Carcinoma, HepatocellularPhase 3NCT00225290
Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve
A Phase 3 study testing Thalidomide(Thado) in people with Carcinoma, Hepatocellular, run by TTY Biopharm at 1 site in Taiwan.
Trial summary
To compare the overall survival of thalidomide- and placebo-treated advanced HCC patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Thalidomide(Thado)
- How many people
- 230 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2003to not given
- Phase
- Phase 3
- 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
- Patients with measurable, metastatic or locally advanced hepatocellular carcinoma
- The diagnosis of HCC should be established either by cyto/histology
- Patients must be > 20 years of age.
- ECOG score < 2.
- Signed informed consent.
- Female patients at child-bearing age must have negative pregnancy test.
Who cannot join
- Patients with other systemic diseases which require concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
- Patients with advanced second primary malignancy are not eligible.
- Patients with active infection are not eligible.
- Patients with pregnancy or breast-feeding are not eligible.
- Patients with brain metastases are not eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Placebo-controlled, Randomized Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve
To compare the overall survival of thalidomide- and placebo-treated advanced HCC patients.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Thalidomide(Thado)
- Keywords
- Phase III, Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalidomide(Thado)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startFeb 2003
Why it stopped: slowly recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TTY Biopharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Li-Tzong Chen, M.D Ph.D., Principal investigator, Division of Cancer Research, National Health Research Institute Ward 191
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225290
- Sponsor's protocol ID
- T2202
- Status last verified
- Sep 2005
- First submitted
- 21 Sep 2005
- Last updated
- 12 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Randomized Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve
- ClinicalTrials.gov ID
- NCT00225290
- Acronym / sponsor ID
- T2202
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Phase III, Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slowly recruitment rate
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- TTY BiopharmIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- First posted
- 23 Sep 2005 (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.
To compare the overall survival of thalidomide- and placebo-treated advanced HCC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with measurable, metastatic or locally advanced hepatocellular carcinoma
- The diagnosis of HCC should be established either by cyto/histology
- Patients must be > 20 years of age.
- ECOG score < 2.
- Signed informed consent.
Key exclusion criteria (5 listed)
- Patients with other systemic diseases which require concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
- Patients with advanced second primary malignancy are not eligible.
- Patients with active infection are not eligible.
- Patients with pregnancy or breast-feeding are not eligible.
- Patients with brain metastases are not eligible.
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 |
|---|---|---|
| Thalidomide(Thado) | Drug | – |
Primary outcome
overall survival
Results and safety
The study was stopped early (reason given: slowly recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
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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.
Li-Tzong Chen, M.D Ph.D. principal investigator
Division of Cancer Research, National Health Research Institute Ward 191
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thalidomide(Thado) in people with Carcinoma, Hepatocellular, run by TTY Biopharm at 1 site 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 6 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: stopped early, as of the sponsor's last update on 12 Oct 2011. 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 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: slowly recruitment rate). 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?
overall survival. 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 12 Oct 2011.