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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

Phase 2
20 Years
80 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

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

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

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).

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Cheng-Yuan Peng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

China Medical University Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

December 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • microbio, MS-20, Hepatoma, Advanced Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular