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

Fuda Cancer Hospital, Guangzhou

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lung Cancer

Treatments: Procedure: interventional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02449122

Nano drug lung cancer

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Nano drug

Experimental group

Description:

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.

Treatment:

Procedure: interventional therapy

Drug MicroSpheres

Active Comparator group

Description:

Lung cancer patients received drug microspheres (HepaSphere Microspheres) interventional therapy using digital subtraction angiography（DSA）.

Treatment:

Procedure: interventional therapy

Control

No Intervention group

Description:

Liver cancer patients never received any interventional therapy.