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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
interventional therapy
Sponsored by
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung Cancer, HepaSphere

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age:18-80
  2. Karnofsky performance status >60
  3. Diagnosis of lung cancer based on histology or the current accepted radiological measures.
  4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
  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 lung cancer
  2. History of coagulation disorders or anemia

Sites / Locations

  • Central laboratory in Fuda cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HepaSphere

control

Arm Description

lung cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）

lung cancer patients received traditional therapy

Outcomes

Primary Outcome Measures

Number of participants with Adverse events

Secondary Outcome Measures

Percentage of lesions interventional therapy that show no sign of recurrence 12 months after
Progress free disease (PFS)
Overall survival (OS)

Full Information

First Posted
August 12, 2015
Last Updated
August 26, 2016
Sponsor
Fuda Cancer Hospital, Guangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT02523404
Brief Title
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）for Lung Cancer
Official Title
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Lung Cancer: Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer, HepaSphere

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HepaSphere
Arm Type
Experimental
Arm Description
lung cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
lung cancer patients received traditional therapy
Intervention Type
Procedure
Intervention Name(s)
interventional therapy
Intervention Description
lung cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
Primary Outcome Measure Information:
Title
Number of participants with Adverse events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Percentage of lesions interventional therapy that show no sign of recurrence 12 months after
Time Frame
1 year
Title
Progress free disease (PFS)
Time Frame
1 year
Title
Overall survival (OS)
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age:18-80 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lizhi Niu, PhD
Organizational Affiliation
Fuda Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Central laboratory in Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23806858
Citation
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/25937772
Description
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HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）for Lung Cancer

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