Clincosm LogoSign in Get a demo

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

Sponsor
Fuda Cancer Hospital, Guangzhou (Other)
Overall Status
Completed
CT.gov ID
NCT02523365
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
15
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: interventional therapy
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Cervical Carcinoma: Clinical Trial
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: HepaSphere

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

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

cervical carcinoma patients received traditional therapy

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants with Adverse events [1 year]

Secondary Outcome Measures

  1. Percentage of lesions interventional therapy that show no sign of recurrence 12 months after [1 year]

  2. Progress free disease (PFS) [1 year]

  3. Overall survival (OS) [3 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Central laboratory in Fuda cancer hospital Guangzhou Guangdong China 510000

Sponsors and Collaborators

  • Fuda Cancer Hospital, Guangzhou

Investigators

  • Study Chair: Lizhi Niu, PhD, Fuda Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier:
NCT02523365
Other Study ID Numbers:
  • Cervical Carcinoma HepaSphere
First Posted:
Aug 14, 2015
Last Update Posted:
Aug 29, 2016
Last Verified:
Oct 1, 2015
Keywords provided by Fuda Cancer Hospital, Guangzhou
Cervical Carcinoma
HepaSphere
Additional relevant MeSH terms:
Carcinoma

Study Results

No Results Posted as of Aug 29, 2016