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

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

NCT02523404

Lung Cancer HepaSphere

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for lung cancer.

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 HepaSphere interventional therapy using digital subtraction angiography（DSA）for lung cancer.

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 2 patient groups, including a placebo group

HepaSphere

Experimental group

Description:

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

Treatment:

Procedure: interventional therapy

control

Placebo Comparator group

Description:

lung cancer patients received traditional therapy

Treatment:

Procedure: interventional therapy