exclusion Criteria:

  1. were under 18 years or over 75 years of age;

  2. primary HCC;

  3. recurrent HCC beyond Milan criteria;

  4. RHCC with metastasis or macrovascular tumor thrombus

Study Design

Total Participants: 108
Treatment Group(s): 2
Primary Treatment: Thermal ablation
Phase:
Study Start date:
October 01, 2024
Estimated Completion Date:
October 01, 2028

Study Description

Thermal ablation is available as the major curative treatments for early-stage recurrent HCC. Donafenib was inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated low-dose donafenib as adjuvant therapy after thermal ablation. There needs further investigation to explore the efficacy and safety of the combination treatment. Thus, the investigators carried out this prospective, randomized, open-label, phase II trial study to find out it.

Connect with a study center

  • Chinese PLA General hospital

    Beijing, None Selected 100853
    China

    Active - Recruiting

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