Liver Cancer HepaSphere Combined With Cryosurgery
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: HepaSphere combined with cryosurgery liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)combined with cryosurgery |
Procedure: HepaSphere combined with cryosurgery
liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)combined with cryosurgery
|
Placebo Comparator: control liver cancer patients received traditional therapy |
Procedure: HepaSphere combined with cryosurgery
liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)combined with cryosurgery
|
Outcome Measures
Primary Outcome Measures
- Number of participants with Adverse events [1 year]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age:18-80
-
Karnofsky performance status >60
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Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures.
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Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
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Will receive interventional therapy
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Life expectancy: Greater than 3 months
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Patients' routine blood test, liver function and kidney function have no obvious abnormalities
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Ability to understand the study protocol and a willingness to sign a written informed consent document
Exclusion Criteria:
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Patients with other primary tumor except liver cancer
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History of coagulation disorders or anemia
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Central laboratory in Fuda cancer hospital | Guangzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Fuda Cancer Hospital, Guangzhou
Investigators
- Study Chair: Lizhi Niu, PhD, Fuda Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Liver hepaSphere cryosurgery