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Liver Cancer HepaSphere Combined With Cryosurgery

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ClinicalTrials.gov Identifier: NCT02545556
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）combined with cryosurgery for liver cancer.

Condition or disease Intervention/treatment Phase
Liver Cancer Procedure: HepaSphere combined with cryosurgery Phase 1 Phase 2

Detailed Description:
By enrolling patients with liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA） combined with cryosurgery for liver cancer.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）Combined With Cryosurgery for Liver Cancer: Clinical Trial
Study Start Date : August 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: HepaSphere combined with cryosurgery
liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery
 Procedure: HepaSphere combined with cryosurgery
liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery
Placebo Comparator: control
liver cancer patients received traditional therapy
 Procedure: HepaSphere combined with cryosurgery
liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with Adverse events [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Percentage of lesions interventional therapy that show no sign of recurrence 12 months after [ Time Frame: 1 year ]
  2. Progress free disease (PFS) [ Time Frame: 1 year ]
  3. Overall survival (OS) [ Time Frame: 3 year ]

Eligibility Criteria
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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:

  1. Age:18-80
  2. Karnofsky performance status >60
  3. Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures.
  4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
  5. Will receive interventional therapy
  6. Life expectancy: Greater than 3 months
  7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
  8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

  1. Patients with other primary tumor except liver cancer
  2. History of coagulation disorders or anemia
Contacts and Locations
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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): NCT02545556


Locations
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China, Guangdong
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Investigators
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Study Chair: Lizhi Niu, PhD Fuda Cancer Hospital
More Information
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Additional Information:

Publications:

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02545556    
Other Study ID Numbers: Liver hepaSphere cryosurgery
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: October 2015
Keywords provided by Fuda Cancer Hospital, Guangzhou:
Liver Cancer
HepaSphere
cryosurgery
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases