Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma
NCT ID: NCT06581315
Last Updated: 2024-09-03
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
204 participants
INTERVENTIONAL
2024-08-28
2032-08-30
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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Arm A (Donafenib)
Participants will receive Donafenib treatment until disease recurrence or unacceptable toxicity or up to 1 years.
Donafenib
Donafenib 100 mg twice daily (BID)
Arm B (active surveillance)
Active surveillance of participants.
No interventions assigned to this group
Interventions
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Donafenib
Donafenib 100 mg twice daily (BID)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* High Risk of recurrence as assessed by tumor characteristics
* Without any anti-tumor therapy before surgery, except preoperative TACE therapy, traditional Chinese medicine therapy and interferon therapy
* Child-Pugh Class A statu
* ECOG Performance Status of 0 or 1
* CT/MR confirmed no recurrence or metastasis at ≥4 weeks after surgery
* Expected survival time of no less than 3 months
Exclusion Criteria
* Evidence of residual or a history of spontaneous tumor rupture
* Recurrent HCC
* Prior received Liver transplantation
* Prior anti tumor therapy for treatment of HCC (including sorafenib or any other molecular therapy, anti-PD-1 antibody and other immunotherapies, FOLFOX systemic chemotherapy) is excluded
* AFP does not return to normal 4 weeks after operation
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Principal Investigators
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Changzhen Shang, MD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
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Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SYXKY-2024-666-02
Identifier Type: -
Identifier Source: org_study_id
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