NCT02267213

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of TLC388 (Lipotecan) as a second line treatment in subjects with advanced Hepatocellular Carcinoma.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_2 hepatocellular-carcinoma

Geographic Reach
2 countries

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2015

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

September 11, 2014

Last Update Submit

February 23, 2019

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Disease Control Rate (DCR)

    DCR (Disease control rate), the percentage of subjects with a best response rate of complete response (CR), partial response (PR), or stable disease (SD)

    8 weeks from initial treatment

Secondary Outcomes (13)

  • Objective response rate (ORR; where ORR= CR rate + PR rate)

    8 weeks(Cycle 2), 16 weeks (Cycle 4), 24 weeks (Cycle 6) from initial treatment and/or Early termination (before 24 weeks)

  • Duration of Disease control (DDC)

    2 months (Cycle 2), 4 months (Cycle 4) and 6 months (Cycle 6) and/or Early termination (before 6 months)

  • Time to Progression (TTP)

    2 months (Cycle 2), 4 months (Cycle 4) and 6 months (Cycle 6) and/or Early termination (before 6 months)

  • Progression Free Survival (PFS)

    2 months (Cycle 2), 4 months (Cycle 4) and 6 months (Cycle 6) and/or Early termination (before 6 months)

  • Overall Survival (OS)

    Up to 2 years from the last treatment of the last subject

  • +8 more secondary outcomes

Study Arms (1)

Lipotecan

EXPERIMENTAL

Administer 40mg of Lipotecan at D1, D8, D15 of each cycles.

Drug: Lipotecan

Interventions

LipotecanDRUG

Administer 40mg Lipotecan at D1, D8, D15 of each cycle.

Also known as: Lipotecan, TLC388
Lipotecan

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Radiological diagnosis of hepatic tumor(s) by contrast-enhanced study
  • Subjects with advanced HCC who are not eligible for surgical resection or loco-regional therapy.
  • Subjects with sorafenib treatment failure due to sorafenib intolerance or radiographic PD (as per RECIST v1.1). Prior sorafenib use should be ≥ 400 mg/day for at least 14 days.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Child Pugh Score ≤ 6;
  • A life expectancy of at least 12 weeks or more

You may not qualify if:

  • Subjects who have received any systemic target therapy or systemic chemotherapy other than sorafenib for the treatment of HCC.
  • Subjects who have received sorafenib within 2 weeks prior to the initiation of the treatment dose, or have any sorafenib-related toxicities not yet resolved to grade 1 or baseline.
  • Subjects who have undergone liver transplantation surgery.
  • Major surgery within 4 weeks prior to the initiation of the treatment dose (excluding implantation of the intravenous infusion device). Percutaneous liver puncture within 2 weeks prior to the initiation of the treatment dose.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

307 Hospital of PLA

Beijin, 100071, China

Location

Nanjing Bayi Hospital

Nanjing, 210002, China

Location

Shanghai Cancer Hospital, Fudan University

Shanghai, 200032, China

Location

Zhongshan Hospital, Fudan University

Shanghai, 200032, China

Location

Chiayi Chang Gung Memorial Hosipital

Chiayi City, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

China Medical University Hosipital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Mackay Memorial Hosipital

Taipei, Taiwan

Location

National Taiwan University Hosipital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

LinKou Chang Gung Memorial Hosipital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

TLC 388

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Yunlong Tseng

    Taiwan Liposome Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2014

First Posted

October 17, 2014

Study Start

April 10, 2014

Primary Completion

July 9, 2015

Study Completion

July 9, 2015

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

TW(8)CN(4)