Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma (HCC)
NCT ID: NCT01308645
Last Updated: 2011-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2010-12-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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SB injection
Infusion SB injection of 21.87 ml/m\^2, IV route, 24 times for 4 months
Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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.
4. Life expectancy ≥ 5 months
5. ECOG status 0, 1, 2 patients
6. Child-Pugh classification A, B patients
7. PLT 70,000, ANC 1,000 or more patients (OT / PT \<upper normal limit x 5.0, Bilirubin \<upper normal limit x 3.0)
8. 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
9. Patients or their legal representatives who have signed the informed consent form
Exclusion Criteria
2. Last 4 weeks the patients who received chemotherapy
3. Associated with hepatocellular carcinoma in patients with a history of malignant tumor
4. Hepatectomy or liver transplantation patients who received treatment.
5. Active systemic infection requiring medical treatment
6. Uncontrolled hypertension or diabetes mellitus.
7. Clinically Significant cardiac disease (myocardial infarction / angina / severe arrhythmia / congestive heart failure)
8. Autoimmune diseases (systemic lupus erythematosus: SLE / rheumatoid arthritis / myasthenia gravis) and the patients currently being treated
9. Presence or history of malignancy other than Hepatocellular carcinoma within 5 years
10. Patients who have history of allergy with this investigational drug.
11. Obvious cognitive or physical impairment that would prevent participation
12. Pregnancy, lactation period and don't using contraception earnest Patients
18 Years
ALL
No
Sponsors
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SBPharmaceutical IND, Co., LTD
INDUSTRY
Responsible Party
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SBPharmaceutical IND, Co., LTD
Principal Investigators
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Lee Jin woo, Prof.
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Locations
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Inha University Hospital
Incheon, Jung-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Link Text : SBP
Other Identifiers
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SB Injection HCC
Identifier Type: -
Identifier Source: org_study_id
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