Status:
TERMINATED
Efficacy and Safety Study of TLC388 to Advanced Hepatocellular Carcinoma
Lead Sponsor:
Taiwan Liposome Company
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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.
Detailed Description
A Phase II, open-label, single-arm, two-stage, multicenter study to evaluate the efficacy and safety of Lipotecan® monotherapy in patients with advanced hepatocellular carcinoma (HCC) and had failed s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 10 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02267213
Start Date
April 10 2014
End Date
July 9 2015
Last Update
February 26 2019
Active Locations (12)
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1
307 Hospital of PLA
Beijin, China, 100071
2
Nanjing Bayi Hospital
Nanjing, China, 210002
3
Shanghai Cancer Hospital, Fudan University
Shanghai, China, 200032
4
Zhongshan Hospital, Fudan University
Shanghai, China, 200032