Colorectal Cancer Metastatic to LiverNCT04684862
Infusion System for Hepatic Cancer
A study testing Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System) in people with Colorectal Cancer Metastatic to Liver and Intrahepatic Cholangiocarcinoma, run by Ronald DeMatteo, M.D. at 1 site in United States.
Trial 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 using the Medtronic SynchroMed II programmable pump combined with the Intera tapered catheter for hepatic artery infusion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic to Liver, Intrahepatic Cholangiocarcinoma
- What is being tested?
- Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2021to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known active infection
- Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Combined Infusion System to Deliver Chemotherapy Regionally to the Liver
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 using the Medtronic SynchroMed II programmable pump combined with the Intera tapered catheter for hepatic artery infusion (HAI) of a standard chemotherapy (FUDR) drug for adults with a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to the liver or intrahepatic cholangiocarcinoma.
After successful implantation, the combined pump and catheter system will be evaluated using a nuclear scan in the postoperative period, which is standard procedure to confirm that the pump is functioning prior to HAI of FUDR. Monitoring for safety will include a record of residual pump volume when it is emptied (every 2-12 weeks depending on whether the pump is being used for chemotherapy infusion) to determine if the pump is still working and surveillance of routine cross-sectional imaging (usually every 2-6 months) for any sign of a pump or catheter problem. Patients will be monitored for the safety of the pump/catheter combination for up to 5 years or pump removal/study withdrawal.
- Being tested
- Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System)
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System)Device
This infusion system is composed of a Medtronic SynchroMed II programmable pump connected to a Intera tapered catheter. Specifically, the Medtronic pump comes with a small connector that ends in a metal flange. During the operation, under sterile conditions, the distal 1 cm of the flange is severed using a scissor. Then, using a Intera connector pin, the end of the Medtronic catheter is connected to the Intera catheter . Two 2-0 silk ties secure the catheters to the pin. The pump and catheter are then inserted into the patient into the abdominal wall or into the chest wall. The catheter is inserted into an artery within the abdomen (usually the gastroduodenal artery but it depends on the exact arterial branching in the individual patient) that feeds the liver.
| Study group | Role | What they receive |
|---|---|---|
| Hepatic Artery Infusion (HAI) Therapy | Experimental | Eligible patients will be implanted with a device that combines components of two commercially available drug delivery pumps to administer regional chemotherapy (FUDR) to the liver. Specifically, a Medtronic pump is being used with an Intera tapered catheter, instead of the Medtronic catheter. Receives: Device: Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Targeted Adverse Events (TAEs)
TAEs are defined as AEs deemed related to the combination of the devices (i.e., the connection between the Medtronic pump and Intera Catheter).
Measured: From surgery up to 60 months post-surgery or study withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start8 Feb 2021
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Metastatic to LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ronald DeMatteo, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ronald DeMatteo, M.D., Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684862
- Sponsor's protocol ID
- UPCC 19220
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2020
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Infusion System to Deliver Chemotherapy Regionally to the Liver
- ClinicalTrials.gov ID
- NCT04684862
- Acronym / sponsor ID
- UPCC 19220
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ronald DeMatteo, M.D.University, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 using the Medtronic SynchroMed II programmable pump combined with the Intera tapered catheter for hepatic artery infusion (HAI) of a standard chemotherapy (FUDR) drug for adults with a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to the liver or intrahepatic cholangiocarcinoma.
After successful implantation, the combined pump and catheter system will be evaluated using a nuclear scan in the postoperative period, which is standard procedure to confirm that the pump is functioning prior to HAI of FUDR. Monitoring for safety will include a record of residual pump volume when it is emptied (every 2-12 weeks depending on whether the pump is being used for chemotherapy infusion) to determine if the pump is still working and surveillance of routine cross-sectional imaging (usually every 2-6 months) for any sign of a pump or catheter problem. Patients will be monitored for the safety of the pump/catheter combination for up to 5 years or pump removal/study withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatic Artery Infusion (HAI) Therapy | Experimental | Device: Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System)Eligible patients will be implanted with a device that combines components of two commercially available drug delivery pumps to administer regional chemotherapy (FUDR) to the liver. Specifically, a Medtronic pump is being used with an Intera tapered catheter, instead of the Medtronic catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Known active infection
- Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System)This infusion system is composed of a Medtronic SynchroMed II programmable pump connected to a Intera tapered catheter. Specifically, the Medtronic pump comes with a small connector that ends in a metal flange. During the operation, under sterile conditions, the distal 1 cm of the flange is severed using a scissor. Then, using a Intera connector pin, the end of the Medtronic catheter is connected to the Intera catheter . Two 2-0 silk ties secure the catheters to the pin. The pump and catheter are then inserted into the patient into the abdominal wall or into the chest wall. The catheter is inserted into an artery within the abdomen (usually the gastroduodenal artery but it depends on the exact arterial branching in the individual patient) that feeds the liver. | Device | Hepatic Artery Infusion (HAI) Therapy |
Primary outcome
Number of Targeted Adverse Events (TAEs)
Time frame: From surgery up to 60 months post-surgery or study withdrawal
TAEs are defined as AEs deemed related to the combination of the devices (i.e., the connection between the Medtronic pump and Intera Catheter).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System) in people with Colorectal Cancer Metastatic to Liver and Intrahepatic Cholangiocarcinoma, run by Ronald DeMatteo, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Targeted Adverse Events (TAEs) (time frame: From surgery up to 60 months post-surgery or study withdrawal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.