Delcath PHP-HCC-202 study, v6
Research type
Research Study
Full title
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
IRAS ID
173195
Contact name
Johnny John
Contact email
Sponsor organisation
Delcath Systems, Inc
Eudract number
2014-001585-98
Research summary
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. It will be conducted as an open-label study because there will be no comparators. Approximately up to 42 patients with unresectable HCC or ICC confined to liver will be enrolled In the first stage, 11 patients with HCC and 11 patients with ICC will be accrued. If there are ≤ 3 responses in the 11 patients with HCC, treatment in that cohort will be stopped. Otherwise, 20 additional patients will be accrued into the HCC cohort for a total of 31 patients with HCC. If 14 or more responses are observed in 31 patients with HCC, the conclusion will be that the therapy is worthy of further investigation. The study will be conducted at approximately 12 centers. Primary objective: To estimate the objective response rate (ORR) of Melphalan/Hepatic Delivery System (HDS)treatment in patients with unresectable hepatocellular carcinoma (HCC) or intra-hepatic cholangiocarcinoma (ICC) confined to the liver.
Secondary objectives: To evaluate the safety of melphalan administered by Melphalan/Hepatic Delivery System (HDS) To assess the progression free survival (PFS) of patients receiving Melphalan/Hepatic Delivery System (HDS)
Method: The Percutaneous hepatic perfusion (PHP) system is used to deliver an intensive local hepatic dose of chemotherapy in which melphalan hydrochloride is delivered intra-arterially to the liver with simultaneous extra-corporeal filtration of the hepatic venous blood return to remove melphalan in the blood before it is returned to the systemic circulation.
Dosage: Melphalan 3.0 mg/kg IBW will be administered by PHP. Selection of the melphalan dose of 3.0 mg/kg IBW was based upon the activity and safety data observed in patients treated in the Phase 2 study, 04-C-0273, and the Phase 1, dose-escalation study, 01-C-0215.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
15/SC/0633
Date of REC Opinion
14 Dec 2015
REC opinion
Further Information Favourable Opinion