Efficacy and Safety Study of TLC388 to Advanced Hepatocellular Carcinoma

• Status: Terminated
• Trial end date: 2015-07-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of TLC388 (Lipotecan) as a second line treatment in subjects with advanced Hepatocellular Carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiwan Liposome Company
• Collaborator: Quintiles, Inc.

Criteria

Inclusion Criteria:

• Radiological diagnosis of hepatic tumor(s) by contrast-enhanced study

• Subjects with advanced HCC who are not eligible for surgical resection or loco-regional therapy.

• Subjects with sorafenib treatment failure due to sorafenib intolerance or radiographic PD (as per RECIST v1.1). Prior sorafenib use should be ≥ 400 mg/day for at least 14 days.

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

• Child Pugh Score ≤ 6;

• A life expectancy of at least 12 weeks or more

Exclusion Criteria:

• Subjects who have received any systemic target therapy or systemic chemotherapy other than sorafenib for the treatment of HCC.

• Subjects who have received sorafenib within 2 weeks prior to the initiation of the treatment dose, or have any sorafenib-related toxicities not yet resolved to grade 1 or baseline.

• Subjects who have undergone liver transplantation surgery.

• Major surgery within 4 weeks prior to the initiation of the treatment dose (excluding implantation of the intravenous infusion device). Percutaneous liver puncture within 2 weeks prior to the initiation of the treatment dose.