Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Lung Carcinoma

• Sponsor: Fuda Cancer Hospital, Guangzhou (Other)
• Overall Status: Completed
• CT.gov ID: NCT02449122
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Duration (Months): 9.1
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of nano drug interventional therapy using digital subtraction angiography（DSA） for lung cancer. The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Procedure: interventional therapy	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 nano drug interventional therapy using digital subtraction angiography（DSA）for lung cancer.

The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection. The nano drug's size is detected by laser diffraction particle size analyzer.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Lung Carcinoma：Clinical Trial
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nano drug Lung cancer patients received nano drug interventional therapy using digital subtraction angiography（DSA）. The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection.	Procedure: interventional therapy; Lung cancer patients received drug interventional therapy using the digital subtraction angiography（DSA.）
Active Comparator: Drug MicroSpheres Lung cancer patients received drug microspheres (HepaSphere Microspheres) interventional therapy using digital subtraction angiography（DSA）.	Procedure: interventional therapy; Lung cancer patients received drug interventional therapy using the digital subtraction angiography（DSA.）
No Intervention: Control Liver cancer patients never received any interventional therapy.

Outcome Measures

Primary Outcome Measures

1. Number of participants with Adverse events [1 year]

Secondary Outcome Measures

1. Percentage of lesions that show no sign of recurrence 12 months after interventional therapy [1 year]

2. Progress free disease (PFS) [1 year]

3. Overall survival (OS) [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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:

• Related Info

Publications

• 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.

• Responsible Party: Fuda Cancer Hospital, Guangzhou
• ClinicalTrials.gov Identifier: NCT02449122
• Other Study ID Numbers: Nano drug lung cancer
• First Posted: May 20, 2015
• Last Update Posted: Feb 25, 2016
• Last Verified: Jun 1, 2015

• Keywords provided by Fuda Cancer Hospital, Guangzhou: Lung Cancer; Nano drug
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Feb 25, 2016