Safety Issues Clinical Trial
Official title:
A Multi-center, Open-label, Randomized Phase II Clinical Study to Evaluate the Efficacy and Safety of I.V.Infusion of MB07133 in Patients With Unresectable HCC
A randomized, open, multicenter clinical trial design was adopted, planned to be conducted in three stages, with 91 participants expected to be included in the study to evaluate the efficacy, tolerance, and safety of different doses of MB07133 in the treatment of unresectable advanced primary liver cancer.
first stage：The investigators plan to recruit 20 cases for mid dose group exploration: the injection MB07133600mg/m2/day group and the 1200mg/m2/day group, with 10 cases recruited for each group. The treatment cycle is 28 days, with each dose group receiving 7 days of medication and 21 days of rest per cycle. second stage：Based on the data results of the first stage, the 1200mg/m2/day dose group MB07133 was selected for further expansion, with the same administration method as the first stage. Plan to recruit 30 subjects. third stage：Based on the treatment results of H201110LC3, the 1800mg/m2/day dose group was selected for further expansion, and 40 subjects were recruited with the same administration method as the first stage. ;
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