Infusion system for treating liver cancer
Combined Infusion System to Deliver Chemotherapy Regionally to the Liver
This study tests a new pump and catheter system to see if it safely delivers chemotherapy directly to the liver for adults with colorectal cancer that has spread there or with liver cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04684862 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of a Medtronic SynchroMed II programmable pump combined with an Intera tapered catheter for hepatic artery infusion of chemotherapy in adults with colorectal cancer that has spread to the liver or intrahepatic cholangiocarcinoma. Patients will undergo implantation of the pump and catheter system, followed by monitoring to ensure proper function before chemotherapy administration. The study aims to provide continued access to this treatment while assessing its safety profile.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of colorectal cancer metastatic to the liver or intrahepatic cholangiocarcinoma who are appropriate for pump chemotherapy.
Not a fit: Patients with known active infections, those who are pregnant or breastfeeding, or those expecting to conceive during the trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with liver metastases from colorectal cancer or intrahepatic cholangiocarcinoma.
How similar studies have performed: While this specific approach is novel, similar infusion techniques have shown promise in treating liver cancers in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Ronald DeMatteo, MD
- Email: Ronald.DeMatteo@pennmedicine.upenn.edu
- Phone: 215-662-7539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.