HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Pancreatic Cancer
1 other identifier
interventional
N/A
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）for pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2015
Longer than P75 for phase_1 pancreatic-cancer
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
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 12, 2015
CompletedFirst Posted
Study publicly available on registry
May 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedSeptember 12, 2019
August 1, 2015
3.1 years
May 12, 2015
September 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with Adverse events
1 year
Secondary Outcomes (3)
Percentage of lesions that show no sign of recurrence 12 months after interventional therapy
1 year
Progress free disease (PFS)
1 year
Overall survival (OS)
3 year
Study Arms (2)
HepaSphere
EXPERIMENTALpancreatic cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
control
NO INTERVENTIONpancreatic cancer patients did not receive any interventional therapy
Interventions
pancreatic cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
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 pancreatic 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
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lizhi Liu, 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
May 12, 2015
First Posted
May 21, 2015
Study Start
May 1, 2015
Primary Completion
June 1, 2018
Study Completion
June 1, 2020
Last Updated
September 12, 2019
Record last verified: 2015-08