CHOLANGIOCARCINOMA: Metastatic: Liver dominant disease: Hepatic Perfusion: PHP-ICC-203

Randomized, controlled study to compare the efficacy, safety and pharmacokinetics of melphalan/HDS treatment given sequentially following cisplatin/gemcitabine versus cisplatin/gemcitabine in patients with intrahepatic cholangiocarcinoma

Title
Delcath PHP-ICC-203 (cholangioCA)
Study Title

Randomized, controlled study to compare the efficacy, safety and pharmacokinetics of melphalan/HDS treatment given sequentially following cisplatin/gemcitabine versus cisplatin/gemcitabine in patients with intrahepatic cholangiocarcinoma

Site Link
Malignancy
Cholangiocarcinoma, bile duct cancer, intrahepatic cholangiocarcinoma
Stage
Disease Setting
Unresectable or Metastatic
Line Of Therapy
Any line
Investigational Agent
Melphalan/HDS by percutaneous hepatic perfusion
Drug Class
chemotherapy perfusion
PI
Evan Glazer, MD
Sponsor
Delcath Systems, Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Intrahepatic cholangiocarcinoma diagnosed by histology
  • Unresectable disease
  • Less than 50% of liver involved
  • No clinically significant extra-hepatic disease (regional nodes 2cm or less are acceptable)
  • ECOG PS 0-1
  • No history of liver transplantation
  • Hepatic vasculature must be compatible with perfusion (prior Whipple is allowed only if anatomy is compatible)
  • No prior radiation therapy to the liver (including Y-90, I-131, etc.)
  • No prior treatment with percutanous trans-arterial treatment to liver (such as TAE or TACE)
  • No Class II or higher CHF
  • No prior malignancy within 5 years except in-situ disease or non-melanoma skin cancer
  • No active HBV or HCV
  • No CNS disease
  • Plts >100, Hgb >10 (independent of transfusions), ANC >1500
  • Bili <1.5x normal, ALT/AST <5x normal 
Objective

Primary- OS

Secondary- PFS, ORR, QoL, PK, safety

Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Cholangiocarcinoma
Dosing Frequency
Control Agents
cisplatin/gemcitabine
Study Protocol
Randomized
Yes
X