Application of Intrahepatic Arterial Infusion Chemotherapy for Patients With High Risk of Liver Metastases After Pancreatic Cancer Surgery

September 26, 2018 updated by: Peking University Third Hospital

Clinical results on intra-arterial adjuvant chemotherapy for prevention

of liver metastasis following curative resection of pancreatic cancer

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study, the investigator try to select 80 patients who received radical surgery for pancreatic cancer, whose circulating tumor cells(CTCs) count then performed on intraoperative portal venous blood to predict postoperative liver metastasis and were divided into two groups. for those who have high CTCs count may have more chance for the occurrence of postoperative liver metastasis was applied hepatic arterial perfusion chemotherapy with minimal dynamic randomization. The aim is to evaluate the feasibility of hepatic arterial infusion chemotherapy for the prevention of postoperative liver metastasis and improvement of prognosis of pancreatic cancer, so as to further improve postoperative management of pancreatic cancer

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Department of General Surgery,Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pancreatic cancer patients who received the radical operation

Exclusion Criteria:

  • who accepted chemotherapy before operation or who cannot or do not will to accepted enrolled into this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intrahepatic Arterial Infusion chemotherapy
chemotherapy through intrahepatic arterial Infusion is one of the most widely used liver tumor treatments.
Device: Intrahepatic Arterial Infusion
Intrahepatic Arterial Infusion chemotherapy is one of the most widely used liver tumor treatments.
NO_INTERVENTION: control
chemotherapy through Peripheral venous is one of the regularly used method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: up to 12 months
Overall survival time after operation
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Study Chair: dianrong xiu, doctor, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ANTICIPATED)

December 31, 2018

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

August 20, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (ACTUAL)

September 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAI PDCA 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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