Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02449967
Recruitment Status : Withdrawn
First Posted : May 21, 2015
Last Update Posted : September 12, 2019
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 pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: interventional therapy Phase 1 Phase 2

Detailed Description:
By enrolling patients with pancreatic 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 pancreatic cancer.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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 Pancreatic Cancer: Clinical Trial
Study Start Date : May 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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

No Intervention: control
pancreatic cancer patients did not receive any interventional therapy



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

Secondary Outcome Measures :
  1. Percentage of lesions that show no sign of recurrence 12 months after interventional therapy [ 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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

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): NCT02449967


Locations
Layout table for location information
China, Guangdong
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Investigators
Layout table for investigator information
Study Chair: Lizhi Liu, PhD Fuda Cancer Hospital

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02449967     History of Changes
Other Study ID Numbers: Pancreatic Cancer HepaSphere
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: August 2015
Keywords provided by Fuda Cancer Hospital, Guangzhou:
Pancreatic Cancer
HepaSphere
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases