Liver Cancer HepaSphere Combined With Cryosurgery
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）Combined With Cryosurgery for Liver Cancer: Clinical Trial
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 8, 2015
CompletedFirst Posted
Study publicly available on registry
September 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 29, 2016
October 1, 2015
1 year
September 8, 2015
August 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with Adverse events
1 year
Secondary Outcomes (3)
Percentage of lesions interventional therapy that show no sign of recurrence 12 months after
1 year
Progress free disease (PFS)
1 year
Overall survival (OS)
3 year
Study Arms (2)
HepaSphere combined with cryosurgery
EXPERIMENTALliver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery
control
PLACEBO COMPARATORliver cancer patients received traditional therapy
Interventions
liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with other primary tumor except liver cancer
- History of coagulation disorders or anemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, 510000, China
Related Publications (1)
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.
PMID: 23806858BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lizhi Niu, PhD
Fuda Cancer Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2015
First Posted
September 10, 2015
Study Start
August 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 29, 2016
Record last verified: 2015-10