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Evaluation of Quality of Life and Survival With MS-20 in Patient With Advanced Hepatocellular Carcinoma
This study is currently recruiting participants.
Verified by Microbio Co Ltd, June 2008
Sponsored by: Microbio Co Ltd
Information provided by: Microbio Co Ltd
ClinicalTrials.gov Identifier: NCT00707681
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: MS-20
Drug: Placebo
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Microbio Co Ltd:

Primary Outcome Measures:
  • To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival, Overall survival rate, Change from baseline of the highest weight observed, Change from baseline of body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Active Comparator
MS-20
Drug: MS-20
4 ml/vial
2: Placebo Comparator
Placebo
Drug: Placebo
4ml/vial

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707681

Contacts
Contact: David Yeh, MS 886226558558 ext 306 davidyeh@microbio.com.tw
Contact: Peter Pan, MS 886226558558 ext 311 peterpan@microbio.com.tw

Locations
Taiwan
China Medical University Hospital Recruiting
TaiChung, Taiwan, 40447
Contact: Cheng-Yuan Peng, MD     886422052121 ext 2264     cypeng@www.cmuh.org.tw    
Principal Investigator: Cheng-Yuan Peng, MD            
Sponsors and Collaborators
Microbio Co Ltd
Investigators
Principal Investigator: Cheng-Yuan Peng, MD China Medical University Hospital
  More Information

Responsible Party: MicroBio Co., Ltd. ( Mr. David Yeh, Director )
Study ID Numbers: MCRA06001A
Study First Received: June 30, 2008
Last Updated: July 2, 2008
ClinicalTrials.gov Identifier: NCT00707681  
Health Authority: United States: Food and Drug Administration

Keywords provided by Microbio Co Ltd:
microbio, MS-20, Hepatoma, Advanced Hepatocellular Carcinoma

Study placed in the following topic categories:
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Quality of Life
Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009