A Phase I/II, Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma
20 Years
70 Years
Both
Carcinoma, Hepatocellular
Trial Information
A Phase I/II, Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma
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 models with human tumor cell lines. Structurally, TLC388 HCl is related
to other camptothecins, but it has been chemically modified to improve stability and
potency, and to minimize toxicities.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose (MTD)
Outcome Time Frame:
week 12
Safety Issue:
Yes
Principal Investigator
Tsang-En Wa, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mackay Memorial Hospital
Authority:
United States: Food and Drug Administration
Study ID:
TLC388.2
NCT ID:
NCT01425996
Start Date:
July 2011
Completion Date:
October 2015
Related Keywords:
- Carcinoma, Hepatocellular
- HCC
- PVTT
- Carcinoma
- Carcinoma, Hepatocellular
Name | Location |
|---|
