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Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma

Primary Purpose

HCC

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Donafenib
Sorafenib
Sponsored by
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCC focused on measuring Donafeinb, Sorafenib, Phase 3, Overall Survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The PLA 81 Hospital
  • West China Hospital Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Donafenib

Sorafenib(Nexavar)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall Survival
Patient visits are scheduled every 8 weeks to monitor efficacy.

Secondary Outcome Measures

Progress Free Survival
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
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

Full Information

First Posted
December 31, 2015
Last Updated
January 7, 2020
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Collaborators
Tigermed Consulting Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02645981
Brief Title
Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma
Official Title
Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma: a Controlled,Multicentre,Randomised, Phase 3 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
November 27, 2019 (Actual)
Study Completion Date
December 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Collaborators
Tigermed Consulting Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCC
Keywords
Donafeinb, Sorafenib, Phase 3, Overall Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
open-label
Allocation
Randomized
Enrollment
668 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Donafenib
Arm Type
Experimental
Arm Description
Drug:Donafenib; Dose:200mg,bid,po.
Arm Title
Sorafenib(Nexavar)
Arm Type
Active Comparator
Arm Description
Drug:Sorafenib; Dose:400mg,bid,po.
Intervention Type
Drug
Intervention Name(s)
Donafenib
Other Intervention Name(s)
CM4307
Intervention Description
Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
Nexavar
Intervention Description
Control
Primary Outcome Measure Information:
Title
Overall Survival
Description
Patient visits are scheduled every 8 weeks to monitor efficacy.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progress Free Survival
Description
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)
Time Frame
2 years
Title
Percentage of adverse events
Description
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
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shukui Qin, MD
Organizational Affiliation
The PLA 81 Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Feng Bi, MD
Organizational Affiliation
West China Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
The PLA 81 Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
025
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610042
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma

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