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

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.

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.

Inclusion Criteria:

• Females or males 20-70 years of age (inclusive)
• Patients with histological confirmed HCC or other conditions
• Patients with locally advanced HCC and PVTT that is not suitable for other local therapies
• Other inclusion criteria also apply

Exclusion Criteria:

• Females who are pregnant/lactating or planning to be pregnant, or patients of childbearing potential who are not using medically recognized method of contraception.
• Patients with documented extrahepatic metastasis
• Patients with stage III-IV encephalopathy or tense ascites
• Patients who have received any local or systemic therapy for HCC within 4 weeks prior to the initiation of study treatment
• Patients who have received Lipotecan® treatment prior to the initiation of study treatment
• Other exclusion criteria also apply