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Hepatocellular CarcinomaPhase 2NCT02267213

Efficacy and Safety Study of TLC388 to Advanced Hepatocellular Carcinoma

A Phase 2 study testing Lipotecan in people with Hepatocellular Carcinoma, run by Taiwan Liposome Company at 12 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Lipotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
12 sitesin 2 countries
Study dates
10 Apr 2014to 9 Jul 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Taiwan8 sites

  • Chiayi Chang Gung Memorial Hosipital

    Chiayi City

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City

  • China Medical University Hosipital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • Mackay Memorial Hosipital

    Taipei

  • National Taiwan University Hosipital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • LinKou Chang Gung Memorial Hosipital

    Taoyuan

Other trials in Taiwan

China4 sites

  • 307 Hospital of PLA

    Beijin, 100071

  • Nanjing Bayi Hospital

    Nanjing, 210002

  • Shanghai Cancer Hospital, Fudan University

    Shanghai, 200032

  • Zhongshan Hospital, Fudan University

    Shanghai, 200032

Other trials in China

About this study

Official title: An Open-Label, Single-Arm, Two-Stage, Multi-Centre Phase II Study to Evaluate the Efficacy and Safety of TLC388 as Second-line Treatment in Subjects With Advanced Hepatocellular Carcinoma

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.

Read the detailed description

A Phase II, open-label, single-arm, two-stage, multicenter study to evaluate the efficacy and safety of Lipotecan® monotherapy in patients with advanced hepatocellular carcinoma (HCC) and had failed sorafenib treatment due to sorafenib intolerance or radiographic progressive disease (PD).

Eligible patients received 40 mg/m2 of Lipotecan®, given as a 30-minute (+3 minutes) intravenous infusion, on Days 1, 8, and 15 of a 28-day cycle for maximum 6 cycles. Inter-cycle and intra-cycle dose delays were allowed within 21 days of the scheduled date to be reduced to 35 mg/m2 and further to 30 mg/m2 if a treatment-related adverse event (TRAE) met the criteria for dose reduction.

Tumor response was assessed every 2 cycles until Cycle 6, or at the early termination according to RECIST Version 1.1 judged by site investigator. The favorable response of CR, PR or SD would be confirmed within 28-35 days. Safety evaluations were conducted on a weekly basis from the day study treatment administered throughout each cycle.

Being tested
Lipotecan
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LipotecanDrug

    Also called Lipotecan, TLC388

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

Study groups in NCT02267213
Study groupRoleWhat they receive
LipotecanExperimentalAdminister 40mg of Lipotecan at D1, D8, D15 of each cycles.
Receives: Drug: Lipotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 8 weeks from initial treatment

Secondary outcomes (13)

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

    ORR (Objective response rate)

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

  2. Duration of Disease control (DDC)

    Duration of disease control is defined as the time from first documented evidence of CR or PR or SD until the first documentation of PD or death due to any cause, whichever occurs first.

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

  3. Time to Progression (TTP)

    Time to tumor progression is defined as the time from first study drug administration until the first documentation of tumor progression.

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

  4. Progression Free Survival (PFS)

    The PFS is defined as the time from the first dose to the date of progression or death, whichever occurs first, and subjects with no evidence of progression or death at the time of study completion (the analysis cut-off date) or who are receiving any further anticancer therapy will be censored on the date of the last adequate tumor assessment.

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

  5. Overall Survival (OS)

    The OS is defined as the time from the first dose to the date of death, regardless of the cause of death, and subjects who are alive at the time of study completion will be censored at the last known alive date. Subjects who commence treatment with another anticancer agent will be censored at the day before the other anticancer treatment starts.

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

  6. Change of Tumor markers/Bio-markers

    tumor markers/biomarkers, including α-fetoprotein (AFP), vascular endothelial growth factor (VEGF), transforming growth factor-β1 (TGF-β1), and interleukin-6 (IL-6)

    Measured: Baseline, the first dose (Cycle 1 Day 1), 2 months(C2D1), 3 months(C3D1), 4 months(C4D1), 5 months(C5D1), 6 months(C6D1) and/or Early termination (before 6 months)

  7. AEs

    Serious/ Adverse Events

    Measured: From ICF singed to 30 days after EOT

  8. Vital signs

    evaluate at every administration and the end of treatment

    Measured: Baseline, first treatment(C1D1), 1, 2, 4, 5, 6, 8, 9, 10, 12, 13, 14, 16, 17, 18, 20, 21, 22 weeks from the first treatment and/or Early termination (up to 24 weeks)

  9. Resting 12-lead ECGs

    12-Lead ECGs

    Measured: Baseline, the first dose (Cycle 1 Day 1), 2 months(C2D1), 3 months(C3D1), 4 months(C4D1), 5 months(C5D1), 6 months(C6D1) and/or Early termination (before 6 months)

  10. Hematology

    evaluate at every administration and the end of treatment

    Measured: Baseline, first treatment(C1D1), 1, 2, 4, 5, 6, 8, 9, 10, 12, 13, 14, 16, 17, 18, 20, 21, 22 weeks from the first treatment and/or Early termination (up to 24 weeks)

  11. Clinical chemistry

    evaluate at every administration and the end of treatment

    Measured: Baseline, first treatment(C1D1), 1, 2, 4, 5, 6, 8, 9, 10, 12, 13, 14, 16, 17, 18, 20, 21, 22 weeks from the first treatment and/or Early termination (up to 24 weeks)

  12. Urinalysis data

    Urinalysis Lab Values

    Measured: The first dose (Cycle 1 Day 1), 2 months(C2D1), 3 months(C3D1), 4 months(C4D1), 5 months(C5D1), 6 months(C6D1) and/or Early termination (before 6 months)

  13. PK parameters, including AUC, Cmax and Tmax of S,S-TLC388, S,R-TLC388, metabolites TLC-U1, TLC-U2, and topotecan

    PK parameters

    Measured: 0, 15, 29, 33, 40, 50 minutes, and 1, 1.5, 2, 4, 8 hour after the start of infusion of the 1st treatment and 1 week (2nd treatment); 0, 29 minutes and 4 hour after the start of infusion of the 3, 5, 6 and 7 weeks (the 3rd, 4th, 5th, 6th treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2014 (estimated)
  2. Study start10 Apr 2014
  3. Primary completion9 Jul 2015
  4. Study completion9 Jul 2015

Why it stopped: Current study design couldn't support futher development on this indication

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02267213
Sponsor's protocol ID
TLC388.4
Status last verified
Feb 2019
First submitted
11 Sep 2014
Last updated
26 Feb 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lipotecan in people with Hepatocellular Carcinoma, run by Taiwan Liposome Company at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Taiwan, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Current study design couldn't support futher development on this indication). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate (DCR) (time frame: 8 weeks from initial treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02267213.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.

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