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

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

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

All eligible patients will receive SB injection therapy for 6 cycles (14~21 days for each
cycle). Efficacy wll be evaluated every 3 cycles.

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
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

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Evaluating Tumor Response Rate

Outcome Time Frame:

4 Months

Safety Issue:


Principal Investigator

Lee Jin woo, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Inha University Hospital


Korea: Food and Drug Administration

Study ID:

SB Injection HCC



Start Date:

December 2010

Completion Date:

March 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • SBP Injection
  • HCC
  • Carcinoma
  • Carcinoma, Hepatocellular