Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma (HCC)
This study is currently recruiting participants.
Verified June 2011 by SBPharmaceutical IND, Co., LTD
Sponsor:
SBPharmaceutical IND, Co., LTD
Information provided by:
SBPharmaceutical IND, Co., LTD
ClinicalTrials.gov Identifier:
NCT01308645
First received: March 2, 2011
Last updated: June 8, 2011
Last verified: June 2011
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Purpose
The purpose of this study is to determine efficacy of SB injection in Hepatocellular Carcinoma (HCC).
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Drug: SB injection |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PhaseⅡ, Open Label, Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma |
Further study details as provided by SBPharmaceutical IND, Co., LTD:
Primary Outcome Measures:
- Evaluating Tumor Response Rate [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pain Scores on the Visual Analog Scale [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability scale [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
- Determine duration of response rate by measuring time to progression [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: SB injection
Infusion SB injection of 21.87 ml/m^2, IV route, 24 times for 4 months
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308645
Contacts
| Contact: Lee Jin woo, Prof. | 82-32-3598 | jin@inha.ac.kr |
| Contact: Lee Ji yeon, RN/BSc | 82-32-890-1133 | twindleclara@inha.com |
Locations
| Korea, Republic of | |
| Inha University Hospital | Recruiting |
| Incheon, Jung-gu, Korea, Republic of | |
| Contact: Lee Jin woo, prof. 28-32-890-3598 jin@inha.com | |
| Contact: Lee Ji yeon, RN/BSc 82-32-890-1133 twinkleclara@inha.com | |
| Principal Investigator: Lee Jin woo, prof | |
Sponsors and Collaborators
SBPharmaceutical IND, Co., LTD
Investigators
| Principal Investigator: | Lee Jin woo, Prof. | Inha University Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Lee Dong-heum / executive director, SBPharmaceutical IND, Co., LTD |
| ClinicalTrials.gov Identifier: | NCT01308645 History of Changes |
| Other Study ID Numbers: | SB Injection HCC |
| Study First Received: | March 2, 2011 |
| Last Updated: | June 8, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by SBPharmaceutical IND, Co., LTD:
|
SBP Injection HCC |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 16, 2013