NCT01665625

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2012

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

Enrollment Period

3 years

First QC Date

July 15, 2012

Last Update Submit

August 10, 2012

Conditions

Unresectable Pancreatic Cancer

Keywords

Pancreatic cancerIntra-arterial infusionGemcitabine

Outcome Measures

Primary Outcomes (1)

  • overall surviva

    36 months

Secondary Outcomes (4)

  • Clinical Benefit Rate

    12 months

  • The median progression-free survival PFS

    12 months

  • Drug Toxicity

    18 months

  • surgical complications

    18 months

Study Arms (2)

regional interventional chemotherapy group

EXPERIMENTAL
Procedure: regional interventional chemotherapy group

systemic chemotherapy

NO INTERVENTION

Interventions

regional interventional chemotherapy groupPROCEDURE

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.

regional interventional chemotherapy group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or lactating women
  • Uncontrolled internal diseases
  • Past or the presence of other malignancy
  • Those who had received immunosuppressive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • Han GH, Yin ZX, Meng XJ, He CY, Zhang HB, Sun AH, Wu KC, Ding J, Fan DM. Prospective randomized clinical trial of two drug delivery pathway in the treatment of inoperable advanced pancreatic carcinoma. Chin J Dig Dis. 2006;7(1):45-8. doi: 10.1111/j.1443-9573.2006.00243.x.

    PMID: 16412037BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Guohong Han, MD

    Xijing Hospital of Digestive Diseases, Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Tie, PH.D., MD

CONTACT

+86-29-84771528tiejun7776@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Digestive Interventional Radiology

Study Record Dates

First Submitted

July 15, 2012

First Posted

August 15, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2015

Study Completion

February 1, 2016

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations

CN(2)