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Brief Title: Lipotecan Based Concurrent Chemoradiotherapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
Official Title: A Phase I/II, Dose-escalation Study of Lipotecan Based Concurrent Chemoradiotherapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
Study ID: NCT03035006
Brief Summary: This is a phase I/II dose-escalation study of lipotecan based concurrent chemoradiotherapy in hepatocellular carcinoma with portal vein tumor thrombosis.
Detailed Description: Protocol number: TLCTLC388A1008 Primary objective: To evaluate the safety and tolerability, including maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), of Lipotecan based concurrent chemoradiotherapy (CCRT) in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT) unsuitable for local treatment. Secondary Objective: The secondary objective is to explore the efficacy of Lipotecan based CCRT in patients with HCC and PVTT and the effect on quality of life.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hosipital, Taipei, , Taiwan
Taipei Veteran General Hospital, Taipei, , Taiwan
Name: Carl Brown, PhD
Affiliation: Taiwan Liposome Company
Role: STUDY_DIRECTOR