Evaluation of Quality of Life and Survival With MS-20 in Patient With Advanced Hepatocellular Carcinoma (FDA IND 74572)

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase II Randomized, Controlled Study to Evaluate the Quality of Life, Survival and Therapeutic Benefits of MS-20 in Patient With Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00707681
• Other study ID #: MCRA06001A
• Status: Recruiting
• Phase: Phase 2
• First received: June 30, 2008
• Last updated: February 24, 2010
• Start date: March 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2010
• Source: Microbio Co Ltd
• Contact: David Yeh, MS
• Phone: 886226558558
• Email: davidyeh[@]microbio.com.tw
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients using European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

Subjects may be included in the study only if they meet all of the following criteria:

1. Subject aged ? 20;

2. Histologically documented, unresectable advanced HCC. For patients with difficulty in obtaining histological diagnosis, a "clinical diagnosis" of HCC is acceptable if all the following criteria are met:

• Chronic hepatitis B or C with evidence of liver cirrhosis;

• Presence of hepatic tumor(s) with image findings (sonography, CT scan) compatible with HCC and no evidence of gastrointestinal tumors;

• Elevated serum a-fetoprotein level ? 400 ng/ml;

3. Cancer of the Liver Italian Program (CLIP) score of 3-4;

4. Liver transaminase ? 5 times upper normal limits (UNL);

5. Patient fulfilling any of the follow conditions:

• Refuse to receive aggressive cancer therapy after explained to the subjects the benefits and risks;

• Progressive malignant disease after previous radiotherapy, percutaneous ethanol injection, radiofrequency ablation, transarterial embolization, transarterial chemoembolization, systemic chemotherapy, immunotherapy, or any experimental therapy, or unable to tolerate such therapy;

• No treatment of high priority is available;

6. ECOG performance status of 0 - 2;

7. Patients are willing and able to comply with study procedures and sign informed consent.

Exclusion Criteria

Subjects will be excluded from the study for any of the following reasons:

1. Patient with history of HCC rupture;

2. Medical condition requiring anticoagulant or anti-platelet drugs;

3. Patients with brain metastases;

4. Patient unable to receive oral medication;

5. Patients with significant renal function impairment (creatinine>1.5mg/dl), severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV) or physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that might render the subject at high risk from treatment;

6. Female subjects of childbearing potential who:

• are lactating; or

• have positive pregnancy test (urine) at V2;

7. Active infection or on antiretroviral therapy for HIV disease;

8. Patient with known hypersensitivity to any component of the study medication (soy bean or soy product).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• MS-20
4 ml/vial
• Placebo
4ml/vial

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	TaiChung

Sponsors (1)

Lead Sponsor	Collaborator
Microbio Co Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients		24 weeks	Yes
Secondary	Overall survival, Overall survival rate, Change from baseline of the highest weight observed, Change from baseline of body weight		24 weeks	Yes