Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer

Air Force Military Medical University, China90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Unresectable Pancreatic Cancer

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, China

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, China

Outcomes

Primary Outcomes

overall surviva

Time frame: 36 months

Secondary Outcomes

Clinical Benefit Rate

Time frame: 12 months

The median progression-free survival PFS

Time frame: 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.

Time frame: 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.