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DELCATH SYSTEMS, INC. (DCTH)

Delcath Systems, Inc. is an interventional oncology firm operating in the United States and Europe, dedicated to developing treatments for both primary and secondary liver cancers. Its leading investigational product is the HEPZATO KIT, a unique hepatic delivery system for melphalan that targets high-dose chemotherapy specifically to the liver. This innovative approach aims to substantially reduce systemic drug exposure and mitigate associated side effects. HEPZATO's clinical evaluation is advancing through the FOCUS trial, which is designed to assess the objective response rate in individuals with metastatic uveal melanoma whose disease is primarily concentrated in the liver. Furthermore, the company offers a separate version of HEPZATO as a medical device in Europe, marketed under the CHEMOSAT Hepatic Delivery System brand (or simply CHEMOSAT). This system empowers European medical centers to manage a diverse array of liver cancer conditions. Delcath Systems, Inc. was established in 1988, with its corporate headquarters situated in New York, New York.

Sector: Surgical & Medical Instruments & Apparatus

Industry: Medical - Devices

Delcath Systems, Inc. logo

Delcath Systems, Inc.

NASDAQ:DCTHHealthcare
-4.10%$14.04
AH$13.85-1.35%vs close
Mkt Cap$487.17M
Float26.37M
O/S34.7M
Vol
$ Vol
RVOL
Inst Own50.3%
Earnings
Dilution
Delcath Systems, Inc. logoNASDAQ:DCTH$14.04-4.10%
Phase Distribution
11 lead-sponsored trials·3 active·3 completed
Phase 25
Phase 2/31
Phase 33
Not applicable2
(2 more as collaborator)
Status Overview
Recruiting2
Active, not recruiting1
Completed3
Stopped2
Expanded access1
Unknown2

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Completed

    Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma

    melphalan, regional chemotherapy

    Intraocular Melanoma, Melanoma (Skin) +1

    Enrollment
    93
    Start
    Feb 2006
    Primary Completion
    Aug 2012
    Completion
    Aug 2012
    NCT00324727
  • Phase 3
    Completed

    Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma

    Melphalan/HDS

    Ocular Melanoma, Uveal Melanoma

    Enrollment
    102
    Start
    Feb 2016
    Primary Completion
    May 2023
    Completion
    Aug 2023
    NCT02678572
  • Phase 3
    Active, not recruiting

    An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma

    Melphalan (3 mg/kg IBW) with Hepatic Delivery System (HDS)

    Metastatic Ocular Melanoma, Metastatic Uveal Melanoma

    Enrollment
    30
    Start
    Jun 2022
    Primary Completion
    Mar 2024est.
    Completion
    Mar 2024est.
    NCT05022901
  • Phase 2/3
    Unknown status

    Percutaneous Hepatic Perfusion vs. Cisplatin/Gemcitabine in Patients With Intrahepatic Cholangiocarcinoma

    Cisplatin and Gemcitabine

    Bile Duct Cancer, Intrahepatic Cholangiocarcinoma

    Enrollment
    295
    Start
    Apr 2018
    Primary Completion
    Jan 2023est.
    Completion
    May 2023est.
    NCT03086993
  • Phase 2
    Completed

    Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer

    isolated perfusion, melphalan

    Cancer

    Enrollment
    56
    Start
    Sep 2004
    Primary Completion
    Aug 2012
    Completion
    Aug 2012
    NCT00096083
  • Phase 2
    Withdrawn

    Sequential Melphalan for Use With Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable HCC

    Sorafenib

    Hepatocellular Carcinoma (HCC)

    Enrollment
    0
    Start
    Oct 2014
    Primary Completion
    Dec 2017
    Completion
    Dec 2017
    NCT02406508
  • Phase 2
    Terminated

    Melphalan for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma

    Melphalan

    Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma

    Enrollment
    17
    Start
    Jun 2014
    Primary Completion
    Oct 2018
    Completion
    Dec 2018
    NCT02415036
  • Phase 2
    Recruiting

    Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease

    Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab, Trifluridine-tipiracil plus Bevacizumab Alone

    Refractory Metastatic Colorectal Cancer

    Enrollment
    90
    Start
    Aug 2025
    Primary Completion
    Dec 2026est.
    Completion
    Oct 2027est.
    NCT06607458
  • Phase 2
    Recruiting

    Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Breast Cancer w/Liver Dominant Disease

    Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine), Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)

    Metastatic Breast Cancer in the Liver

    Enrollment
    90
    Start
    Jan 2026
    Primary Completion
    May 2029est.
    Completion
    Aug 2029est.
    NCT06875128
  • Expanded access
    No longer available

    Expanded Access Study of Melphalan With Delcath CS-PHP System in Patients With Ocular/Cutaneous Melanoma Mets to Liver

    Melphalan

    Metastatic Liver Cancer, Ocular Melanoma +1

    Enrollment
    -
    Start
    -
    Primary Completion
    -
    Completion
    -
    NCT01728051
  • Observational
    Unknown status

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

    -

    Hepatic Malignant Neoplasm Primary Non-Resectable

    Enrollment
    200
    Start
    Jan 2016
    Primary Completion
    Jan 2020est.
    Completion
    Feb 2020est.
    NCT03266042
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