Melphalan for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma
NCT02415036 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2022-10-17
Summary
This is a two arm, open label, multi-center, Phase 2 study to evaluate the efficacy and safety of Melphalan/HDS in patients with unresectable Hepatocellular Carcinoma (HCC) or Intra Hepatic Cholangiocarcinoma (ICC) confined to the liver.
Conditions
- Hepatocellular Carcinoma
- Intrahepatic Cholangiocarcinoma
Interventions
- DEVICE
-
Delcath Hepatic Delivery System
- DRUG
-
Melphalan
Sponsors & Collaborators
-
Delcath Systems Inc.
lead INDUSTRY
Principal Investigators
-
Johnny John, MD · Delcath Systems
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-06-30
- Primary Completion
- 2018-10-31
- Completion
- 2018-12-31
Countries
- Germany
Study Locations
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