Status:
RECRUITING
Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Hepatocellular Carcinoma
Adjuvant Therapy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2032
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT06581315
Start Date
August 28 2024
End Date
August 30 2032
Last Update
September 3 2024
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510120