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Liver Cancer HepaSphere Combined With Cryosurgery

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: 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

Tracking Information
First Submitted Date  ICMJE September 8, 2015
First Posted Date  ICMJE September 10, 2015
Last Update Posted Date August 29, 2016
Study Start Date  ICMJE August 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2015)		 Number of participants with Adverse events [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2015)
  • Percentage of lesions interventional therapy that show no sign of recurrence 12 months after [ Time Frame: 1 year ]
  • Progress free disease (PFS) [ Time Frame: 1 year ]
  • Overall survival (OS) [ Time Frame: 3 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liver Cancer HepaSphere Combined With Cryosurgery
Official Title  ICMJE HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）Combined With Cryosurgery for Liver Cancer: Clinical Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Cancer
Intervention  ICMJE Procedure: HepaSphere combined with cryosurgery
liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery
Study Arms  ICMJE
  • Experimental: HepaSphere combined with cryosurgery
    liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery
    Intervention: Procedure: HepaSphere combined with cryosurgery
  • Placebo Comparator: control
    liver cancer patients received traditional therapy
    Intervention: Procedure: HepaSphere combined with cryosurgery
Publications * Niu L, Chen J, Yao F, Zhou L, Zhang C, Wen W, Bi X, Hu Y, Piao X, Jiang F, Zeng J, Liu W, Li J, He L, Mu F, Zuo J, Xu K. Percutaneous cryoablation for stage IV lung cancer: a retrospective analysis. Cryobiology. 2013 Oct;67(2):151-5. doi: 10.1016/j.cryobiol.2013.06.005. Epub 2013 Jun 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2015)		 60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02545556
Other Study ID Numbers  ICMJE Liver hepaSphere cryosurgery
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fuda Cancer Hospital, Guangzhou
Study Sponsor  ICMJE Fuda Cancer Hospital, Guangzhou
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lizhi Niu, PhD Fuda Cancer Hospital
PRS Account Fuda Cancer Hospital, Guangzhou
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP