Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma

HCC Clinical Trial

Official title:

Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma: a Controlled,Multicentre,Randomised, Phase 3 Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645981
• Other study ID #: ZGDH3
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2016
• Est. completion date: December 17, 2019

Study information

• Verified date: October 2019
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Donafenib versus sorafenib for advanced hepatocellular cancer.

Description:

This phase 3 study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess efficacy and safety in patients wiht advanced hepatocellular carcinoma (HCC).The study is a randomised,controlled,multicentre study.The controlled drug is sorafenib(Nexavar).The primary endpoint is overall survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 668
• Est. completion date: December 17, 2019
• Est. primary completion date: November 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Above 18 years old;

• Patients with measurable, histologically or clinical proven, inoperable HCC;

• Patients wtih measurable lesion and proved by independent radiology committee(IRC);

• Child-Pugh (CP) score of 7 or less;

• Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less;

• Patients had not received prior systemic treatments for HCC;

• Life expectancy at least 3 months;

• Adequate hepatic and renal function;

• Adequate hematologic function (platelet count,=75×109per liter;hemoglobin =9.0g per deciliter;neutrophil=1.5×109per liter,);

• Prothrombin time international normal.

Exclusion Criteria:

• Patients received operate in 3 months;

• Patients received transcatheter arterial chemoembolization(TACE) in 4 weeks;

• Patients had received systemic therapy;

• Patients had prior treatment with sorafenib;

• Central nervous system(CNS) involvement;

• Severe or mild-degree ascitic fluid;

• Main portal vein tumor thrombus;

• Inferior venae cava tumor thrombus.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• HCC

Intervention

Drug:
• Donafenib
Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects
• Sorafenib
Control

Locations

Country	Name	City	State
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	The PLA 81 Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd	Tigermed Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Patient visits are scheduled every 8 weeks to monitor efficacy.	3 years
Secondary	Progress Free Survival	Patient visits are scheduled every 8 weeks to monitor efficacy.Progressive disease is measured from the date of randomization until dead or disease progression according to Response Evaluation Criteria in Solid Tumors(Version 1.1)	2 years
Secondary	Percentage of adverse events	Patient visits are scheduled every 4 weeks to monitor safety and drug accountability. Patients were monitored for adverse events by use of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) version 4.0	3 years