Neoplasms

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Carcinoma, Hepatocellular

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Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

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Intrahepatic Cholangiocarcinoma

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Melphalan

Antineoplastic Agents, Alkylating

Alkylating Agents

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Percutaneous hepatic perfusion with melphalan hydrochloride for injection using the Hepatic Delivery System on patients with Hepatocellular carcinoma (HCC).

Melphalan hydrochloride is administered at a dose of 3mg/kg ideal body weight once every 6 weeks for a maximum of 2 cycles of treatment.

Percutaneous hepatic perfusion with melphalan hydrochloride for injection using the Hepatic Delivery System on patients with Intrahepatic cholangiocarcinoma (ICC).

Melphalan hydrochloride is administered at a dose of 3mg/kg ideal body weight once every 6 weeks for a maximum of 2 cycles of treatment.

Delcath Hepatic Delivery System

Johnny John, MD

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.

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 HCC or ICC confined to the liver.

Eligible patients will receive up to 2 Melphalan/HDS treatments. Each treatment cycle consists of 6 weeks with an acceptable delay for another 2 weeks before next planned treatment. Tumor response will be assessed at the end of cycle 2.

The Melphalan/HDS treatment will be terminated in patients with progressive disease (PD) after the 1st treatment and based on safety in patients with \> 8 weeks delay of recovery from toxicity.

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

An International Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Melphalan Hydrochloride for Injection for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma

Delcath Systems Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Melphalan for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma	NCT02415036	Hepatocellular ... Intrahepatic Ch...	Delcath Hepatic... Melphalan	18 Years -	Delcath Systems Inc.
Melphalan for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma	NCT02415036	Hepatocellular ... Intrahepatic Ch...	Delcath Hepatic... Melphalan	18 Years -	Delcath Systems Inc.

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