Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma

Zelgen Biopharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: HCC

Treatments: Drug: Donafenib; Drug: Sorafenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02645981

ZGDH3

Details and patient eligibility

About

Donafenib versus sorafenib for advanced hepatocellular cancer.

Full 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.

Enrollment: 668 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

668 participants in 2 patient groups

Donafenib

Experimental group

Description:

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

Treatment:

Drug: Donafenib

Sorafenib(Nexavar)

Active Comparator group

Description:

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

Treatment:

Drug: Sorafenib