Back to resultsLiver Cancer HepaSphere Combined With Cryosurgery
Primary Purpose
Liver Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HepaSphere combined with cryosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring Liver Cancer, HepaSphere, cryosurgery
Eligibility Criteria
Inclusion Criteria:
- Age:18-80
- Karnofsky performance status >60
- Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures.
- Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
- Will receive interventional therapy
- Life expectancy: Greater than 3 months
- Patients' routine blood test, liver function and kidney function have no obvious abnormalities
- Ability to understand the study protocol and a willingness to sign a written informed consent document
Exclusion Criteria:
- Patients with other primary tumor except liver cancer
- History of coagulation disorders or anemia
Sites / Locations
- Central laboratory in Fuda cancer hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HepaSphere combined with cryosurgery
control
Arm Description
liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery
liver cancer patients received traditional therapy
Outcomes
Primary Outcome Measures
Number of participants with Adverse events
Secondary Outcome Measures
Percentage of lesions interventional therapy that show no sign of recurrence 12 months after
Progress free disease (PFS)
Overall survival (OS)
Full Information
NCT ID
NCT02545556
First Posted
September 8, 2015
Last Updated
August 26, 2016
Sponsor
Fuda Cancer Hospital, Guangzhou
1. Study Identification
Unique Protocol Identification Number
NCT02545556
Brief Title
Liver Cancer HepaSphere Combined With Cryosurgery
Official Title
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）Combined With Cryosurgery for Liver Cancer: Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Liver Cancer, HepaSphere, cryosurgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HepaSphere combined with cryosurgery
Arm Type
Experimental
Arm Description
liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
liver cancer patients received traditional therapy
Intervention Type
Procedure
Intervention Name(s)
HepaSphere combined with cryosurgery
Intervention Description
liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery
Primary Outcome Measure Information:
Title
Number of participants with Adverse events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Percentage of lesions interventional therapy that show no sign of recurrence 12 months after
Time Frame
1 year
Title
Progress free disease (PFS)
Time Frame
1 year
Title
Overall survival (OS)
Time Frame
3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age:18-80
Karnofsky performance status >60
Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures.
Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
Will receive interventional therapy
Life expectancy: Greater than 3 months
Patients' routine blood test, liver function and kidney function have no obvious abnormalities
Ability to understand the study protocol and a willingness to sign a written informed consent document
Exclusion Criteria:
Patients with other primary tumor except liver cancer
History of coagulation disorders or anemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lizhi Niu, PhD
Organizational Affiliation
Fuda Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Central laboratory in Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
23806858
Citation
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/25937772
Description
related information
Learn more about this trial
Liver Cancer HepaSphere Combined With Cryosurgery
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