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

Hepatocellular Carcinoma Clinical Trial

— HCC  

Official title:

PhaseⅡ, Open Label, Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01308645
• Other study ID #: SB Injection HCC
• Status: Recruiting
• Phase: Phase 2
• First received: March 2, 2011
• Last updated: June 8, 2011
• Start date: December 2010
• Est. completion date: March 2012

Study information

• Verified date: June 2011
• Source: SBPharmaceutical IND, Co., LTD
• Contact: Lee Jin woo, Prof.
• Phone: 82-32-3598
• Email: jin[@]inha.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon	Jung-gu

Sponsors (1)

Lead Sponsor	Collaborator
SBPharmaceutical IND, Co., LTD

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating Tumor Response Rate		4 Months	No
Secondary	Pain Scores on the Visual Analog Scale		4 Months	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability scale		4 Months	No
Secondary	Determine duration of response rate by measuring time to progression		4 Months	No

External Links

•   Link Text : SBP