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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by SBPharmaceutical IND, Co., LTD.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
SBPharmaceutical IND, Co., LTD
ClinicalTrials.gov Identifier:
NCT01308645
First received: March 2, 2011
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: SB injection
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SBPharmaceutical IND, Co., LTD:

Primary Outcome Measures:
  • Evaluating Tumor Response Rate [ Time Frame: 4 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Scores on the Visual Analog Scale [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability scale [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
  • Determine duration of response rate by measuring time to progression [ Time Frame: 4 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SB injection
    Infusion SB injection of 21.87 ml/m^2, IV route, 24 times for 4 months
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308645

Contacts
Contact: Lee Jin woo, Prof. 82-32-3598 jin@inha.ac.kr
Contact: Lee Ji yeon, RN/BSc 82-32-890-1133 twindleclara@inha.com

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

Additional Information:
No publications provided

Responsible Party: Lee Dong-heum / executive director, SBPharmaceutical IND, Co., LTD
ClinicalTrials.gov Identifier: NCT01308645     History of Changes
Other Study ID Numbers: SB Injection HCC
Study First Received: March 2, 2011
Last Updated: June 8, 2011
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014