Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Taiwan Liposome Company
Sponsor:
Information provided by (Responsible Party):
Taiwan Liposome Company
ClinicalTrials.gov Identifier:
NCT01425996
First received: August 15, 2011
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: Lipotecan® (TLC388)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II, Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Taiwan Liposome Company:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
  • PVTT response rate [ Time Frame: week7 ] [ Designated as safety issue: No ]
  • dose-limiting toxicity (DLT) [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
  • Adverse Event/Serious Adverse Event [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hepatic tumor response rate (overall tumor response rate) [ Time Frame: week7, week12 ] [ Designated as safety issue: No ]
  • Tumor downstaging rate [ Time Frame: week7, week12 ] [ Designated as safety issue: No ]
  • Time to progression (TTP) [ Time Frame: week7, week12, 1 year ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: week7, week12, 1 year ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: week7, week12, 1year ] [ Designated as safety issue: No ]
  • Change from baseline in tumor marker/biomarkers [ Time Frame: week4, week7, week12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lipotecan® Drug: Lipotecan® (TLC388)
  • Cohort A1: TLC388 15 mg/m2 x 6 dose + 3DCRT
  • Cohort A2: TLC388 30 mg/m2 x 6 dose + 3DCRT
  • Cohort A3: TLC388 40 mg/m2 x 6 dose + 3DCRT
  • Cohort A4: TLC388 50 mg/m2 x 6 dose + 3DCRT (dose-escalation)
  • Cohort A"x": TLC388 "MTD" x 6 dose + 3DCRT

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425996

Locations
Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Tsang-En Wang, MD    +886-2-2543-3535 ext 3993      
Principal Investigator: Tsang-En Wang, MD         
Taipei Veteran General Hospital Recruiting
Taipei, Taiwan
Contact: Yee Chao, M.D.    +886-2-2875-7618      
Principal Investigator: Yee Chao, MD         
Sponsors and Collaborators
Taiwan Liposome Company
Investigators
Principal Investigator: Tsang-En Wa, MD Mackay Memorial Hospital
Principal Investigator: Yee Chao, MD Taipei Veteran General Hospital
Principal Investigator: Chen-Hsi Hsieh, MD Far Eastern Memorial Hospital
Principal Investigator: Jacqueline Whang-Peng, MD Wan Fang Hospital
  More Information

No publications provided

Responsible Party: Taiwan Liposome Company
ClinicalTrials.gov Identifier: NCT01425996     History of Changes
Other Study ID Numbers: TLC388.2
Study First Received: August 15, 2011
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration
Taiwan: Department of Health

Keywords provided by Taiwan Liposome Company:
HCC
PVTT

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2014