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

Study Overview
=================
Brief Summary
-----------------
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

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.

Official Title
-----------------
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

Conditions
-----------------
Hepatic Malignant Neoplasm Primary Non-Resectable

Participation Criteria
=================
Eligibility Criteria
-----------------
Have received CHEMOSAT treatment per IFU within the last 6-months or are planned to receive treatment with CHEMOSAT. Have provided written informed consent according to institutional and regulatory guidelines
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

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] |