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Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT01932385
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Youxin Ji, Qingdao Central Hospital

Brief Summary:
Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class A patients, but the result for Child-Pugh class B patients is unclear.

Condition or disease Intervention/treatment Phase
Liver Cancer Drug: Sorafenib Other: Best Supportive Care Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Sorafenib in the Management of Liver Function Impaired Advanced Hepatocellular Carcinoma
Study Start Date : August 1, 2013
Actual Primary Completion Date : January 30, 2016
Actual Study Completion Date : July 30, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sorafenib
sorafenib 400mg, oral, twice a day until disease progression defined by RECIST.
Drug: Sorafenib
Other Name: Nexavar

Other: Best Supportive Care
Active Comparator: Best Supportive Care
treatment mainly on nutrition and symptoms control
Other: Best Supportive Care



Primary Outcome Measures :
  1. progression free survival and overall survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause up to 12 months ]

Secondary Outcome Measures :
  1. response rate [ Time Frame: every 4 weeks till progression, total up to 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pathological or cytological confirmed advanced hepatocellular carcinoma
  • 18 years to 80 years
  • liver function Child-Pugh class B
  • BCLC stage B or C
  • estimated life time 2 months or longer

Exclusion Criteria:

  • previous target therapy
  • allergy to Sorafenib
  • Uncontrolled Bleeding or diarrhea
  • eligible for locoregional treatment

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): NCT01932385


Locations
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China, Shandong
Qingdao Central Hospital, Qingdao Cancer Hospital
Qingdao, Shandong, China, 266042
Sponsors and Collaborators
Qingdao Central Hospital
Investigators
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Study Director: ketao lan, M.D. Qingdao Health Bereau

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Responsible Party: Youxin Ji, Chief, Department of Oncology, Qingdao Central Hospital
ClinicalTrials.gov Identifier: NCT01932385     History of Changes
Other Study ID Numbers: QCH20130823
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: October 2015

Keywords provided by Youxin Ji, Qingdao Central Hospital:
Sorafenib
Hepatocellular carcinoma
Best supportive care
Survival

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action