Back to resultsApplication of Intrahepatic Arterial Infusion Chemotherapy for Patients With High Risk of Liver Metastases After Pancreatic Cancer Surgery
Primary Purpose
Pancreatic Ductal Adenocarcinoma, Who Have High CTCs Count in Portal Venous Blood, Liver Metastases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intrahepatic Arterial Infusion
Sponsored by
About this trial
This is an interventional prevention trial for Pancreatic Ductal Adenocarcinoma focused on measuring Pancreatic ductal adenocarcinoma, arterial infusion chemotherapy, liver metastases
Eligibility Criteria
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
Sites / Locations
- Department of General Surgery,Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intrahepatic Arterial Infusion chemotherapy
control
Arm Description
chemotherapy through intrahepatic arterial Infusion is one of the most widely used liver tumor treatments.
chemotherapy through Peripheral venous is one of the regularly used method.
Outcomes
Primary Outcome Measures
Death
Overall survival time after operation
Secondary Outcome Measures
Full Information
NCT ID
NCT03687853
First Posted
August 20, 2018
Last Updated
September 26, 2018
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03687853
Brief Title
Application of Intrahepatic Arterial Infusion Chemotherapy for Patients With High Risk of Liver Metastases After Pancreatic Cancer Surgery
Official Title
Application of Intrahepatic Arterial Infusion Chemotherapy for Patients With High Risk of Liver Metastases After Pancreatic Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Clinical results on intra-arterial adjuvant chemotherapy for prevention
of liver metastasis following curative resection of pancreatic cancer
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Ductal Adenocarcinoma, Who Have High CTCs Count in Portal Venous Blood, Liver Metastases
Keywords
Pancreatic ductal adenocarcinoma, arterial infusion chemotherapy, liver metastases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pancreatic cancer patients who received hepatic arterial perfusion chemotherapy after operation
Masking
Participant
Masking Description
Pancreatic cancer patients who received chemotherapy through peripheral vein after operation
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intrahepatic Arterial Infusion chemotherapy
Arm Type
Experimental
Arm Description
chemotherapy through intrahepatic arterial Infusion is one of the most widely used liver tumor treatments.
Arm Title
control
Arm Type
No Intervention
Arm Description
chemotherapy through Peripheral venous is one of the regularly used method.
Intervention Type
Device
Intervention Name(s)
Intrahepatic Arterial Infusion
Intervention Description
Intrahepatic Arterial Infusion chemotherapy is one of the most widely used liver tumor treatments.
Primary Outcome Measure Information:
Title
Death
Description
Overall survival time after operation
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dianrong xiu, doctor
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of General Surgery,Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Application of Intrahepatic Arterial Infusion Chemotherapy for Patients With High Risk of Liver Metastases After Pancreatic Cancer Surgery
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