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Trial Title:
Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC
NCT ID:
NCT06609876
Condition:
Hepatocellular Carcinoma
Microwave Ablation
Donafenib
Recurrent Tumor
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Thermal ablation
Description:
Thermal ablation of tumors
Arm group label:
Microwave ablation plus Donafenib
Arm group label:
Thermal ablation
Intervention type:
Drug
Intervention name:
Donafenib
Description:
Donafenib ( 100 mg，bid)
Arm group label:
Microwave ablation plus Donafenib
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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 or
no 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 prolonged
prothrombin 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 informed
consent document.
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese PLA General hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Qunfang Zhou
Email:
zhouqun988509@163.com
Contact backup:
Last name:
Feng Duan
Phone:
8613910984586
Email:
duanfeng@vip.sina.com
Start date:
October 1, 2024
Completion date:
October 1, 2028
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06609876
