Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2019-12-17
• Target enrollment: 0
• Participant gender: All

Summary

Donafenib versus sorafenib for advanced hepatocellular cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Collaborator: Tigermed Consulting Co., Ltd
• Treatments: Niacinamide; Sorafenib

Criteria

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.