drugset / Trial / NCT01425996

A Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma

NCT01425996 ↗

Phase 1/2 Terminated 3 enrolled Taiwan Liposome Company
SequentialOpen-labelTreatment

Summary

Radiotherapy (R/T) for locally advanced hepatocellular carcinoma (HCC) is often used in patient who is not suitable for transarterial chemoembolization (TACE) and other local therapy, especially in those with portal vein tumor thrombosis (PVTT) caused by tumor cells. Several previous studies have showed that local R/T is tolerable and can induce a substantial tumor response in HCC management. In addition, the safety, toxicity and preliminary efficacy of Lipotecan® (TLC388) has also been proved in patients with terminal malignancy. This study aims to evaluate the safety, tolerability and efficacy of concomitant Lipotecan® and radiotherapy in patients with locally advanced HCC and PVTT.

Timeline

Start
2011-10-27
Primary completion
2014-10-03
Completion
2014-10-03

Drugs

EvaluationDrugModalityDoseRoute
Subject TLC388 Small molecule 15 mg/m2 Intravenous
Subject TLC388 Small molecule 30 mg/m2 Intravenous
Subject TLC388 Small molecule 40 mg/m2 Intravenous
Subject TLC388 Small molecule 50 mg/m2 Intravenous