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Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02645981
Recruitment Status : Completed
First Posted : January 5, 2016
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
Tigermed Consulting Co., Ltd
Information provided by (Responsible Party):
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary:
Donafenib versus sorafenib for advanced hepatocellular cancer.

Condition or disease Intervention/treatment Phase
HCC Drug: Donafenib Drug: Sorafenib Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 668 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: open-label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma: a Controlled,Multicentre,Randomised, Phase 3 Trial
Study Start Date : March 2016
Actual Primary Completion Date : November 27, 2019
Actual Study Completion Date : December 17, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arm Intervention/treatment
Experimental: Donafenib
Drug:Donafenib; Dose:200mg,bid,po.
Drug: Donafenib
Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects
Other Name: CM4307

Active Comparator: Sorafenib(Nexavar)
Drug:Sorafenib; Dose:400mg,bid,po.
Drug: Sorafenib
Control
Other Name: Nexavar




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years ]
    Patient visits are scheduled every 8 weeks to monitor efficacy.


Secondary Outcome Measures :
  1. Progress Free Survival [ Time Frame: 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)

  2. Percentage of adverse events [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645981


Locations
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China, Jiangsu
The PLA 81 Hospital
Nanjing, Jiangsu, China, 025
China, Sichuan
West China Hospital Sichuan University
Chengdu, Sichuan, China, 610042
Sponsors and Collaborators
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Tigermed Consulting Co., Ltd
Investigators
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Study Chair: Shukui Qin, MD The PLA 81 Hospital
Study Chair: Feng Bi, MD West China Hospital
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Responsible Party: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT02645981    
Other Study ID Numbers: ZGDH3
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Suzhou Zelgen Biopharmaceuticals Co.,Ltd:
Donafeinb
Sorafenib
Phase 3
Overall Survival
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action