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Ongoing Clinical Trials

Phase III Trial of ThermoDox® in Combinatioin with Radiofrequency Ablation in Unresectable Hepatocellular Carcinoma

Official Title A Phase III, Randomized, Double-Blinded, Dummy-Controlled Study of the Efficacy and Safety of ThermoDox® (Thermally Sensitive Liposomal Doxorubicin) in Combination with Radiofrequency Ablation (RFA) Compared to RFA-Alone in the Treatment of Non-Resectable Hepatocellular Carcinoma
Countries Global
Clinical Phase Phase III
Study Arm ThermoDox® combined with RFA
Arm 2: Placebo combined with RFA
Description

A significant number of patients with Hepatocellular Carcinoma (HCC) are not candidates for surgical resection. Radiofrequency ablation (RFA) is a new modality of treatment for unresectable HCC that has gained much enthusiasm in recent years. Ablation allows for the increased preservation of healthy liver tissue. While initial complete ablation rate is high, some patients develop local recurrence during follow-up. The addition of ThermoDox®, systemically delivered, heat-activated liposome encapsulated doxorubicin, to this ablation procedure has the potential to improve local control by the creation of high local concentrations of doxorubicin in the boundary of the ablation margin resulting in increased ablation volume and achieves better tumor cell kill in and around the tumor margin. The liposome encapsulation reduces systemic side effects of doxorubicin and Phase I trial showed that it was well-tolerated.

The main purpose of this study is to find out if ThermoDox® increases the effectiveness of RFA.

Age Eligible for study 18 years and older
Genders Eligible for Study Both
Key Inclusion Criteria
  1. Diagnosed hepatocellular carcinoma (HCC)
  2. No more than 4 HCC lesions with at least one 3cm and none > 7cm in maximum diameter
  3. Have preserved liver function
Key Exclusion Criteria
  1. Have previously received any treatment for HCC
  2. Have previously received any doxorubin
  3. Have extrahepatic disease
 
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