Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma

Phase 2

Completed

• Conditions: HCC
• Interventions: Drug: Sorafenib; Drug: Donafenib

• Registration Number: NCT02645981
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

Donafenib versus sorafenib for advanced hepatocellular cancer.

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 Timeline

• Study First Submitted: 2015-12-31
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-05
• Study Start: 2016-03
• Status Verified: 2019-10
• Primary Completion: 2019-11-27
• Study Completion: 2019-12-17
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 668

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sorafenib(Nexavar)	Sorafenib	Drug:Sorafenib; Dose:400mg,bid,po.
Donafenib	Donafenib	Drug:Donafenib; Dose:200mg,bid,po.

Primary Outcome Measures

Name	Time	Method
Overall Survival	3 years	Patient visits are scheduled every 8 weeks to monitor efficacy.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

West China Hospital Sichuan University; 🇨🇳 Chengdu, Sichuan, China

The PLA 81 Hospital; 🇨🇳 Nanjing, Jiangsu, China