Hepatocellular CarcinomaPhase 2NCT00707681
Evaluation of Quality of Life and Survival With MS-20 in Patient With Advanced Hepatocellular Carcinoma (FDA IND 74572)
A Phase 2 study testing MS-20 in people with Hepatocellular Carcinoma, run by Microbio Co Ltd at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- MS-20
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2008to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 40447
Cheng-Yuan Peng, MD, 886422052121 ext. 2264, cypeng@www.cmuh.org.tw
Cheng-Yuan Peng, MD
About this 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
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
- Being tested
- MS-20, Placebo
- Keywords
- microbio, MS-20, Hepatoma, Advanced Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS-20Drug
4 ml/vial
PlaceboDrug
4ml/vial
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | MS-20 Receives: Drug: MS-20 |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients
Measured: 24 weeks
Secondary outcomes (1)
Overall survival, Overall survival rate, Change from baseline of the highest weight observed, Change from baseline of body weight
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microbio Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Cheng-Yuan Peng, MD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707681
- Sponsor's protocol ID
- MCRA06001A
- Status last verified
- Feb 2010
- First submitted
- 30 Jun 2008
- Last updated
- 26 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00707681
- Acronym / sponsor ID
- MCRA06001A
- Conditions
- Hepatocellular Carcinoma
- Keywords
- microbio, MS-20, Hepatoma, Advanced Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Microbio Co LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 1 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: MS-20MS-20 |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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:
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MS-204 ml/vial | Drug | I |
| Placebo4ml/vial | Drug | 2 |
Primary outcome
To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients
Time frame: 24 weeks
1 secondary outcome
Overall survival, Overall survival rate, Change from baseline of the highest weight observed, Change from baseline of body weight
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-Yuan Peng, MD principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MS-20 in people with Hepatocellular Carcinoma, run by Microbio Co Ltd at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Yeh, MS (886226558558 ext. 306, davidyeh@microbio.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2010.