Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma (HCC) (HCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01308645
Recruitment Status : Unknown
Verified June 2011 by SBPharmaceutical IND, Co., LTD.
Recruitment status was:  Recruiting
First Posted : March 4, 2011
Last Update Posted : June 10, 2011
Information provided by:
SBPharmaceutical IND, Co., LTD

Brief Summary:
The purpose of this study is to determine efficacy of SB injection in Hepatocellular Carcinoma (HCC).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: SB injection Phase 2

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PhaseⅡ, Open Label, Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma
Study Start Date : December 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : March 2012

Intervention Details:
  • Drug: SB injection
    Infusion SB injection of 21.87 ml/m^2, IV route, 24 times for 4 months

Primary Outcome Measures :
  1. Evaluating Tumor Response Rate [ Time Frame: 4 Months ]

Secondary Outcome Measures :
  1. Pain Scores on the Visual Analog Scale [ Time Frame: 4 Months ]
  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability scale [ Time Frame: 4 Months ]
  3. Determine duration of response rate by measuring time to progression [ Time Frame: 4 Months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age of 18 years or over
  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:

  1. Last 4 weeks the patients who had participated in another clinical trial
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01308645

Contact: Lee Jin woo, Prof. 82-32-3598
Contact: Lee Ji yeon, RN/BSc 82-32-890-1133

Korea, Republic of
Inha University Hospital Recruiting
Incheon, Jung-gu, Korea, Republic of
Contact: Lee Jin woo, prof.    28-32-890-3598   
Contact: Lee Ji yeon, RN/BSc    82-32-890-1133   
Principal Investigator: Lee Jin woo, prof         
Sponsors and Collaborators
SBPharmaceutical IND, Co., LTD
Principal Investigator: Lee Jin woo, Prof. Inha University Hospital

Additional Information:
Responsible Party: Lee Dong-heum / executive director, SBPharmaceutical IND, Co., LTD Identifier: NCT01308645     History of Changes
Other Study ID Numbers: SB Injection HCC
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by SBPharmaceutical IND, Co., LTD:
SBP Injection

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases