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

June 8, 2011 updated by: SBPharmaceutical IND, Co., LTD

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jung-gu
      • Incheon, Jung-gu, Korea, Republic of
        • Recruiting
        • Inha University Hospital
        • Contact:
          • Lee Jin woo, prof.
          • Phone Number: 28-32-890-3598
          • Email: jin@inha.com
        • Contact:
        • Principal Investigator:
          • Lee Jin woo, prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluating Tumor Response Rate
Time Frame: 4 Months
4 Months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SBPharmaceutical IND, Co., LTD

Investigators

  • Principal Investigator: Lee Jin woo, Prof., Inha University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

March 2, 2011

First Submitted That Met QC Criteria

March 3, 2011

First Posted (Estimate)

March 4, 2011

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB Injection HCC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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