HepaSphere Interventional Therapy Using Digital Subtraction Angiography(DSA)for Lung Cancer
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)for lung cancer.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
By enrolling patients with lung 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 lung cancer.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: HepaSphere lung cancer patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA) |
Procedure: interventional therapy
lung cancer patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)
|
Placebo Comparator: control lung cancer patients received traditional therapy |
Procedure: interventional therapy
lung cancer patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)
|
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:
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Age:18-80
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Karnofsky performance status >60
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Diagnosis of lung 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 lung 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
- Lung Cancer HepaSphere