Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma; Adjuvant Therapy
• Interventions: Drug: Donafenib

• Registration Number: NCT06581315
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 controlled study.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-28
• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Last Update Submitted: 2024-08-30
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Primary Completion: 2027-08-30
• Study Completion: 2032-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (Donafenib)	Donafenib	Participants will receive Donafenib treatment until disease recurrence or unacceptable toxicity or up to 1 years.

Primary Outcome Measures

Name	Time	Method
One year recurrence-free survival (RFS) rate	1 year	The proportion from randomization to 1 year without recurrence.

Secondary Outcome Measures

Name	Time	Method
Recurrence-Free Survival (RFS )	6 years	The time from randomization to disease recurrence, or death from any cause (whichever occurs first).
Recurrence-Free Survival rate (RFS rate)	5 years	The proportion from randomization to 2 years, 3 years or 5 years without recurrence.
Overall Survival (OS)	6 years	The time from randomization to death from any cause.

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China