Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC
NCT ID: NCT06609876
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
108 participants
INTERVENTIONAL
2024-10-01
2028-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Thermal ablation
Patients only accepted thermal ablation (microwave ablation,radiofrequency ablation)
Thermal ablation
Thermal ablation of tumors
Microwave ablation plus Donafenib
Patients accepted thermal ablation (microwave ablation,radiofrequency ablation) plus Donafenib (100mg, bid)
Thermal ablation
Thermal ablation of tumors
Donafenib
Donafenib ( 100 mg，bid)
Interventions
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Thermal ablation
Thermal ablation of tumors
Donafenib
Donafenib ( 100 mg，bid)
Eligibility Criteria
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Inclusion Criteria
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
2. primary HCC;
3. recurrent HCC beyond Milan criteria;
4. RHCC with metastasis or macrovascular tumor thrombus
18 Years
75 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Zhou Qunfang
Clinical Professor
Principal Investigators
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Feng Duan, Professor
Role: STUDY_DIRECTOR
Chinese PLA General Hospital
Locations
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Chinese PLA General hospital
Beijing, None Selected, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Liver Projiect1
Identifier Type: -
Identifier Source: org_study_id