Clinical trial NCT01425996: A Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma
Official title: A Phase I/II, Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Hepatocellular
Keywords: HCC
PVTT
Lead sponsor: Taiwan Liposome Company
Sponsor class: INDUSTRY
First posted: 2011-08-30
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 those with portal vein tumor thrombosis (PVTT) caused by tumor cells. Several previous studies have showed that local R/T is tolerable and can induce a substantial tumor response in HCC management. In addition, the safety, toxicity and preliminary efficacy of Lipotecan® (TLC388) has also been proved in patients with terminal malignancy. This study aims to evaluate the safety, tolerability and efficacy of concomitant Lipotecan® and radiotherapy in patients with locally advanced HCC and PVTT.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: week 12
measure: PVTT response rate
timeFrame: week7
measure: Dose-limiting toxicity (DLT)
timeFrame: week 12
measure: Adverse Event/Serious Adverse Event
timeFrame: week 12
Secondary outcomes:
measure: Hepatic tumor response rate (overall tumor response rate)
timeFrame: week7, week12
measure: Tumor downstaging rate
timeFrame: week7, week12
measure: Time to progression (TTP)
timeFrame: week7, week12, 1 year
measure: Progression-free survival (PFS)
timeFrame: week7, week12, 1 year
measure: Overall survival (OS)
timeFrame: week7, week12, 1year
measure: Change from baseline in tumor marker/biomarkers
timeFrame: week4, week7, week12
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veteran General Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Tsang-En Wa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Veteran General Hospital
name: Yee Chao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Far Eastern Memorial Hospital
name: Chen-Hsi Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wan Fang Hospital
name: Jacqueline Whang-Peng, MD
role: PRINCIPAL_INVESTIGATOR
References: