Hepatocellular CarcinomaPhase 2HCCNCT01308645
Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma (HCC)
A Phase 2 study testing SB injection in people with Hepatocellular Carcinoma, run by SBPharmaceutical IND, Co., LTD at 1 site in South Korea.
Trial summary
The purpose of this study is to determine efficacy of SB injection in Hepatocellular Carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- SB injection
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Mar 2012
- 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
- Age of 18 years or over
- Patients with Hepatocellular carcinoma progression (HCC) and primary liver cancer as a diagnostic imaging test (eg, X-ray, CT, scan, ultrasound) can be measured in patients with a lesion
- Directly to standard therapy (surgery, RF ablation, TACE) is not possible, patients with advanced liver cancer. However, the standard treatment of the subject or subjects entirely voluntary participation of subjects participating at the discretion of the doctor or researcher can be deemed included in the selected target.
- Life expectancy ≥ 5 months
- ECOG status 0, 1, 2 patients
- Child-Pugh classification A, B patients
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- PLT 70,000, ANC 1,000 or more patients (OT / PT <upper normal limit x 5.0, Bilirubin <upper normal limit x 3.0)
- Female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7 days ago
- Patients or their legal representatives who have signed the informed consent form
Who cannot join
- Last 4 weeks the patients who had participated in another clinical trial
- Last 4 weeks the patients who received chemotherapy
- Associated with hepatocellular carcinoma in patients with a history of malignant tumor
- Hepatectomy or liver transplantation patients who received treatment.
- Active systemic infection requiring medical treatment
- Uncontrolled hypertension or diabetes mellitus.
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- Clinically Significant cardiac disease (myocardial infarction / angina / severe arrhythmia / congestive heart failure)
- Autoimmune diseases (systemic lupus erythematosus: SLE / rheumatoid arthritis / myasthenia gravis) and the patients currently being treated
- Presence or history of malignancy other than Hepatocellular carcinoma within 5 years
- Patients who have history of allergy with this investigational drug.
- Obvious cognitive or physical impairment that would prevent participation
- Pregnancy, lactation period and don't using contraception earnest Patients
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Inha University Hospital
Incheon, Jung-gu
Lee Jin woo, prof., 28-32-890-3598, jin@inha.com
Lee Ji yeon, RN/BSc, 82-32-890-1133, twinkleclara@inha.com
About this study
Official title: PhaseⅡ, Open Label, Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma
The purpose of this study is to determine efficacy of SB injection in Hepatocellular Carcinoma (HCC).
Read the detailed description
All eligible patients will receive SB injection therapy for 6 cycles (14~21 days for each cycle). Efficacy wll be evaluated every 3 cycles.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- SB injection
- Keywords
- SBP Injection, HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB injectionDrug
Infusion SB injection of 21.87 ml/m^2, IV route, 24 times for 4 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating Tumor Response Rate
Measured: 4 Months
Secondary outcomes (3)
Pain Scores on the Visual Analog Scale
Measured: 4 Months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability scale
Measured: 4 Months
Determine duration of response rate by measuring time to progression
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SBPharmaceutical IND, Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lee Jin woo, Prof., Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308645
- Sponsor's protocol ID
- SB Injection HCC
- Acronym
- HCC
- Status last verified
- Jun 2011
- First submitted
- 2 Mar 2011
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhaseⅡ, Open Label, Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01308645
- Acronym / sponsor ID
- HCC / SB Injection HCC
- Conditions
- Hepatocellular Carcinoma
- Keywords
- SBP Injection, HCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SBPharmaceutical IND, Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 4 Mar 2011 (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 purpose of this study is to determine efficacy of SB injection in Hepatocellular Carcinoma (HCC).
Detailed description
All eligible patients will receive SB injection therapy for 6 cycles (14~21 days for each cycle). Efficacy wll be evaluated every 3 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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 (9 listed)
- Age of 18 years or over
- Patients with Hepatocellular carcinoma progression (HCC) and primary liver cancer as a diagnostic imaging test (eg, X-ray, CT, scan, ultrasound) can be measured in patients with a lesion
- Directly to standard therapy (surgery, RF ablation, TACE) is not possible, patients with advanced liver cancer. However, the standard treatment of the subject or subjects entirely voluntary participation of subjects participating at the discretion of the doctor or researcher can be deemed included in the selected target.
- Life expectancy ≥ 5 months
- ECOG status 0, 1, 2 patients
Key exclusion criteria (12 listed)
- Last 4 weeks the patients who had participated in another clinical trial
- Last 4 weeks the patients who received chemotherapy
- Associated with hepatocellular carcinoma in patients with a history of malignant tumor
- Hepatectomy or liver transplantation patients who received treatment.
- Active systemic infection requiring medical treatment
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 |
|---|---|---|
| SB injectionInfusion SB injection of 21.87 ml/m^2, IV route, 24 times for 4 months | Drug | – |
Primary outcome
Evaluating Tumor Response Rate
Time frame: 4 Months
3 secondary outcomes
Pain Scores on the Visual Analog Scale
Time frame: 4 Months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability scale
Time frame: 4 Months
Determine duration of response rate by measuring time to progression
Time frame: 4 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
- Link Text : SBPLink provided by the sponsor.
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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.
Lee Jin woo, Prof. principal investigator
Inha University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB injection in people with Hepatocellular Carcinoma, run by SBPharmaceutical IND, Co., LTD at 1 site in South Korea.
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 12 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: status not confirmed, as of the sponsor's last update on 10 Jun 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lee Jin woo, Prof. (82-32-3598, jin@inha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating Tumor Response Rate (time frame: 4 Months). 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 10 Jun 2011.