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Carcinoma, HepatocellularPhase 1/2NCT01425996

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

A Phase 1/2 study testing Lipotecan® (TLC388) in people with Carcinoma, Hepatocellular, run by Taiwan Liposome Company at 2 sites in Taiwan.

Terminated

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Lipotecan® (TLC388)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesTaiwan
Study dates
27 Oct 2011to 3 Oct 2014
Phase
Phase 1/2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Mackay Memorial Hospital

    Taipei

  • Taipei Veteran General Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: A Phase I/II, Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma

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.

Read the 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.

Being tested
Lipotecan® (TLC388)
Keywords
HCC, PVTT
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Lipotecan® (TLC388)Drug

    Also called 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
Study groups in NCT01425996
Study groupRoleWhat they receive
Lipotecan® (TLC388)ExperimentalDosage 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.
Receives: Drug: Lipotecan® (TLC388)

What is being measured

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

  1. Maximum tolerated dose (MTD)

    Maximum tolerated dose

    Measured: week 12

  2. PVTT response rate

    PVTT response rate

    Measured: week7

  3. Dose-limiting toxicity (DLT)

    Dose-limiting toxicity

    Measured: week 12

  4. Adverse Event/Serious Adverse Event

    Serious/ Adverse Event

    Measured: week 12

Secondary outcomes (6)

  1. Hepatic tumor response rate (overall tumor response rate)

    Hepatic tumor response rate (overall tumor response rate)

    Measured: week7, week12

  2. Tumor downstaging rate

    Tumor downstaging rate

    Measured: week7, week12

  3. Time to progression (TTP)

    Time to progression

    Measured: week7, week12, 1 year

  4. Progression-free survival (PFS)

    Progression-free survial

    Measured: week7, week12, 1 year

  5. Overall survival (OS)

    Overall survival

    Measured: week7, week12, 1year

  6. Change from baseline in tumor marker/biomarkers

    Change from baseline in tumor marker/biomarkers

    Measured: week4, week7, week12

Timeline

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

  1. First posted30 Aug 2011 (estimated)
  2. Study start27 Oct 2011
  3. Primary completion3 Oct 2014
  4. Study completion3 Oct 2014

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 1/2
Primary purpose
Treatment
Intervention model
Sequential
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01425996
Sponsor's protocol ID
TLC388.2
Status last verified
Aug 2018
First submitted
15 Aug 2011
Last updated
21 Aug 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lipotecan® (TLC388) in people with Carcinoma, Hepatocellular, run by Taiwan Liposome Company at 2 sites in Taiwan.

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 4 inclusion and 6 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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. 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?

Maximum tolerated dose (MTD) (time frame: week 12). The study lists 4 primary outcomes in all. 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 NCT01425996.

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 21 Aug 2018.

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