Clinical trial NCT01308645: Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma (HCC)
Official title: PhaseⅡ, Open Label, Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: SBP Injection
HCC
Lead sponsor: SBPharmaceutical IND, Co., LTD
Sponsor class: INDUSTRY
First posted: 2011-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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 \<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

Primary outcomes:
measure: Evaluating Tumor Response Rate
timeFrame: 4 Months
Secondary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: 4 Months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability scale
timeFrame: 4 Months
measure: Determine duration of response rate by measuring time to progression
timeFrame: 4 Months
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Jung-gu
Study officials:
affiliation: Inha University Hospital
name: Lee Jin woo, Prof.
role: PRINCIPAL_INVESTIGATOR
References: