NCT03687853

Brief Summary

Clinical results on intra-arterial adjuvant chemotherapy for prevention of liver metastasis following curative resection of pancreatic cancer

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

August 20, 2018

Last Update Submit

September 26, 2018

Conditions

Pancreatic Ductal AdenocarcinomaWho Have High CTCs Count in Portal Venous BloodLiver Metastases

Keywords

Pancreatic ductal adenocarcinomaarterial infusion chemotherapyliver metastases

Outcome Measures

Primary Outcomes (1)

  • Death

    Overall survival time after operation

    up to 12 months

Study Arms (2)

Intrahepatic Arterial Infusion chemotherapy

EXPERIMENTAL

chemotherapy through intrahepatic arterial Infusion is one of the most widely used liver tumor treatments.

Device: Intrahepatic Arterial Infusion

control

NO INTERVENTION

chemotherapy through Peripheral venous is one of the regularly used method.

Interventions

Intrahepatic Arterial InfusionDEVICE

Intrahepatic Arterial Infusion chemotherapy is one of the most widely used liver tumor treatments.

Intrahepatic Arterial Infusion chemotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pancreatic cancer patients who received the radical operation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General Surgery,Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Study Officials

  • dianrong xiu, doctor

    Peking University Third Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Pancreatic cancer patients who received chemotherapy through peripheral vein after operation
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Pancreatic cancer patients who received hepatic arterial perfusion chemotherapy after operation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2018

First Posted

September 27, 2018

Study Start

January 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

September 27, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)