HepatoCellular CarcinomaPhase 1/2NCT03035006
Lipotecan Based Concurrent Chemoradiotherapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
A Phase 1/2 study testing Lipotecan in people with HepatoCellular Carcinoma and Portal Vein Tumor Thrombosis, run by Taiwan Liposome Company at 4 sites in Taiwan.
Trial summary
This is a phase I/II dose-escalation study of lipotecan based concurrent chemoradiotherapy in hepatocellular carcinoma with portal vein tumor thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HepatoCellular Carcinoma, Portal Vein Tumor Thrombosis
- What is being tested?
- Lipotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 4 sitesTaiwan
- Study dates
- 14 Apr 2017to 31 Oct 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be males or females
- ≥20 years of age in Taiwan
- ≥18 years old in China
- Patients with histologically confirmed HCC or patients who do not have histological diagnosis, but the lesion is larger than 1 cm in a cirrhotic liver with typical HCC image of contrast enhanced CT scan or MRI. If the image characteristic is not typical of HCC, another contrast enhanced image modality should be confirmed for diagnosis.
- Patients with PVTT (BCLC stage C) who are not suitable for local therapies
- Patients with a measureable targeting lesion
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- Patients with an anticipated residual life expectancy ≥3 months
- Patients who have adequate organ function
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Patients who are willing to follow birth control requirements during the study treatment and continue until 2 months after the completion of study treatment
- Patients willing and able to comply with the study procedures and to sign a written ICF
Who cannot join
- Patients with infiltrative type HCC
- Patients with evidence of any extrahepatic metastasis, including but not limited to inferior vena cava thrombosis, bone metastasis, brain metastasis, or regional lymph node metastasis
- Patients with a history of West Haven criteria grade III-IV hepatic encephalopathy or ascites
- Patients with a history of other malignancy except primary HCC within 3 years prior to the screening visit, excluding skin squamous cell carcinoma or basal cell carcinoma
- Patients who fail to follow the radiation dose constraint in any critical organ in the radiotherapy planning
- Patients with an inadequately defined hepatic tumor margin for RT planning on MRI or CT that may impact treatment or safety based on investigator's judgment
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- Patients who have experienced significant allergy or hypersensitivity to the contrast medium for CT or MRI that makes it unsafe to perform the delineation for RT planning
- Patients with a history of liver transplantation
- Patients with a significant concurrent disease
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Taiwan University Hosipital
Taipei
Taipei Veteran General Hospital
Taipei
About this study
Official title: A Phase I/II, Dose-escalation Study of Lipotecan Based Concurrent Chemoradiotherapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
This is a phase I/II dose-escalation study of lipotecan based concurrent chemoradiotherapy in hepatocellular carcinoma with portal vein tumor thrombosis.
Read the detailed description
Protocol number: TLCTLC388A1008
Primary objective:
To evaluate the safety and tolerability, including maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), of Lipotecan based concurrent chemoradiotherapy (CCRT) in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT) unsuitable for local treatment.
Secondary Objective:
The secondary objective is to explore the efficacy of Lipotecan based CCRT in patients with HCC and PVTT and the effect on quality of life.
- Being tested
- Lipotecan
- Keywords
- Hepatocellular carcinoma, Portal vein tumor thrombosis, TLC388, Chemoradiotherapy, 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 TLC388
Lipotecan based concurrent chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Lipotecan based chemoradiotherapy | Experimental | Patients will receive Lipotecan based CCRT. Lipotecan will be given as a 30-minute (±3 minutes) iv infusion qw for 6 weeks at the predefined dose level for each cohort. A total of 6 doses of Lipotecan will be administered to each patient in conjunction with RT at 3.5 Gy per fraction for 16 fractions. During CCRT period, Lipotecan should be given within 2 hours prior to the start of RT, and the Lipotecan and RT should be delivered on the same day, unless any conditions fulfils with the dose interruption standards. Radiotherapy treatment, at the allocated dose level, is only permitted if the normal tissue dose constrain criteria are maintained Receives: Drug: Lipotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose determination for Lipotecan based CCRT
To determine maximum tolerated dose for Lipotecan based CCRT in HCC patients with portal vein tumor thrombosis
Measured: 3 months
Best objective response evaluation of portal vein tumor thrombosis
To evaluate the best objective response rate of portal vein tumor thrombosis
Measured: 1 year
Secondary outcomes (6)
Conversion rate (CR) of portal vein tumor thrombosis
To evaluate the conversion rate (CR rate) of PVTT
Measured: 1 year
Best overall response of overall disease
To evaluate the best overall response rate of overall disease
Measured: 1 year
Disease control rate of portal vein tumor thrombosis, liver tumors and overall disease
To evaluate DCR of PVTT, liver tumors (target lesions), and overall disease
Measured: 1 year
Time to progression of overall disease
To evaluate the TTP of overall disease after the start of concomitant Lipotecan based CCRT
Measured: 1 year
Progression free survival of overall disease
To evaluate the PFS of overall disease after the start of concomitant Lipotecan based CCRT
Measured: 1 year
Overall survival of overall disease
To evaluate the OS after the start of concomitant Lipotecan based CCRT
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start14 Apr 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Why it stopped: Current study design couldn't support futher development on this indication.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatoCellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Liposome Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl Brown, PhD, Study director, Taiwan Liposome Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035006
- Sponsor's protocol ID
- TLC388A1008
- Status last verified
- Nov 2018
- First submitted
- 25 Jan 2017
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Dose-escalation Study of Lipotecan Based Concurrent Chemoradiotherapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
- ClinicalTrials.gov ID
- NCT03035006
- Acronym / sponsor ID
- TLC388A1008
- Keywords
- Hepatocellular carcinoma, Portal vein tumor thrombosis, TLC388, Chemoradiotherapy, Lipotecan
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Current study design couldn't support futher development on this indication.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Taiwan Liposome CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I/II dose-escalation study of lipotecan based concurrent chemoradiotherapy in hepatocellular carcinoma with portal vein tumor thrombosis.
Detailed description
Protocol number: TLCTLC388A1008
Primary objective:
To evaluate the safety and tolerability, including maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), of Lipotecan based concurrent chemoradiotherapy (CCRT) in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT) unsuitable for local treatment.
Secondary Objective:
The secondary objective is to explore the efficacy of Lipotecan based CCRT in patients with HCC and PVTT and the effect on quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipotecan based chemoradiotherapy | Experimental | Drug: LipotecanPatients will receive Lipotecan based CCRT. Lipotecan will be given as a 30-minute (±3 minutes) iv infusion qw for 6 weeks at the predefined dose level for each cohort. A total of 6 doses of Lipotecan will be administered to each patient in conjunction with RT at 3.5 Gy per fraction for 16 fractions. During CCRT period, Lipotecan should be given within 2 hours prior to the start of RT, and the Lipotecan and RT should be delivered on the same day, unless any conditions fulfils with the dose interruption standards. Radiotherapy treatment, at the allocated dose level, is only permitted if the normal tissue dose constrain criteria are maintained |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients will be males or females
- Patients with histologically confirmed HCC or patients who do not have histological diagnosis, but the lesion is larger than 1 cm in a cirrhotic liver with typical HCC image of contrast enhanced CT scan or MRI. If the image characteristic is not typical of HCC, another contrast enhanced image modality should be confirmed for diagnosis.
- Patients with PVTT (BCLC stage C) who are not suitable for local therapies
- Patients with a measureable targeting lesion
- Patients with an anticipated residual life expectancy ≥3 months
Key exclusion criteria (9 listed)
- Patients with infiltrative type HCC
- Patients with evidence of any extrahepatic metastasis, including but not limited to inferior vena cava thrombosis, bone metastasis, brain metastasis, or regional lymph node metastasis
- Patients with a history of West Haven criteria grade III-IV hepatic encephalopathy or ascites
- Patients with a history of other malignancy except primary HCC within 3 years prior to the screening visit, excluding skin squamous cell carcinoma or basal cell carcinoma
- Patients who fail to follow the radiation dose constraint in any critical organ in the radiotherapy planning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipotecanAlso: TLC388Lipotecan based concurrent chemoradiotherapy | Drug | Lipotecan based chemoradiotherapy |
Primary outcome
Maximum tolerated dose determination for Lipotecan based CCRT
Time frame: 3 months
To determine maximum tolerated dose for Lipotecan based CCRT in HCC patients with portal vein tumor thrombosis
Best objective response evaluation of portal vein tumor thrombosis
Time frame: 1 year
To evaluate the best objective response rate of portal vein tumor thrombosis
6 secondary outcomes
Conversion rate (CR) of portal vein tumor thrombosis
Time frame: 1 year
Best overall response of overall disease
Time frame: 1 year
Disease control rate of portal vein tumor thrombosis, liver tumors and overall disease
Time frame: 1 year
Time to progression of overall disease
Time frame: 1 year
Progression free survival of overall disease
Time frame: 1 year
Overall survival of overall disease
Time frame: 1 year
Results and safety
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.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Brown, PhD study director
Taiwan Liposome Company
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lipotecan in people with HepatoCellular Carcinoma and Portal Vein Tumor Thrombosis, run by Taiwan Liposome Company at 4 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 11 inclusion and 9 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 (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?
Maximum tolerated dose determination for Lipotecan based CCRT (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2018.