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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Chinese PLA General hospital
RECRUITING
Beijing
Contact Information
Primary
Qunfang Zhou, MD
zhouqun988509@163.com
86 19868000115
Backup
Feng Duan, Professor
duanfeng@vip.sina.com
86 13910984586
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 108
Treatments
Experimental: Thermal ablation
Patients only accepted thermal ablation (microwave ablation,radiofrequency ablation)
Experimental: Microwave ablation plus Donafenib
Patients accepted thermal ablation (microwave ablation,radiofrequency ablation) plus Donafenib (100mg, bid)
Related Therapeutic Areas
Sponsors
Collaborators: Chinese PLA General Hospital
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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