• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Delcath’s phase II liver cancer trial shows promising results

Delcath’s phase II liver cancer trial shows promising results

August 22, 2011
CenterWatch Staff

Delcath Systems has reported encouraging top-line results from the hepatobiliary cohort of the phase II clinical trial of the Delcath chemosaturation system with melphalan in the treatment of patients with unresectable liver cancer.

This study, conducted at the National Cancer Institute, included four patient cohorts: hepatobiliary cancers, and metastatic cancers of neuroendocrine, ocular or cutaneous melanoma, and colorectal (adenocarcinoma) origins.

There were nine patients with tumors of hepatobiliary origin: five hepatocellular carcinomas (HCC) and four cholangiocarcinomas.  HCC is the most common primary cancer of the liver, with approximately 500,000 new cases diagnosed worldwide annually. Both groups had positive efficacy signals. The responses were especially encouraging in the HCC cohort and consisted of confirmed partial response or durable stable disease.  The safety profile of the chemosaturation system was consistent with that previously reported for the company's phase III melanoma trial.

The trial's primary objectives were to determine the response rate and duration of response to intrahepatic infusion of melphalan with subsequent venous hemofiltration.  Secondary objective measures included patterns of recurrence, progression-free survival and overall survival.  Additional secondary objectives were to evaluate safety and tolerability in this patient population, and assess filter characteristics including melphalan pharmacokinetics and filtration of cytokines and clotting factors.

    Upcoming Events

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 25Oct

      2023 WCG Patient Forum

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Donna Snyder

      New WCG Executive Physician Outlines Goals for Clinical Research

    • Hand Shake at Meeting

      Partnership to Bolster Trials in Low Resource Regions Kicks Off

    • Guidelines-360x240.png

      Major Industry Groups Offer Feedback on ICH’s E6(R3) Guidelines

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Monitoring

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing