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

Phase 2

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Placebo; Drug: MS-20

• Registration Number: NCT00707681
• Lead Sponsor: Microbio Co Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-06-30
• Study First Submitted QC: 2008-06-30
• Study First Posted: 2008-07-01
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-24
• Last Update Posted: 2010-02-26
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 α-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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
I	MS-20	MS-20

Primary Outcome Measures

Name	Time	Method
To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients	24 weeks

Secondary Outcome Measures

Name	Time	Method
Overall survival, Overall survival rate, Change from baseline of the highest weight observed, Change from baseline of body weight	24 weeks

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 TaiChung, Taiwan