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Trial Title:
Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma
NCT ID:
NCT06581315
Condition:
Hepatocellular Carcinoma
Adjuvant Therapy
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular Carcinoma
Adjuvant Therapy
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:
Drug
Intervention name:
Donafenib
Description:
Donafenib 100 mg twice daily (BID)
Arm group label:
Arm A (Donafenib)
Other name:
Zepsun
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Changzhen Shang, MD
Phone:
+86-20-3407 0701
Email:
shchzh2@mail.sysu.edu.cn
Start date:
August 28, 2024
Completion date:
August 30, 2032
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of 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/NCT06581315
