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Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1

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ClinicalTrials.gov Identifier: NCT02129322
Recruitment Status : Not yet recruiting
First Posted : May 2, 2014
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Weijia Fang, Zhejiang University

Brief Summary:
The study is designed to investigate the effect of adjuvant therapy by Sorafenib, Oxaliplatin and S-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver transplantation

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Sorafenib Drug: S-1 Drug: Oxaliplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1o Prevent the Tumor Recurrence for Hepatocellular Carcinoma After Liver Transplantation: A Randomized Controlled Study
Study Start Date : July 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sorafenib
Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance
Drug: Sorafenib
Drug: S-1
Drug: Oxaliplatin
Experimental: S-1 and Sorafenib
Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance
Drug: Sorafenib
Drug: S-1
Drug: Oxaliplatin



Primary Outcome Measures :
  1. Time to Recurrence (TTR) [ Time Frame: within five years after liver transplantation ]
    Time to Recurrence


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: within the five years after liver transplantation ]
    Overall survival


Other Outcome Measures:
  1. Circulative tumor cell (CTC) level change [ Time Frame: within one year after liver transplantation ]
    Circulative tumor cell



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hepatocellular carcinoma after liver transplantation
  • Major organ (heart, lung and brain) function was normal

Exclusion Criteria:

  • Any active infectious process
  • The presence of clinically confirmed extrahepatic metastasis
  • Postoperative dysfunction of any organ

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): NCT02129322


Contacts
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Contact: Weijia fang weijiafang@gmail.com

Locations
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China
First affiliated hospital, Zhejiang University Not yet recruiting
Hangzhou, China
Contact: Weijiafang fang         
Principal Investigator: Weijia fang, MD         
Sponsors and Collaborators
Zhejiang University
Investigators
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Principal Investigator: Weijia fang First Affiliated Hospital,Zhejiang University

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Responsible Party: Weijia Fang, First affiliated hospital, Zhejiang University, Zhejiang University
ClinicalTrials.gov Identifier: NCT02129322     History of Changes
Other Study ID Numbers: ZYYYMedOncoLT01
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015

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