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Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01665625
Recruitment Status : Unknown
Verified August 2012 by Guohong Han, Fourth Military Medical University.
Recruitment status was:  Not yet recruiting
First Posted : August 15, 2012
Last Update Posted : August 15, 2012
Information provided by (Responsible Party):
Guohong Han, Fourth Military Medical University

Brief Summary:
Systemic chemotherapy with cytotoxic drug is of limited effectiveness in advanced pancreatic cancer patients. Gemcitabine has been used as the first-line drug for advance pancreatic cancer for over two decades and combinations of gemcitabine with different chemotherapeutic drugs have been investigated to improve the outcomes of pancreatic cancer. However, no substantial improvement in patient survival has been achieved. Locoregional chemotherapy via intra-arterial perfusion or chemoemoblization takes advantage of the increasing local drug concentrations and reducing systemic toxicities. In this study, the investigators hypothesis that artery infusion chemotherapy had a better antitumor effect than systemic chemotherapy. The investigators will analyze and evaluate the effect and safety of an implanted percutaneous left subclavian artery port-catheter drug delivery system for regional chemotherapy of inoperable pancreatic carcinoma.

Condition or disease Intervention/treatment
Unresectable Pancreatic Cancer Procedure: regional interventional chemotherapy group

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Regional Versus Systemic Continuous Gemcitabine Chemotherapy in the Treatment of Unresectable Pancreatic Cancer
Study Start Date : August 2012
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: regional interventional chemotherapy group Procedure: regional interventional chemotherapy group
The patients in experimental group were monitored by X-ray imaging. A 0.038 super-sliding guide wire was inserted after successful puncture, and when site of the pancreatic carcinoma was reconfirmed by conventional angiography, a 5F cobra catheter was used to place the port-catheter drug delivery system in the celiac artery (pancreatic head) or the hepatic artery (pancreatic body and tail). Finally, the port-catheter was embedded under the left upper chest.
No Intervention: systemic chemotherapy

Primary Outcome Measures :
  1. overall surviva [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Clinical Benefit Rate [ Time Frame: 12 months ]
  2. The median progression-free survival PFS [ Time Frame: 12 months ]
  3. Drug Toxicity [ Time Frame: 18 months ]
    The grading standards of the World Health Organization for acute and subacute toxicity of anticancer drugs will be used to grade toxicity.

  4. surgical complications [ Time Frame: 18 months ]
    Major surgical complications included allergic reaction to the contrast agent, local hematoma, pneumothorax, puncture site bleeding, wound infection, delayed healing or cracking, port-catheter blockage, and necrosis of the tissue surrounding the port-catheter.

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

Inclusion Criteria:

  • Signed written informed consent
  • Karnofsky score > 60,
  • Expected survival > 3 months,
  • Liver, kidney function and routine blood test within normal range
  • No serious cardiopulmonary dysfunction
  • No acute infection

Exclusion Criteria:

  • Pregnant or lactating women
  • Uncontrolled internal diseases
  • Past or the presence of other malignancy
  • Those who had received immunosuppressive therapy

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): NCT01665625

Contact: Jun Tie, PH.D., MD +86-29-84771528 tiejun7776@163.com

China, Shaanxi
Xijing Hospital of Digestive Diseases, Fourth Military Medical University Not yet recruiting
Xi'an, Shaanxi, China, 710032
Contact: GuoHong Han, MD    86-29-84775221    hangh@fmmu.edu.cn   
Sub-Investigator: Jun Tie, PH.D.,MD         
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi`an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Principal Investigator: Guohong Han, MD Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Responsible Party: Guohong Han, Head of Department of Digestive Interventional Radiology, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01665625     History of Changes
Other Study ID Numbers: XHDD 003
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 2012

Keywords provided by Guohong Han, Fourth Military Medical University:
Pancreatic cancer
Intra-arterial infusion

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs