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

SB Pharma

Status and phase: Unknown; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: SB injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01308645

SB Injection HCC

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)