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Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer
Conditions
Unresectable Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
Pancreatic cancer, Intra-arterial infusion, Gemcitabine
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: regional interventional chemotherapy group
Type: Procedure
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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
Locations
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, China
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Status: Not yet recruiting
Contact: GuoHong Han, MD - 86-29-84775221 - hangh@fmmu.edu.cn
Xi`an, Shaanxi, China
Status:
Start Date
August 2012
Completion Date
February 2016
Sponsors
Fourth Military Medical University
Source
Fourth Military Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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