Status:
TERMINATED
A Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma
Lead Sponsor:
Taiwan Liposome Company
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Radiotherapy (R/T) for locally advanced hepatocellular carcinoma (HCC) is often used in patient who is not suitable for transarterial chemoembolization (TACE) and other local therapy, especially in th...
Detailed Description
Lipotecan® is a drug product of TLC388 HCl, which is a potent camptothecin analog with cytotoxic activities against a variety of human tumor cell lines and anti-tumor activities in several xenograft m...
Eligibility Criteria
Inclusion
- Females or males 20-70 years of age (inclusive)
- Patients with histological confirmed HCC or other conditions
- Patients with locally advanced HCC and PVTT that is not suitable for other local therapies
- Other inclusion criteria also apply
Exclusion
- Females who are pregnant/lactating or planning to be pregnant, or patients of childbearing potential who are not using medically recognized method of contraception.
- Patients with documented extrahepatic metastasis
- Patients with stage III-IV encephalopathy or tense ascites
- Patients who have received any local or systemic therapy for HCC within 4 weeks prior to the initiation of study treatment
- Patients who have received Lipotecan® treatment prior to the initiation of study treatment
- Other exclusion criteria also apply
Key Trial Info
Start Date :
October 27 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01425996
Start Date
October 27 2011
End Date
October 3 2014
Last Update
August 21 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Mackay Memorial Hospital
Taipei, Taiwan
2
Taipei Veteran General Hospital
Taipei, Taiwan