West Cancer Center

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

Site Link

NCT03086993

Malignancy

Cholangiocarcinoma, bile duct cancer, intrahepatic cholangiocarcinoma

Stage

Stage 4

Disease Setting

Unresectable or Metastatic

Line Of Therapy

Any line

Investigational Agent

Melphalan/HDS by percutaneous hepatic perfusion

Drug Class

chemotherapy perfusion

Evan Glazer, MD

Sponsor

Delcath Systems, Inc.

Phase

Phase 3

Status

Closed to Accrual

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

Assessment Frequency Link

Path

Cholangiocarcinoma

Dosing Frequency

Control Agents

cisplatin/gemcitabine

Study Protocol

Randomized

Yes