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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01308645

Acronym

HCC

Enrollment

Registered

2011-03-04

Start date

2010-12-31

Completion date

2012-03-31

Last updated

2011-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

SBP Injection, HCC

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.

Interventions

DRUGSB injection

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Evaluating Tumor Response Rate	4 Months

Secondary

Measure	Time frame
Pain Scores on the Visual Analog Scale	4 Months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability scale	4 Months
Determine duration of response rate by measuring time to progression	4 Months

Countries

South Korea

Contacts

Primary ContactLee Jin woo, Prof.

jin@inha.ac.kr82-32-3598

Backup ContactLee Ji yeon, RN/BSc

twindleclara@inha.com82-32-890-1133

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026