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
Information provided by:
SBPharmaceutical IND, Co., LTD
First received: March 2, 2011
Last updated: June 8, 2011
Last verified: June 2011
The purpose of this study is to determine efficacy of SB injection in Hepatocellular Carcinoma (HCC).
Drug: SB injection
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||PhaseⅡ, Open Label, Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
Drug: SB injection
Infusion SB injection of 21.87 ml/m^2, IV route, 24 times for 4 months
All eligible patients will receive SB injection therapy for 6 cycles (14~21 days for each cycle). Efficacy wll be evaluated every 3 cycles.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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
|Inha University Hospital
|Incheon, Jung-gu, Korea, Republic of |
|Contact: Lee Jin woo, prof. 28-32-890-3598 firstname.lastname@example.org |
|Contact: Lee Ji yeon, RN/BSc 82-32-890-1133 email@example.com |
|Principal Investigator: Lee Jin woo, prof |
SBPharmaceutical IND, Co., LTD
||Lee Jin woo, Prof.
||Inha University Hospital
No publications provided
||Lee Dong-heum / executive director, SBPharmaceutical IND, Co., LTD
History of Changes
|Other Study ID Numbers:
||SB Injection HCC
|Study First Received:
||March 2, 2011
||June 8, 2011
||Korea: Food and Drug Administration
Keywords provided by SBPharmaceutical IND, Co., LTD:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial