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

NCT01308645 | Unknown Phase 2 DMC

• 1 other identifier: SB Injection HCC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Keywords

SBP Injection; HCC

Outcome Measures

Primary Outcomes (1)

• Evaluating Tumor Response Rate

  4 Months

Secondary Outcomes (3)

• 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

Interventions

SB injection DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SBPharmaceutical IND, Co., LTD: lead

Study Sites (1)

Inha University Hospital

Incheon, Jung-gu, South Korea

RECRUITING

Related Links

• Link Text : SBP

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Lee Jin woo, Prof.

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Jin woo, Prof.

CONTACT

82-32-3598; jin@inha.ac.kr

Lee Ji yeon, RN/BSc

CONTACT

82-32-890-1133; twindleclara@inha.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 4, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: June 10, 2011

Record last verified: 2011-06

Locations

KR (1)