Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Unresectable Pancreatic Cancer

Treatments: Procedure: regional interventional chemotherapy group

Study type: Interventional

Funder types: Other

Identifiers

NCT01665625

XHDD 003

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

regional interventional chemotherapy group

Experimental group

Treatment:

Procedure: regional interventional chemotherapy group

systemic chemotherapy

No Intervention group