Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma

NCT ID: NCT02645981

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 668 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-12-17

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.

Conditions

HCC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Donafenib

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

Group Type: EXPERIMENTAL

Donafenib

Intervention Type: DRUG

Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects

Sorafenib(Nexavar)

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

Group Type: ACTIVE_COMPARATOR

Sorafenib

Intervention Type: DRUG

Control

Interventions

Donafenib

Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects

Intervention Type: DRUG

Sorafenib

Control

Intervention Type: DRUG

Other Intervention Names

CM4307; Nexavar

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tigermed Consulting Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shukui Qin, MD

Role: STUDY_CHAIR

The PLA 81 Hospital

Feng Bi, MD

Role: STUDY_CHAIR

West China Hospital

Locations

The PLA 81 Hospital

Nanjing, Jiangsu, China

West China Hospital Sichuan University

Chengdu, Sichuan, China

Countries

China

References

Bi F, Qin S, Gu S, Bai Y, Chen Z, Wang Z, Ying J, Lu Y, Meng Z, Pan H, Yang P, Zhang H, Chen X, Xu A, Cui C, Zhu B, Wu J, Xin X, Wang J, Shan J, Chen J, Zheng Z, Xu L, Wen X, You Z, Ren Z, Xu J, Du C, Fan Q, Zhang L, Tao M, Jiang D, Wang S, Chen Y, Sheng J, Zhuang X, Wu J. Analysis of common treatment-related adverse events of donafenib and its correlation with efficacy: exploratory analysis of the ZGDH3 study. Eur J Med Res. 2025 Oct 29;30(1):1040. doi: 10.1186/s40001-025-03297-6.

Reference Type: DERIVED

PMID: 41163129 (View on PubMed)

Other Identifiers

ZGDH3

Identifier Type: -

Identifier Source: org_study_id