Efficacy and Safety of Donafenib as Adjuvant Therapy for Postoperative Patients With High-Risk Recurrent Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Changzhen Shang, MD
shchzh2@mail.sysu.edu.cn
+86-20-3407 0701
Time Frame
Start Date: 2024-08-28
Estimated Completion Date: 2032-08-30
Participants
Target number of participants: 204
Treatments
Experimental: Arm A (Donafenib)
Participants will receive Donafenib treatment until disease recurrence or unacceptable toxicity or up to 1 years.
No_intervention: Arm B (active surveillance)
Active surveillance of participants.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University