Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer

Not Applicable

• Conditions: Unresectable Pancreatic Cancer
• Interventions: Procedure: regional interventional chemotherapy group

• Registration Number: NCT01665625
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-15
• Status Verified: 2012-08
• Study Start: 2012-08
• Study First Submitted QC: 2012-08-10
• Last Update Submitted: 2012-08-10
• Study First Posted: 2012-08-15
• Last Update Posted: 2012-08-15
• Primary Completion: 2015-08
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
regional interventional chemotherapy group	regional interventional chemotherapy group	-

Primary Outcome Measures

Name	Time	Method
overall surviva	36 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China