Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized Trial of Regional Versus Systemic Continuous Gemcitabine Chemotherapy in the Treatment of Unresectable Pancreatic Cancer

Conditions
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Unresectable Pancreatic Cancer

Intervention / Treatment
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* Procedure: regional interventional chemotherapy group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: regional interventional chemotherapy group<br> | Procedure: regional interventional chemotherapy group<br>* 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.<br>|
| No Intervention: systemic chemotherapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall surviva |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit Rate |  | 12 months | 
| The median progression-free survival PFS |  | 12 months | 
| Drug Toxicity | The grading standards of the World Health Organization for acute and subacute toxicity of anticancer drugs will be used to grade toxicity. | 18 months | 
| surgical complications | 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. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, Intra-arterial infusion, Gemcitabine