Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma

A Multicenter, Open-label, Non-randomized, Dose-escalation, Therapeutic Exploratory Trial to Evaluate the Safety and Efficacy of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma

The purpose of this study is:

Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy

Inclusion Criteria:

• Patients with histopathologically or clinically confirmed diagnosis of hepatocellular carcinoma
• Patients with Child-Pugh classification A or B
• Patients unresponsive to standard therapy or for whom standard therapy is intolerable, or for whom there is no appropriate therapy
• Patients who are able to take oral medication
• Patients age 20 to 79 years (inclusive) at time of informed consent
• Patients with an ECOG performance status score of 0-2
• Patients have the eligible organ function.

Exclusion Criteria:

• Patients with a primary malignant tumor
• Patients with a history of liver transplant
• Patients with brain metastases
• Patients with a complication of uncontrolled
• Patients with a psychiatric disorder that might cause difficulty in obtaining informed consent or in conducting the trial