NCT01425996

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

A Phase I/II, Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Taiwan Liposome Company · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Lipotecan® is a drug product of TLC388 HCl, which is a potent camptothecin analog with cytotoxic activities against a variety of human tumor cell lines and anti-tumor activities in several xenograft models with human tumor cell lines. Structurally, TLC388 HCl is related to other camptothecins, but it has been chemically modified to improve stability and potency, and to minimize toxicities.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Lipotecan® (TLC388)	* Cohort A1: TLC388 15 mg/m2 x 6 dose + 3DCRT * Cohort A2: TLC388 30 mg/m2 x 6 dose + 3DCRT * Cohort A3: TLC388 40 mg/m2 x 6 dose + 3DCRT * Cohort A4: TLC388 50 mg/m2 x 6 dose + 3DCRT (dose-escalation) * Cohort A"x": TLC388 "MTD" x 6 dose + 3DCRT

Timeline

• Start date: 2011-10-27
• Primary completion: 2014-10-03
• Completion: 2014-10-03
• First posted: 2011-08-30
• Last updated: 2018-08-21

Locations

2 sites across 1 country: Taiwan