Hepatocellular Carcinoma (HCC) Clinical Trial
Official title:
An International Multi-center Phase 2 Study to Evaluate the Safety and Efficacy of Sequential Melphalan Hydrochloride for Injection for Use With the Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable Hepatocellular Carcinoma
This is a single arm, open label, multi-center, phase 2 study to evaluate the safety and efficacy of sequential treatment with Melphalan/HDS followed by sorafenib in patients with unresectable hepatocellular carcinoma (HCC) confined to the liver.
This is a single arm, open label, multi-center, phase 2 study to evaluate the safety and
efficacy of sequential treatment with Melphalan/HDS followed by sorafenib in patients with
unresectable hepatocellular carcinoma (HCC) confined to the liver.
Eligible patients will receive up to 3 Melphalan/HDS treatments. Each treatment cycle
consists of 6 weeks with an acceptable delay for another 2 weeks before next planned
treatment. The Melphalan/HDS treatment will be terminated in patients with progressive
disease (PD), complete response (CR), and > 8 weeks delay of recovery from toxicity after
last PHP treatment.
With the exception of patients with PD, all patients will be treated with sorafenib after
completing the Melphalan/HDS treatment. Patients with PD will be managed with standard of
care off-study by their treating physician.
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