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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: MS-20; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • TaiChung, Taiwan, 40447
    • Recruiting
    • China Medical University Hospital
    • Contact: Cheng-Yuan Peng, MD; Phone Number: 2264 886422052121; Email: cypeng@www.cmuh.org.tw
    • Principal Investigator: Cheng-Yuan Peng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo; 4ml/vial
Active Comparator: I; MS-20	Drug: MS-20; 4 ml/vial

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival, Overall survival rate, Change from baseline of the highest weight observed, Change from baseline of body weight	24 weeks

Collaborators and Investigators

• Sponsor: Microbio Co Ltd
• Investigators: Principal Investigator: Cheng-Yuan Peng, MD, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: June 30, 2008
• First Submitted That Met QC Criteria: June 30, 2008
• First Posted (Estimate): July 1, 2008

Study Record Updates

• Last Update Posted (Estimate): February 26, 2010
• Last Update Submitted That Met QC Criteria: February 24, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: microbio, MS-20, Hepatoma, Advanced Hepatocellular Carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: MCRA06001A