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

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

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

Official Title
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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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: SB injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 years or over 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 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. Life expectancy ≥ 5 months ECOG status 0, 1, 2 patients Child-Pugh classification A, B patients PLT 70,000, ANC 1,000 or more patients (OT / PT <upper normal limit x 5.0, Bilirubin <upper normal limit x 3.0) 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 Patients or their legal representatives who have signed the informed consent form Exclusion Criteria: Last 4 weeks the patients who had participated in another clinical trial Last 4 weeks the patients who received chemotherapy Associated with hepatocellular carcinoma in patients with a history of malignant tumor Hepatectomy or liver transplantation patients who received treatment. Active systemic infection requiring medical treatment Uncontrolled hypertension or diabetes mellitus. Clinically Significant cardiac disease (myocardial infarction / angina / severe arrhythmia / congestive heart failure) Autoimmune diseases (systemic lupus erythematosus: SLE / rheumatoid arthritis / myasthenia gravis) and the patients currently being treated Presence or history of malignancy other than Hepatocellular carcinoma within 5 years Patients who have history of allergy with this investigational drug. Obvious cognitive or physical impairment that would prevent participation Pregnancy, lactation period and don't using contraception earnest Patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SB injection|Infusion SB injection of 21.87 ml/m^2, IV route, 24 times for 4 months|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating Tumor Response Rate |  | 4 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC, SBP Injection