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

NCT00707681 | Unknown Phase 2 DMC

• 1 other identifier: MCRA06001A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

microbio, MS-20, Hepatoma, Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (1)

• Overall survival, Overall survival rate, Change from baseline of the highest weight observed, Change from baseline of body weight

  24 weeks

Study Arms (2)

I

ACTIVE COMPARATOR

MS-20

Drug: MS-20

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

MS-20 DRUG

4 ml/vial

I

Placebo DRUG

4ml/vial

2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects may be included in the study only if they meet all of the following criteria:
• Subject aged ≧ 20;
• 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;
• Cancer of the Liver Italian Program (CLIP) score of 3-4;
• Liver transaminase ≦ 5 times upper normal limits (UNL);
• 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;
• ECOG performance status of 0 - 2;
• Patients are willing and able to comply with study procedures and sign informed consent.

You may not qualify if:

• Subjects will be excluded from the study for any of the following reasons:
• Patient with history of HCC rupture;
• Medical condition requiring anticoagulant or anti-platelet drugs;
• Patients with brain metastases;
• Patient unable to receive oral medication;
• 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;
• Female subjects of childbearing potential who:
• are lactating; or
• have positive pregnancy test (urine) at V2;
• Active infection or on antiretroviral therapy for HIV disease;
• Patient with known hypersensitivity to any component of the study medication (soy bean or soy product).

Sponsors & Collaborators

• Microbio Co Ltd: lead

Study Sites (1)

China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Cheng-Yuan Peng, MD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Yeh, MS

CONTACT

886226558558; davidyeh@microbio.com.tw

Cynthia Lo, MS

CONTACT

886226558558; cynthia.lo@microbio.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 1, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 26, 2010

Record last verified: 2010-02

Locations

TW (1)