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

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SB injection
Sponsored by
SBPharmaceutical IND, Co., LTD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring SBP Injection, HCC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Inha University HospitalRecruiting

Outcomes

Primary Outcome Measures

Evaluating Tumor Response Rate

Secondary Outcome Measures

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

Full Information

First Posted
March 2, 2011
Last Updated
June 8, 2011
Sponsor
SBPharmaceutical IND, Co., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT01308645
Brief Title
Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma (HCC)
Acronym
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

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
SBPharmaceutical IND, Co., LTD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
SBP Injection, HCC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SB injection
Intervention Description
Infusion SB injection of 21.87 ml/m^2, IV route, 24 times for 4 months
Primary Outcome Measure Information:
Title
Evaluating Tumor Response Rate
Time Frame
4 Months
Secondary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Time Frame
4 Months
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability scale
Time Frame
4 Months
Title
Determine duration of response rate by measuring time to progression
Time Frame
4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Jin woo, Prof.
Phone
82-32-3598
Email
jin@inha.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Ji yeon, RN/BSc
Phone
82-32-890-1133
Email
twindleclara@inha.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Jin woo, Prof.
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inha University Hospital
City
Incheon
State/Province
Jung-gu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jin woo, prof.
Phone
28-32-890-3598
Email
jin@inha.com
First Name & Middle Initial & Last Name & Degree
Lee Ji yeon, RN/BSc
Phone
82-32-890-1133
Email
twinkleclara@inha.com
First Name & Middle Initial & Last Name & Degree
Lee Jin woo, prof

12. IPD Sharing Statement

Links:
URL
http://www.sbp.com
Description
Link Text : SBP

Learn more about this trial

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

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