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

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ClinicalTrials.gov Identifier: NCT02523430
Recruitment Status : Completed
First Posted : August 14, 2015
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

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

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Procedure: interventional therapy Phase 1 Phase 2

Detailed Description:
By enrolling patients with nasopharyngeal 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 nasopharyngeal carcinoma.

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Study Type : Interventional  (Clinical Trial)
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 Nasopharyngeal Carcinoma: Clinical Trial
Study Start Date : May 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HepaSphere
nasopharyngeal carcinoma patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)
Procedure: interventional therapy
nasopharyngeal carcinoma patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)

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




Primary Outcome Measures :
  1. Number of participants with Adverse events [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Percentage of lesions interventional therapy that show no sign of recurrence 12 months after [ Time Frame: 1 year ]
  2. Progress free disease (PFS) [ Time Frame: 1 year ]
  3. Overall survival (OS) [ Time Frame: 3 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523430


Locations
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China, Guangdong
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Investigators
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Study Chair: Lizhi Niu, PhD Fuda Cancer Hospital

Additional Information:
Publications:
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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02523430     History of Changes
Other Study ID Numbers: NPC HepaSphere
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: October 2015

Keywords provided by Fuda Cancer Hospital, Guangzhou:
Nasopharyngeal Carcinoma
HepaSphere

Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases