Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma

Study Overview
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Brief Summary
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Donafenib versus sorafenib for advanced hepatocellular cancer.

Detailed Description
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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.

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

Conditions
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HCC

Intervention / Treatment
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* Drug: Donafenib
* Drug: Sorafenib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Donafenib<br>Drug:Donafenib; Dose:200mg,bid,po. | Drug: Donafenib<br>* Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects<br>* Other names: CM4307;|
| Active Comparator: Sorafenib(Nexavar)<br>Drug:Sorafenib; Dose:400mg,bid,po. | Drug: Sorafenib<br>* Control<br>* Other names: Nexavar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Patient visits are scheduled every 8 weeks to monitor efficacy. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Donafeinb, Sorafenib, Phase 3, Overall Survival