Status:
ACTIVE_NOT_RECRUITING
Infusion System for Hepatic Cancer
Lead Sponsor:
Ronald DeMatteo, M.D.
Conditions:
Colorectal Cancer Metastatic to Liver
Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a single-site, open-label continued access study/treatment protocol under a treatment IDE. In addition to treating patients, the primary objective of this study is to assess the safety of usin...
Eligibility Criteria
Inclusion
- Patients must be greater than or equal to 18 years of age
- Have a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to liver or intrahepatic cholangiocarcinoma
- At the time of pump placement, patients will either have unresectable, chemotherapy-responsive disease or they will be undergoing resection with planned postoperative HAI
- Be deemed appropriate for pump chemotherapy by both a medical oncologist and a surgical oncologist
- Provision of signed and dated informed consent form
Exclusion
- Known active infection
- Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04684862
Start Date
February 8 2021
End Date
July 1 2029
Last Update
December 15 2025
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104