Actively Recruiting
Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-09-03
204
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization
- High risk of recurrence based on tumor characteristics
- No prior anti-tumor therapy before surgery except preoperative TACE, traditional Chinese medicine, or interferon therapy
- Child-Pugh Class A liver function status
- ECOG Performance Status of 0 or 1
- CT or MRI confirms no recurrence or metastasis at least 4 weeks after surgery
- Expected survival time of at least 3 months
You will not qualify if you...
- Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma and hepatocellular carcinoma
- Evidence of residual tumor or history of spontaneous tumor rupture
- Recurrent hepatocellular carcinoma
- Prior liver transplantation
- Prior anti-tumor therapy for hepatocellular carcinoma, including sorafenib, other molecular therapies, anti-PD-1 antibody, immunotherapies, or FOLFOX chemotherapy
- Alpha-fetoprotein (AFP) levels not returning to normal 4 weeks after surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
C
Changzhen Shang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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