Hepatic Artery Infusion (HAI) Program at Duke University

NCT04511793 | Withdrawn FDA Device

• 1 other identifier: Pro00106190
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Colon Cancer; Liver Cancer; Intrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Number of patients Treated

  Number of patients who completed HAI therapy

  Surgery to 6 months post-surgery

Secondary Outcomes (1)

• Serious Adverse Events

  Surgery to one year post-surgery

Study Arms (1)

Hepatic Artery Infusion (HAI)

EXPERIMENTAL

The Medtronic Synchromed II pump with the Codman® Catheter will be used to create the investigational device. The Medtronic Synchromed II pump is a surgically implantable device that allows for the delivery of high doses of chemotherapy directly to the liver, in order to treat cancer. The device is surgically implanted into a subcutaneous pocket in the abdominal wall, and the catheter is inserted into the arterial system of the liver, allowing for chemotherapeutic delivery.

Device: Medtronic Synchromed II pump

Interventions

Medtronic Synchromed II pump DEVICE

The pump will be placed during surgery and the pump will be filled with a combination of floxuridine (FUDR), dexamethasone, heparin, and saline.

Hepatic Artery Infusion (HAI)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18-80
• Eastern Cooperative Oncology Group score 0-1
• Fit for major surgery
• Without evidence of cirrhosis or portal hypertension
• Labs within 14 days of surgery: White blood cells ≥3 k/uL, Absolute Neutrophil Count ≥ 1.5 k/uL, Platelets ≥ 100K /uL, Creatinine ≤ 1.5 mg/dL, Total bilirubin ≤1.5 mg/dL
• Disease should be liver-only or liver-dominant
• Arterial anatomy must be suitable, determined by the surgeon
• Primary tumor may be in place in the case of colorectal liver metastases. Patients may have colorectal liver metastases (unresectable, borderline resectable, resectable), or unresectable intrahepatic cholangiocarcinoma.
• Chemotherapy completed at least 3 weeks prior to surgery.

You may not qualify if:

• Patients younger than 18 or older than 80 years
• Eastern Cooperative Oncology Group score 2+
• Unfit for major surgery
• Inherent liver disease with evidence of cirrhosis or portal hypertension
• Widely metastatic disease is absolutely contraindicated
• Pregnant women (Women of childbearing potential who have not completed menopause, had a hysterectomy and/or both tubes and/or both ovaries removed and have a partner who is able to father children will have a blood or urine pregnancy test performed, and it must be negative in order to continue in the study.)

Sponsors & Collaborators

• Michael Lidsky, M.D.: lead

MeSH Terms

Conditions

Colonic Neoplasms; Liver Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Michael Lidsky, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 13, 2020
• Study Start: December 11, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share