Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma (HCC) (HCC)
June 8, 2011 updated by: SBPharmaceutical IND, Co., LTD
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).
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jung-gu
-
Incheon, Jung-gu, Korea, Republic of
- Recruiting
- Inha University Hospital
-
Contact:
- Lee Jin woo, prof.
- Phone Number: 28-32-890-3598
- Email: jin@inha.com
-
Contact:
- Lee Ji yeon, RN/BSc
- Phone Number: 82-32-890-1133
- Email: twinkleclara@inha.com
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Principal Investigator:
- Lee Jin woo, prof
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluating Tumor Response Rate
Time Frame: 4 Months
|
4 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain Scores on the Visual Analog Scale
Time Frame: 4 Months
|
4 Months
|
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability scale
Time Frame: 4 Months
|
4 Months
|
|
Determine duration of response rate by measuring time to progression
Time Frame: 4 Months
|
4 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lee Jin woo, Prof., Inha University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
March 1, 2012
Study Registration Dates
First Submitted
March 2, 2011
First Submitted That Met QC Criteria
March 3, 2011
First Posted (Estimate)
March 4, 2011
Study Record Updates
Last Update Posted (Estimate)
June 10, 2011
Last Update Submitted That Met QC Criteria
June 8, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SB Injection HCC
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