Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

August 30, 2024 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Efficacy and Safety of Donafenib as Adjuvant Therapy for Postoperative Patients With High-Risk Recurrent Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Arm B (active surveillance)
Active surveillance of participants.
Experimental: Arm A (Donafenib)
Participants will receive Donafenib treatment until disease recurrence or unacceptable toxicity or up to 1 years.
Drug: Donafenib
Donafenib 100 mg twice daily (BID)
Other Names:
  • Zepsun

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One year recurrence-free survival (RFS) rate
Time Frame: 1 year
The proportion from randomization to 1 year without recurrence.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Principal Investigator: Changzhen Shang, MD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 28, 2024

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2032

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 3, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYXKY-2024-666-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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