Infusion System for Hepatic Cancer

Launched by RONALD DEMATTEO, M.D. · Dec 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver chemotherapy directly to the liver for patients with specific types of cancer: colorectal cancer that has spread to the liver or intrahepatic cholangiocarcinoma. The trial is using a special pump and catheter system designed to safely infuse a common chemotherapy drug directly into the liver. The main goal is to ensure that this system is safe for patients while also providing treatment.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of the cancers mentioned. They should either have cancer that cannot be surgically removed but can respond to chemotherapy or be scheduled for surgery with plans to receive chemotherapy afterward. If you join the study, you can expect to have the pump implanted and monitored for safety over a period of up to five years. This will include regular checks to make sure the pump is working properly and that there are no issues with the catheter. It's important to note that pregnant or breastfeeding individuals, as well as those with active infections, cannot participate in this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • Known active infection
• • Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial