Overview

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

Status:
Unknown status

Trial end date:
2012-03-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

SBPharmaceutical IND, Co., LTD

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
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