CarcinomaPhase 2NCT01097083
Coriolus Versicolor as Palliative Therapy Compared to Placebo in Patients With Child-Pugh C Unresectable Hepatocellular Carcinoma
A Phase 2 study testing Coriolus Versicolor in people with Carcinoma and Therapy, run by National University Hospital, Singapore at 3 sites in Singapore.
Trial summary
The hypothesis of this study is that the median time to progression in the experimental arm is 2 months as compared to the placebo arm of 1.4 months Read more about this study
- Who is it for?
- Ages 21 years and older
- What is being tested?
- Coriolus Versicolor
- How many people
- 20 participants
- Where
- 3 sitesSingapore
- Study dates
- Apr 2010to Oct 2013
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of HCC is made either by histological examination of tumor tissue or imaging evidence of a typical space-occupying lesion in the liver together with a serum AFP concentration of above 500 ng/ml (normal value, 10 ng/ml) in a known carrier of hepatitis B or C, or AFP above 400 ng/ml in non Hepatitis B or C carrier.
- Patients with unresectable HCC that is not amenable to liver transplantation nor local ablative technique and who are not suitable for any conventional systemic therapy (including sorafenib and chemotherapy).
- Patients with Child-Pugh Class C liver cirrhosis (Child-Pugh Scores of 10-15 points). Patients with Child-Pugh Class A or B liver cirrhosis who are not eligible for conventional therapy or other clinical trials or who refuse conventional therapy are included
- Life Expectancy of at least 12 weeks
- All patients should have anti-HBc antibodies tested if HBs Ag is negative. If anti-HBc is positive, HBV DNA detection should be performed to determine viral load. An undetectable Hep B DNA level (DNA levels < 12 IU/ml) in the presence of a positive Hep B core total antibody would indicate no active hepatitis infection and the subject would still be eligible for this trial.
- Age >21 years.
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- Performance status ECOG 0 - 2
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count > 1.5 x 109/L Platelets > 50 x 109/L Haemoglobin > 9.0g/dl Total bilirubin < 51umol/L (3 mg /dL) AST (SGOT)/ALT (SGPT) < 5 X institutional ULN Creatinine < 1.5 ULN INR <1.7 or prothrombin time (PT) <4 seconds above ULN
- Patients who have not received any local or systemic treatment in the last 4 weeks.
- Measurable disease according to RECIST
- Ability to understand and the willingness to sign a written informed consent document.
- Ability to swallow oral medication
- The effects of C versicolor on the developing human fetus are unknown. For this reason, woman of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Who cannot join
- Patients with a history of prior malignancy that is distinct in site and histology from HCC except non-melanoma skin cancer. Any cancer curatively treated more than 3 years prior to entry is permitted.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, intractable ascites that could not be controlled by medical therapy
- Prior use of C versicolor or Yunzhi for HCC
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients who are using other chinese herbal therapies concurrently or on any other investigation agents for treatment of their cancer
- Known of history of allergic reactions attributed to compounds of similar chemical or biologic composition used in the study.
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- Presence of active hepatitis B/C flare.
- Known history of Human Immunodeficiency Virus (HIV) Infection
- Gastrointestinal disease which could affect the absorption or pharmacokinetics of the study drug as determined by investigator
- Psychiatric illness/social situations that would limit compliance with study requirements. Patients with severe depression or psychiatric disorders will be excluded.
- Known alcohol and/or substance abuser that may interfere with the subject's participation in the study or evaluation of study results.
- Pregnancy or breast-feeding subjects. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 14 days prior to study enrollment and must be willing to use adequate contraception
- Patients suffering from autoimmune disease, patients on concomitant long-term immunosuppressant therapy and those scheduled to receive bone marrow transplants
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites
National University Hospital
Singapore, Singapore, 119074
Singapore General Hospital
Singapore, 169608
National Cancer Centre
Singapore, 169610
About this study
Official title: A Randomized Phase II Trial of Coriolus Versicolor as Palliative Therapy Compared to Placebo in Patients With Child-Pugh C Unresectable Hepatocellular Carcinoma or Who Are Unfit for Standard Therapy
The hypothesis of this study is that the median time to progression in the experimental arm is 2 months as compared to the placebo arm of 1.4 months
- Being tested
- Coriolus Versicolor
- Keywords
- Patients With Child-Pugh C Unresectable Hepatocellular Carcinoma, Patients who are unfit for standard therapy
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coriolus VersicolorDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Wei Peng Yong, MRCP, MB ChB', Principal investigator, National University Hospital, SingaporeChoo Su Pin, BMBS, MRCP, M Med, Principal investigator, National Cancer CentreTan Chee Kiat, MBBS, FRCP, FAMS, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097083
- Sponsor's protocol ID
- 3
- Status last verified
- Jan 2014
- First submitted
- 30 Mar 2010
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Okuda K, Ohtsuki T, Obata H, Tomimatsu M, Okazaki N, Hasegawa H, Nakajima Y, Ohnishi K. Natural history of hepatocellular carcinoma and prognosis in relation to treatment. Study of 850 patients. Cancer. 1985 Aug 15;56(4):918-28. doi: 10.1002/1097-0142(19850815)56:43.0.co;2-e.
PubMed 2990661Falkson G, Ryan LM, Johnson LA, Simson IW, Coetzer BJ, Carbone PP, Creech RH, Schutt AJ. A random phase II study of mitoxantrone and cisplatin in patients with hepatocellular carcinoma. An ECOG study. Cancer. 1987 Nov 1;60(9):2141-5. doi: 10.1002/1097-0142(19871101)60:93.0.co;2-4.
PubMed 2830952
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Coriolus Versicolor as Palliative Therapy Compared to Placebo in Patients With Child-Pugh C Unresectable Hepatocellular Carcinoma or Who Are Unfit for Standard Therapy
- ClinicalTrials.gov ID
- NCT01097083
- Acronym / sponsor ID
- 3
- Keywords
- Patients With Child-Pugh C Unresectable Hepatocellular Carcinoma, Patients who are unfit for standard therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 1 Apr 2010 (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.
The hypothesis of this study is that the median time to progression in the experimental arm is 2 months as compared to the placebo arm of 1.4 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The diagnosis of HCC is made either by histological examination of tumor tissue or imaging evidence of a typical space-occupying lesion in the liver together with a serum AFP concentration of above 500 ng/ml (normal value, 10 ng/ml) in a known carrier of hepatitis B or C, or AFP above 400 ng/ml in non Hepatitis B or C carrier.
- Patients with unresectable HCC that is not amenable to liver transplantation nor local ablative technique and who are not suitable for any conventional systemic therapy (including sorafenib and chemotherapy).
- Patients with Child-Pugh Class C liver cirrhosis (Child-Pugh Scores of 10-15 points). Patients with Child-Pugh Class A or B liver cirrhosis who are not eligible for conventional therapy or other clinical trials or who refuse conventional therapy are included
- Life Expectancy of at least 12 weeks
- All patients should have anti-HBc antibodies tested if HBs Ag is negative. If anti-HBc is positive, HBV DNA detection should be performed to determine viral load. An undetectable Hep B DNA level (DNA levels < 12 IU/ml) in the presence of a positive Hep B core total antibody would indicate no active hepatitis infection and the subject would still be eligible for this trial.
Key exclusion criteria (13 listed)
- Patients with a history of prior malignancy that is distinct in site and histology from HCC except non-melanoma skin cancer. Any cancer curatively treated more than 3 years prior to entry is permitted.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, intractable ascites that could not be controlled by medical therapy
- Prior use of C versicolor or Yunzhi for HCC
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients who are using other chinese herbal therapies concurrently or on any other investigation agents for treatment of their cancer
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 |
|---|---|---|
| Coriolus Versicolor | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
- Background: PubMed 2990661Okuda K, Ohtsuki T, Obata H, Tomimatsu M, Okazaki N, Hasegawa H, Nakajima Y, Ohnishi K. Natural history of hepatocellular carcinoma and prognosis in relation to treatment. Study of 850 patients. Cancer. 1985 Aug 15;56(4):918-28. doi: 10.1002/1097-0142(19850815)56:43.0.co;2-e.
- Background: PubMed 2830952Falkson G, Ryan LM, Johnson LA, Simson IW, Coetzer BJ, Carbone PP, Creech RH, Schutt AJ. A random phase II study of mitoxantrone and cisplatin in patients with hepatocellular carcinoma. An ECOG study. Cancer. 1987 Nov 1;60(9):2141-5. doi: 10.1002/1097-0142(19871101)60:93.0.co;2-4.
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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.
Wei Peng Yong, MRCP, MB ChB' principal investigator
National University Hospital, Singapore
Choo Su Pin, BMBS, MRCP, M Med principal investigator
National Cancer Centre
Tan Chee Kiat, MBBS, FRCP, FAMS principal investigator
Singapore General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Coriolus Versicolor in people with Carcinoma and Therapy, run by National University Hospital, Singapore at 3 sites in Singapore.
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 13 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: stopped early, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. 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. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01097083, which also lists 2 linked publications.
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 14 Jan 2014.