Inoperable HCCPhase 1/2NCT01251458
Hepatocellular Carcinoma (HCC)_Torisel_
A Phase 1/2 study testing Torisel in people with Inoperable HCC, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inoperable HCC
- What is being tested?
- Torisel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteHong Kong
- Study dates
- Oct 2009to Jan 2016
- 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
- Histologically confirmed hepatocellular carcinoma that is not amenable to curative resection
- measurable disease
- Age >=18 years.
- Life expectancy of greater than 12 weeks.
- ECOG performance status <= 2
- Prior systemic therapy for HCC is allowed
Show all 9Show fewer
- Adequate haematologic, renal and hepatic function
- Absence of cirrhosis or Child's A cirrhosis
- Fasting total cholesterol <9.1 mmol/liter and fasting triglyceride level <4.5 mmol/liter)
Who cannot join
- Patients who have had systemic therapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
- Patients receiving any other investigational agents concurrently.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Uncontrolled intercurrent diseases such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
Official title: Phase I/II Study of Temsirolimus (Torisel®) as Novel Therapeutic Drug for Patients With Unresectable Hepatocellular Carcinoma (HCC)- A Correlative Study With Stathmin Over-expression
This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel
- Conditions
- Inoperable HCC
- Being tested
- Torisel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToriselDrug
Torisel will be administered intravenously as an IV infusion over a 30-minute period in adult clinical studies.
| Study group | Role | What they receive |
|---|---|---|
| Torisel | Experimental | Not described Receives: Drug: Torisel |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To establish the maximum tolerated dose (MTD) and a suitable dose for Phase II evaluation of Torisel® given as a weekly dose in patients with advanced hepatocellular carcinoma (HCC)
Measured: 2 years
Secondary outcomes (7)
• To determine and establish the safety and toxicity profile of Torisel® and to identify any dose limiting toxicities (DLTs) in advanced HCC
Measured: 2 Years
• To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel®
Measured: 4 Years
• To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel®
Measured: 2 years
• To determine the response rate (CR and PR) based on RECIST criteria
Measured: 2 years
• To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD ≥ 12 weeks)
Measured: 2 years
• To determine duration of response (DR)
Measured: 2 years
• To determine overall survival (OS)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startOct 2009
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inoperable HCCStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Winnie Yeo, MD, FRCP, Principal investigator, Department of Clinical Oncology, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251458
- Sponsor's protocol ID
- HCC022
- Status last verified
- Jan 2016
- First submitted
- 1 Dec 2010
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Temsirolimus (Torisel®) as Novel Therapeutic Drug for Patients With Unresectable Hepatocellular Carcinoma (HCC)- A Correlative Study With Stathmin Over-expression
- ClinicalTrials.gov ID
- NCT01251458
- Acronym / sponsor ID
- HCC022
- Conditions
- Inoperable HCC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Dec 2010 (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 study to evaluate dose limited toxicity and efficacy of Torisel
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Torisel | Experimental | Drug: Torisel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed hepatocellular carcinoma that is not amenable to curative resection
- measurable disease
- Age >=18 years.
- Life expectancy of greater than 12 weeks.
- ECOG performance status <= 2
Key exclusion criteria (5 listed)
- Patients who have had systemic therapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
- Patients receiving any other investigational agents concurrently.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Uncontrolled intercurrent diseases such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women.
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 |
|---|---|---|
| ToriselTorisel will be administered intravenously as an IV infusion over a 30-minute period in adult clinical studies. | Drug | Torisel |
Primary outcome
• To establish the maximum tolerated dose (MTD) and a suitable dose for Phase II evaluation of Torisel® given as a weekly dose in patients with advanced hepatocellular carcinoma (HCC)
Time frame: 2 years
7 secondary outcomes
• To determine and establish the safety and toxicity profile of Torisel® and to identify any dose limiting toxicities (DLTs) in advanced HCC
Time frame: 2 Years
• To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel®
Time frame: 4 Years
• To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel®
Time frame: 2 years
• To determine the response rate (CR and PR) based on RECIST criteria
Time frame: 2 years
• To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD ≥ 12 weeks)
Time frame: 2 years
• To determine duration of response (DR)
Time frame: 2 years
• To determine overall survival (OS)
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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.
Winnie Yeo, MD, FRCP principal investigator
Department of Clinical Oncology, The Chinese University of Hong Kong
1 site 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 Torisel in people with Inoperable HCC, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 9 inclusion and 5 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: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
• To establish the maximum tolerated dose (MTD) and a suitable dose for Phase II evaluation of Torisel® given as a weekly dose in patients with advanced hepatocellular carcinoma (HCC) (time frame: 2 years). 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 28 Sep 2016; AzTrials last refreshed its copy on 31 Oct 2026.