- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03687853
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
-
-
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.
|
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
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
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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