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Trial record 37 of 2838 for:    Pancreatic Cancer

Nano Drug Interventional Therapy Using Digital Subtraction Angiography(DSA) for Pancreatic Carcinoma

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: NCT02449135
Recruitment Status : Completed
First Posted : May 20, 2015
Last Update Posted : February 25, 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 nano drug interventional therapy using digital subtraction angiography(DSA) for pancreatic cancer. The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection.

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 nano drug interventional therapy using digital subtraction angiography(DSA)for pancreatic cancer.

The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection. The nano drug's size is detected by laser diffraction particle size analyzer.


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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: Nano Drug Interventional Therapy Using Digital Subtraction Angiography(DSA) for Pancreatic Carcinoma:Clinical Trial
Study Start Date : May 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nano drug
Pancreatic cancer patients received nano drug interventional therapy using digital subtraction angiography(DSA). The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection.
Procedure: interventional therapy
Pancreatic cancer patients received drug interventional therapy using the digital subtraction angiography(DSA).

Active Comparator: Drug microspheres
Pancreatic cancer patients received drug microspheres (HepaSphere Microspheres) interventional therapy using digital subtraction angiography(DSA).
Procedure: interventional therapy
Pancreatic cancer patients received drug interventional therapy using the digital subtraction angiography(DSA).

No Intervention: Control
Pancreatic cancer patients never received 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

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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 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): NCT02449135


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: NCT02449135     History of Changes
Other Study ID Numbers: Nano drug pancreatic cancer
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: June 2015

Keywords provided by Fuda Cancer Hospital, Guangzhou:
Pancreatic Cancer
Nano drug

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases