HepaSphere Interventional Therapy Using Digital Subtraction Angiography(DSA) for Cervical Carcinoma

Overview

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

Full Title of Study: “HepaSphere Interventional Therapy Using Digital Subtraction Angiography(DSA) for Cervical Carcinoma: Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2016

Detailed Description

By enrolling patients with cervical carcinoma 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 cervical carcinoma.

Interventions

  • Procedure: interventional therapy
    • cervical carcinoma patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)

Arms, Groups and Cohorts

  • Experimental: HepaSphere
    • cervical carcinoma patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)
  • Placebo Comparator: control
    • cervical carcinoma patients received traditional therapy

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with Adverse events
    • Time Frame: 1 year

Secondary Measures

  • Percentage of lesions interventional therapy that show no sign of recurrence 12 months after
    • Time Frame: 1 year
  • Progress free disease (PFS)
    • Time Frame: 1 year
  • Overall survival (OS)
    • Time Frame: 3 year

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fuda Cancer Hospital, Guangzhou
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lizhi Niu, PhD, Study Chair, Fuda Cancer Hospital

References

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.

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