drugset / Trial / NCT03086993

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

NCT03086993

Phase 2/3 Unknown 295 enrolled Delcath Systems Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate two groups of patients who have intrahepatic cholangiocarcinoma. Each group will receive induction treatment with Cisplatin and Gemcitabine per SOC for 4 treatment cycles. Following induction treatment patients will be randomize (1:1), to 2 arms of treatment. One group (50%) will be receive high dose chemotherapy delivered specifically to the liver, while the other group (50%) will continue treatment with Cisplatin and Gemcitabine. Patient in each group will get repeating cycles of treatment until the cancer advances. All patients will be followed until death. This study will compare the overall survival (OS) in patients with intrahepatic cholangiocarcinoma.

Timeline

Start
2018-04-10
Primary completion
2023-01
Completion
2023-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified 25 mg/m2
Comparator Gemcitabine Small molecule 1000 mg/m2
Subject Melphalan Small molecule 3 mg/kg