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NCT02545556 Clinical Trial

Liver Cancer HepaSphere Combined With Cryosurgery

Liver Cancer Clinical Trial

Official title:
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）Combined With Cryosurgery for Liver Cancer: Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02545556
Other study ID # Liver hepaSphere cryosurgery
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 8, 2015
Last updated August 26, 2016
Start date August 2015
Est. completion date August 2016

Study information
Verified date October 2015
Source Fuda Cancer Hospital, Guangzhou
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
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）combined with cryosurgery for liver cancer.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
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 liver cancer

2. History of coagulation disorders or anemia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• HepaSphere combined with cryosurgery
liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)combined with cryosurgery

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 Yes
Secondary Percentage of lesions interventional therapy that show no sign of recurrence 12 months after 1 year No
Secondary Progress free disease (PFS) 1 year No
Secondary Overall survival (OS) 3 year No
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