Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma

Conditions

HCC

Keywords

Donafeinb, Sorafenib, Phase 3, Overall Survival

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.

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.

2025-10-29

10.1186/s40001-025-03297-6

OS analysis of patients with different short-term response and progression patterns of donafenib versus sorafenib as first-line therapy for advanced hepatocellular carcinoma: An exploratory subgroup analysis of ZGDH3.

Shukui Qin, Feng Bi, Jianming Xu, Chengyou Du, Qingxia Fan et al. (13 authors)

Journal of Clinical Oncology2023-06-01

10.1200/jco.2023.41.16_suppl.e16143

Donafenib versus sorafenib as first-line therapy in advanced hepatocellular carcinoma: An open-label, randomized, multicenter phase II/III trial.

Feng Bi, Shukui Qin, Shanzhi Gu, Yuxian Bai, Zhendong Chen et al. (18 authors)

Journal of Clinical Oncology2020-05-2039 citations

10.1200/jco.2020.38.15_suppl.4506

Interventions

DRUGDonafenib

Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects

DRUGSorafenib

Control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

open-label

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Overall Survival	3 years	Patient visits are scheduled every 8 weeks to monitor efficacy.

Secondary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed