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

NCT ID: NCT02447263

Last Updated: 2016-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-02-29

Brief Summary

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

Detailed Description

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

Conditions

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Liver Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HepaSphere

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

Group Type EXPERIMENTAL

interventional therapy

Intervention Type PROCEDURE

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

control

liver cancer patients did not receive any interventional therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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interventional therapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fuda Cancer Hospital, Guangzhou

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lizhi Liu, PhD

Role: STUDY_CHAIR

Fuda Cancer Hospital

Locations

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Central laboratory in Fuda cancer hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 23806858 (View on PubMed)

Related Links

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Other Identifiers

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Liver Cancer HepaSphere

Identifier Type: -

Identifier Source: org_study_id

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