Carcinoma, HepatocellularPhase 2NCT00082082
A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma
A Phase 2 study testing Thymalfasin (thymosin alpha-1) and Trans arterial chemoembolization (TACE) in people with Carcinoma, Hepatocellular, run by SciClone Pharmaceuticals at 5 sites in United States.
Trial summary
The objective of this Phase II trial is to compare the efficacy and safety of 6 months of treatment with thymalfasin plus trans arterial chemoembolization (TACE) with TACE alone in adult patients with non-surgical hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Thymalfasin (thymosin alpha-1) and Trans arterial chemoembolization (TACE)
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Diagnosis of HCC by:
- Presence of HCC on biopsy (core biopsy), or, if biopsy is strongly contra-indicated due to safety or patient-related concerns, then the diagnosis of HCC can be determined by:
- A new hepatic defect on imaging with an AFP > 1000 ng/ml, or
- A new hepatic defect on ultrasound or CT with an AFP < 1000 ng/ml when one of the following is present:
- At least two additional imaging techniques show signs characteristic of HCC, or
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- The new hepatic defect has doubled in diameter over time, or
- The AFP has progressively risen to > 200 ng/ml and triples the mean baseline.
- HCC must be unresectable and non-transplantable.
- Hematocrit > 30%, platelet count >= 50,000 per microliter, WBC > 2.0 x 109/L, and polymorphonuclear white cell count >= 1.0 x 109/L.
- Adequate renal function as demonstrated by serum creatinine level < 1.5 mg/dl.
- If the patient is a woman, she is using a definitive method of birth control in consultation with her physician, or is surgically sterile or post-menopausal.
Who cannot join
- Concomitant chronic use of any drug known to be hepatotoxic, or of any immunosuppressive drug (Use of oral contraceptives will not exclude an otherwise eligible patient).
- Presence of main portal vein thrombosis or hepatic artery malformation.
- HCC amenable to treatment by surgical resection or hepatic transplantation.
- HIV infection diagnosed by HIV seropositivity and confirmed by Western blot.
- Concomitant or prior history of malignancy other than HCC within the last 10 years, except for curatively treated skin cancer or surgically cured in situ carcinoma of the cervix.
- Active infectious process that is not of a self-limiting nature. TB and AIDS are examples of infectious processes that are not of a self-limiting nature.
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- Pregnancy as documented by a urine pregnancy test. Women with reproductive potential must agree to practice an adequate method of birth control for the duration of the study.
- Alcohol or intravenous drug abuse within the previous 1 year.
- Previous treatment with thymalfasin.
- Patients with known hypersensitivity to iodine.
- Simultaneous participation in another investigational drug study, or participation in any clinical trial involving investigational drugs within 30 days of study entry.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Metropolitan Research
Fairfax, Virginia, 22031
University of Florida
Gainesville, Florida, 32610
Columbia University
New York, New York, 10032
William Beaumont Hospital
Royal Oak, Michigan, 48073
California Pacific Medical Center
San Francisco, California, 94115
About this study
Official title: A Trial of Thymalfasin With Trans Arterial Chemo-Embolization (TACE) in the Treatment of Adult Patients With Unresectable Hepatocellular Carcinoma: A Phase II Trial
The objective of this Phase II trial is to compare the efficacy and safety of 6 months of treatment with thymalfasin plus trans arterial chemoembolization (TACE) with TACE alone in adult patients with non-surgical hepatocellular carcinoma (HCC).
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Thymalfasin (thymosin alpha-1), Trans arterial chemoembolization (TACE)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymalfasin (thymosin alpha-1)Drug
Trans arterial chemoembolization (TACE)Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2004 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- SciClone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082082
- Sponsor's protocol ID
- Ta1-HCC-2K1001
- Status last verified
- Jan 2008
- First submitted
- 28 Apr 2004
- Last updated
- 15 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Thymalfasin With Trans Arterial Chemo-Embolization (TACE) in the Treatment of Adult Patients With Unresectable Hepatocellular Carcinoma: A Phase II Trial
- ClinicalTrials.gov ID
- NCT00082082
- Acronym / sponsor ID
- Ta1-HCC-2K1001
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SciClone PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 30 Apr 2004 (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.
The objective of this Phase II trial is to compare the efficacy and safety of 6 months of treatment with thymalfasin plus trans arterial chemoembolization (TACE) with TACE alone in adult patients with non-surgical hepatocellular carcinoma (HCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed written informed consent.
- Diagnosis of HCC by:
- HCC must be unresectable and non-transplantable.
- Hematocrit > 30%, platelet count >= 50,000 per microliter, WBC > 2.0 x 109/L, and polymorphonuclear white cell count >= 1.0 x 109/L.
- Adequate renal function as demonstrated by serum creatinine level < 1.5 mg/dl.
Key exclusion criteria (11 listed)
- Concomitant chronic use of any drug known to be hepatotoxic, or of any immunosuppressive drug (Use of oral contraceptives will not exclude an otherwise eligible patient).
- Presence of main portal vein thrombosis or hepatic artery malformation.
- HCC amenable to treatment by surgical resection or hepatic transplantation.
- HIV infection diagnosed by HIV seropositivity and confirmed by Western blot.
- Concomitant or prior history of malignancy other than HCC within the last 10 years, except for curatively treated skin cancer or surgically cured in situ carcinoma of the cervix.
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 |
|---|---|---|
| Thymalfasin (thymosin alpha-1) | Drug | – |
| Trans arterial chemoembolization (TACE) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 15 Jan 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thymalfasin (thymosin alpha-1) and Trans arterial chemoembolization (TACE) in people with Carcinoma, Hepatocellular, run by SciClone Pharmaceuticals at 5 sites in United States.
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 12 inclusion and 11 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 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 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.
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 15 Jan 2008.