NCT02523404CompletedPhase 1
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Lung Cancer: Clinical Trial
Fuda Cancer Hospital, Guangzhou1 site in 1 country60 target enrollmentStarted: May 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of participants with Adverse events
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Karnofsky performance status >60
- •Diagnosis of lung 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
Exclusion Criteria
- •Patients with other primary tumor except lung cancer
- •History of coagulation disorders or anemia
Arms & Interventions
HepaSphere
Experimental
lung cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
Intervention: interventional therapy (Procedure)
control
Placebo Comparator
lung cancer patients received traditional therapy
Intervention: interventional therapy (Procedure)
Outcomes
Primary Outcomes
Number of participants with Adverse events
Time Frame: 1 year
Secondary Outcomes
- Progress free disease (PFS)(1 year)
- Percentage of lesions interventional therapy that show no sign of recurrence 12 months after(1 year)
- Overall survival (OS)(3 year)
Investigators
Study Sites (1)
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