Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT04511793
Status:
WITHDRAWN
Last Update Posted:
2021-07-19
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatic Artery Infusion (HAI) Program at Duke University
Sponsor:
Michael Lidsky, M.D.
Organization:
Study Overview
Official Title:
Hepatic Artery Infusion (HAI) Program at Duke University
Status:
WITHDRAWN
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No subjects enrolled due to availability of device commercially.
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Duke HAI program was implemented in November 2018 and treated 30 patients in its first 17 months using the Medtronic Synchromed II device (only commercially available device suitable for HAI for cancer patients). The Duke HAI program has demonstrated safety of HAI with an overall complication rate was 19%, similar to prior published data, with all but one complication (extrahepatic perfusion) salvaged. The Investigator has also demonstrated feasibility and efficacy of a new HAI program, with 95% of patients initiating therapy with promising hepatic response and disease control rates. This protocol will enable the team to continue this program. All eligible patients will receive the synchromed II pump with a Codman catheter and chemotherapy including FUDR, dexamethasone and heparin. Systemic chemotherapy will be given per standard of care.
Detailed Description:
This protocol is an interventional study for HAI therapy at Duke. The protocol is essentially for clinical treatment and the Investigator is not collecting safety and effectiveness data on the device itself. There are three primary indications for the hepatic artery infusion pump. The first are patients with unresectable, metastatic, liver-only or -dominant colorectal cancer. Although conversion to resection is a primary goal in these patients, most of these patients will die of liver disease and therefore controlling liver disease is a secondary goal to improve survival. The second group of patients are those with resectable, but high risk metastatic, liver-only or -dominant colorectal cancer. These patients are at high risk for liver recurrence, and HAI has demonstrated significant improvement in outcomes. The last group are patients with unresectable primary liver cancer, primarily intrahepatic cholangiocarcinoma. These patients have central tumors that are rarely resectable.
Eligible patients will have the following procedures performed during this study.
1. On the day of surgery, the Synchromed II pump will be implanted and the Codman® catheter placed for chemotherapy infusion.
2. During the hospital stay, patients will have:
* Daily physical examination to evaluate for the development of complications
* Daily blood tests to evaluate blood cell counts and liver function
* Initiation of a proton-pump inhibitor, if not already a home medication, which will continue indefinitely
* Assessment of side effects
Follow-Up Visits
Clinic visits and study activities will take place every 2 weeks after surgery, and include:
* Routine blood tests for blood cell counts, kidney function, and liver function
* Nuclear medicine SPECT/CT scan to confirm the pump and catheter are working properly. This is a type of scan where the images or pictures from two different types of scans are combined together.
* Start hepatic artery infusion (HAI) chemotherapy (at 2 week post-op).
HAI includes:
* Floxuridine (FUDR)
* Dexamethasone
* Heparin: (If heparin allergy, fondaparinux will be added)
* Normal saline
* Evaluation and treatment, including blood work and refilling the pump, every 2 weeks, until treatment is discontinued.
• Systemic chemotherapy (every 2 weeks after HAI started)
* Patients with metastatic colorectal cancer will receive systemic chemotherapy that will consist of either FOLFIRI, FOLFOX, or Irinotecan/oxaliplatin.
* Patients with cholangiocarcinoma will receive Gemcitabine/Oxaliplatin or Gemcitabine alone
When the chemotherapy regimen has completed, the Synchromed II pump will be reprogrammed every 4 weeks indefinitely.
Eligible patients will have the following procedures performed during this study.
1. On the day of surgery, the Synchromed II pump will be implanted and the Codman® catheter placed for chemotherapy infusion.
2. During the hospital stay, patients will have:
* Daily physical examination to evaluate for the development of complications
* Daily blood tests to evaluate blood cell counts and liver function
* Initiation of a proton-pump inhibitor, if not already a home medication, which will continue indefinitely
* Assessment of side effects
Follow-Up Visits
Clinic visits and study activities will take place every 2 weeks after surgery, and include:
* Routine blood tests for blood cell counts, kidney function, and liver function
* Nuclear medicine SPECT/CT scan to confirm the pump and catheter are working properly. This is a type of scan where the images or pictures from two different types of scans are combined together.
* Start hepatic artery infusion (HAI) chemotherapy (at 2 week post-op).
HAI includes:
* Floxuridine (FUDR)
* Dexamethasone
* Heparin: (If heparin allergy, fondaparinux will be added)
* Normal saline
* Evaluation and treatment, including blood work and refilling the pump, every 2 weeks, until treatment is discontinued.
• Systemic chemotherapy (every 2 weeks after HAI started)
* Patients with metastatic colorectal cancer will receive systemic chemotherapy that will consist of either FOLFIRI, FOLFOX, or Irinotecan/oxaliplatin.
* Patients with cholangiocarcinoma will receive Gemcitabine/Oxaliplatin or Gemcitabine alone
When the chemotherapy regimen has completed, the Synchromed II pump will be reprogrammed every 4 weeks indefinitely.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: