Registry Protocol- Melphalan Percutaneous Hepatic Perfusion for the Treatment of Unresectable Hepatic Malignancy

Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP With the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy

Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP with the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy

Study Overview

• Status: Unknown
• Conditions: Hepatic Malignant Neoplasm Primary Non-Resectable

Detailed Description

Post Marketing study:

The CHEMOSAT kit containing Gen 2 filters has been used to treat patients since April 2012. This registry study is designed to collect safety, resource utilization and treatment outcomes in patients who receive this treatment with CHEMOSAT by healthcare professionals. The safety and efficacy data from patients treated with CHEMOSAT is important in updating the safety profile and for collection of treatment information. The resource utilization information is essential in planning treatment strategy for patients.

This registry does not follow any pre-determined protocol with respect to diagnosis, treatment or follow-up of the patient. The data collected will be gathered exclusively from current medical practice at participating institutions.

Delcath holds a list of authorized customer hospitals to whom it supplies the CHEMOSAT System. To date these hospitals have treated over 300 patients with cancers of the liver.

The decision to treat with CHEMOSAT is clearly separated from the decision to collect data in the registry. No specific procedures or tests are required in this protocol.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Leslie Callahan, BSN, MS; Phone Number: 247 212-489-2100; Email: lcallahan@delcath.com
• Study Contact Backup: Name: Nathalie Riebel, MBA; Phone Number: 238 212-489-2100; Email: nriebel@delcath.com

Study Locations

• United Kingdom
  • Southampton, United Kingdom
    • Recruiting
    • Southampton University Hospitals and University of Southampton
    • Contact: Ioannis Karydis, Dr.
  • Southampton, United Kingdom
    • Recruiting
    • Spire Southampton Hospital
    • Contact: Sanjay Gupta, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received or will receive treatment with CHEMOSAT for the Treatment of Unresectable Hepatic Malignancy

Description

1. Have received CHEMOSAT treatment per IFU within the last 6-months or are planned to receive treatment with CHEMOSAT.
2. Have provided written informed consent according to institutional and regulatory guidelines

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gather key safety data on the use of CHEMOSAT Kit (Gen 2 filter).	Data to be collected at: Baseline, treatment and post treatment laboratory values and clinical measurements until time of discharge	Post-procedure (up to 30 days after CS-PHP)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of treatment with CHEMOSAT each patient receives	The percentage of treatments with CHEMOSAT each patient receives based on primary tumor	From the first CHEMOSAT treatment through the last, [timeframe an average of 12-months if 6 cycles completed]
Evaluation of Best Overall Response	Evaluation of patient best overall response (partial response or complete response, when applicable)	from the date of first CHEMOSAT treatment through last CHEMOSAT treatment, or treatment discontinuation or death (whichever occurs first) [assessed up to 24 months]
Evaluation of resource utilization	Percentage of days spent in ICU, step-down area	From the first CHEMOSAT treatment through the last CHEMOSAT treatment [assessed up to 24 months]
Evaluate time to treatment failure	Time of first CHEMOSAT treatment to time of treatment failure	time from first CHEMOSAT treatment to the date of last CHEMOSAT treatment [assesed up to 24 months]

Collaborators and Investigators

• Sponsor: Delcath Systems Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2016
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: PHP-M-REG01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No