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

Phase 1

Completed

• Conditions: Liver Cancer
• Interventions: Procedure: interventional therapy

• Registration Number: NCT02449109
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Brief Summary

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

Detailed Description

By enrolling patients with liver 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 liver 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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-14
• Study First Submitted QC: 2015-05-15
• Study First Posted: 2015-05-20
• Status Verified: 2015-06
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age:18-80
2. Karnofsky performance status >60
3. Diagnosis of liver 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 liver cancer
2. History of coagulation disorders or anemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nano drug	interventional therapy	Liver cancer patients received nano drug interventional therapy using digital subtraction angiography（DSA）. The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection.
Drug microspheres	interventional therapy	Liver cancer patients received drug microspheres (HepaSphere Microspheres) interventional therapy using digital subtraction angiography（DSA）.

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse events	1 year

Secondary Outcome Measures

Name	Time	Method
Percentage of lesions that show no sign of recurrence 12 months after interventional therapy	1 year
Progress free disease (PFS)	1 year
Overall survival (OS)	1 year

Trial Locations

Locations (1)

Central laboratory in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China