RecruitingNot ApplicableNCT06581315
Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma
Efficacy and Safety of Donafenib as Adjuvant Therapy for Postoperative Patients With High-Risk Recurrent Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Study
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Enrollment
204 participants
Start Date
Aug 28, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria7
- Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization
- 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 Criteria6
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- 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
Interventions
DRUGDonafenib
Donafenib 100 mg twice daily (BID)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06581315
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