Coriolus Versicolor as Palliative Therapy Compared to Placebo in Patients With Child-Pugh C Unresectable Hepatocellular Carcinoma

January 13, 2014 updated by: National University Hospital, Singapore

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 169610
        • National Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Investigators

  • Principal Investigator: Wei Peng Yong, MRCP, MB ChB', National University Hospital, Singapore
  • Principal Investigator: Choo Su Pin, BMBS, MRCP, M Med, National Cancer Centre
  • Principal Investigator: Tan Chee Kiat, MBBS, FRCP, FAMS, Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

March 30, 2010

First Submitted That Met QC Criteria

March 31, 2010

First Posted (Estimate)

April 1, 2010

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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