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

Microbio

Status and phase: Unknown; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Placebo; Drug: MS-20

Study type: Interventional

Funder types: Industry

Identifiers

NCT00707681

MCRA06001A

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

I

Active Comparator group

Description:

MS-20

Treatment:

Drug: MS-20

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo