NCT02645981

Brief Summary

Donafenib versus sorafenib for advanced hepatocellular cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
668

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2016

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2019

Completed
Last Updated

January 9, 2020

Status Verified

October 1, 2019

Enrollment Period

3.7 years

First QC Date

December 31, 2015

Last Update Submit

January 7, 2020

Conditions

HCC

Keywords

DonafeinbSorafenibPhase 3Overall Survival

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Patient visits are scheduled every 8 weeks to monitor efficacy.

    3 years

Secondary Outcomes (2)

  • Progress Free Survival

    2 years

  • Percentage of adverse events

    3 years

Study Arms (2)

Donafenib

EXPERIMENTAL

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

Drug: Donafenib

Sorafenib(Nexavar)

ACTIVE COMPARATOR

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

Drug: Sorafenib

Interventions

DonafenibDRUG

Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects

Also known as: CM4307
Donafenib
SorafenibDRUG

Control

Also known as: Nexavar
Sorafenib(Nexavar)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The PLA 81 Hospital

Nanjing, Jiangsu, 025, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, 610042, China

Location

Related Publications (1)

  • 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.

    PMID: 41163129DERIVED

MeSH Terms

Interventions

donafenibSorafenib

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Shukui Qin, MD

    The PLA 81 Hospital

    STUDY CHAIR

  • Feng Bi, MD

    West China Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Masking Details
open-label
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2015

First Posted

January 5, 2016

Study Start

March 1, 2016

Primary Completion

November 27, 2019

Study Completion

December 17, 2019

Last Updated

January 9, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)