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NCT02449967 Clinical Trial

HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Pancreatic Cancer: Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02449967
Other study ID # Pancreatic Cancer HepaSphere
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date May 2015
Est. completion date June 2020

Study information
Verified date August 2015
Source Fuda Cancer Hospital, Guangzhou
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

By enrolling patients with pancreatic 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）for pancreatic cancer.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2020
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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: ?,?,?

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 pancreatic cancer

2. History of coagulation disorders or anemia

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• interventional therapy
pancreatic cancer patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)

Locations
Country Name City State
China Central laboratory in Fuda cancer hospital Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Fuda Cancer Hospital, Guangzhou

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with Adverse events 1 year
Secondary Percentage of lesions that show no sign of recurrence 12 months after interventional therapy 1 year
Secondary Progress free disease (PFS) 1 year
Secondary Overall survival (OS) 3 year
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