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

Primary Purpose

Carcinoma, Hepatocellular

Status
Terminated
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Lipotecan® (TLC388)
Sponsored by
Taiwan Liposome Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring HCC, PVTT

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mackay Memorial Hospital
  • Taipei Veteran General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lipotecan® (TLC388)

Arm Description

Dosage form: 40mg TLC388 base/vial lyophilized cake Dose: Chemotherapy, i.v. q.w. x 6 doses (dose-escalation) * The dosage regimen would be escalated gradually until MTD had been found out.

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD)
Maximum tolerated dose
PVTT response rate
PVTT response rate
Dose-limiting toxicity (DLT)
Dose-limiting toxicity
Adverse Event/Serious Adverse Event
Serious/ Adverse Event

Secondary Outcome Measures

Hepatic tumor response rate (overall tumor response rate)
Hepatic tumor response rate (overall tumor response rate)
Tumor downstaging rate
Tumor downstaging rate
Time to progression (TTP)
Time to progression
Progression-free survival (PFS)
Progression-free survial
Overall survival (OS)
Overall survival
Change from baseline in tumor marker/biomarkers
Change from baseline in tumor marker/biomarkers

Full Information

First Posted
August 15, 2011
Last Updated
August 20, 2018
Sponsor
Taiwan Liposome Company
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1. Study Identification

Unique Protocol Identification Number
NCT01425996
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Study Start Date
October 27, 2011 (Actual)
Primary Completion Date
October 3, 2014 (Actual)
Study Completion Date
October 3, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiwan Liposome Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
HCC, PVTT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lipotecan® (TLC388)
Arm Type
Experimental
Arm Description
Dosage form: 40mg TLC388 base/vial lyophilized cake Dose: Chemotherapy, i.v. q.w. x 6 doses (dose-escalation) * The dosage regimen would be escalated gradually until MTD had been found out.
Intervention Type
Drug
Intervention Name(s)
Lipotecan® (TLC388)
Other Intervention Name(s)
Lipotecan (TLC388)
Intervention Description
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
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD)
Description
Maximum tolerated dose
Time Frame
week 12
Title
PVTT response rate
Description
PVTT response rate
Time Frame
week7
Title
Dose-limiting toxicity (DLT)
Description
Dose-limiting toxicity
Time Frame
week 12
Title
Adverse Event/Serious Adverse Event
Description
Serious/ Adverse Event
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Hepatic tumor response rate (overall tumor response rate)
Description
Hepatic tumor response rate (overall tumor response rate)
Time Frame
week7, week12
Title
Tumor downstaging rate
Description
Tumor downstaging rate
Time Frame
week7, week12
Title
Time to progression (TTP)
Description
Time to progression
Time Frame
week7, week12, 1 year
Title
Progression-free survival (PFS)
Description
Progression-free survial
Time Frame
week7, week12, 1 year
Title
Overall survival (OS)
Description
Overall survival
Time Frame
week7, week12, 1year
Title
Change from baseline in tumor marker/biomarkers
Description
Change from baseline in tumor marker/biomarkers
Time Frame
week4, week7, week12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsang-En Wa, MD
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yee Chao, MD
Organizational Affiliation
Taipei Veteran General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chen-Hsi Hsieh, MD
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacqueline Whang-Peng, MD
Organizational Affiliation
Wan Fang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veteran General Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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