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

Sponsor
Microbio Co Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00707681
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
33
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Study Start Date :
Mar 1, 2008
Anticipated Primary Completion Date :
Dec 1, 2010
Anticipated Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: I

MS-20

Drug: MS-20
4 ml/vial
Placebo Comparator: 2

Placebo

Drug: Placebo
4ml/vial

Outcome Measures

Primary Outcome Measures

  1. To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients [24 weeks]

Secondary Outcome Measures

  1. Overall survival, Overall survival rate, Change from baseline of the highest weight observed, Change from baseline of body weight [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

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

  2. Liver transaminase ≦ 5 times upper normal limits (UNL);

  3. 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;

  1. ECOG performance status of 0 - 2;

  2. 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

  1. 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;
  1. Female subjects of childbearing potential who:

  • are lactating; or

  • have positive pregnancy test (urine) at V2;

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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 China Medical University Hospital TaiChung Taiwan 40447

Sponsors and Collaborators

  • Microbio Co Ltd

Investigators

  • Principal Investigator: Cheng-Yuan Peng, MD, China Medical University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00707681
Other Study ID Numbers:
  • MCRA06001A
First Posted:
Jul 1, 2008
Last Update Posted:
Feb 26, 2010
Last Verified:
Feb 1, 2010
Keywords provided by , ,
microbio, MS-20, Hepatoma, Advanced Hepatocellular Carcinoma
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular

Study Results

No Results Posted as of Feb 26, 2010