Unresectable Pancreatic Cancer
Conditions
Keywords
Pancreatic cancer, Intra-arterial infusion, Gemcitabine
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.
Interventions
PROCEDUREregional interventional chemotherapy group
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.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall surviva | 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactJun Tie, PH.D., MD
Outcome results
None listed