Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT02645981

Collaborator

Tigermed Consulting Co., Ltd (Industry)

668

Enrollment

Locations

Arms

45.5

Duration (Months)

334

Patients Per Site

7.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Donafenib versus sorafenib for advanced hepatocellular cancer.

Condition or Disease	Intervention/Treatment	Phase
HCC	Drug: Donafenib Drug: Sorafenib	Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

668 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

open-label

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Nov 27, 2019

Actual Study Completion Date :

Dec 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Donafenib Drug:Donafenib; Dose:200mg,bid,po.	Drug: Donafenib Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects Other Names: CM4307
Active Comparator: Sorafenib(Nexavar) Drug:Sorafenib; Dose:400mg,bid,po.	Drug: Sorafenib Control Other Names: Nexavar

Arm

Intervention/Treatment

Experimental: Donafenib

Drug:Donafenib; Dose:200mg,bid,po.

Drug: Donafenib

Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects

Other Names:

CM4307

Active Comparator: Sorafenib(Nexavar)

Drug:Sorafenib; Dose:400mg,bid,po.

Drug: Sorafenib

Control

Other Names:

Nexavar

Outcome Measures

Primary Outcome Measures

Overall Survival [3 years]
Patient visits are scheduled every 8 weeks to monitor efficacy.

Secondary Outcome Measures

Progress Free Survival [2 years]
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)
Percentage of adverse events [3 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.