Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01097083
Other study ID # 3
Secondary ID
Status Terminated
Phase Phase 2
First received March 30, 2010
Last updated January 13, 2014
Start date April 2010
Est. completion date October 2013

Study information

Verified date January 2014
Source National University Hospital, Singapore
Contact n/a
Is FDA regulated No
Health authority Singapore: Domain Specific Review Boards
Study type Interventional

Clinical 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


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Coriolus Versicolor


Locations

Country Name City State
Singapore National Cancer Centre Singapore
Singapore National University Hospital Singapore
Singapore Singapore General Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Falkson 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. — View Citation

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. — View Citation

See also
  Status Clinical Trial Phase
Recruiting NCT05283226 - Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy Phase 2
Active, not recruiting NCT04362072 - Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer Phase 4
Completed NCT04033991 - Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.
Recruiting NCT02292641 - Beyond TME Origins N/A
Not yet recruiting NCT02907606 - Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study N/A
Completed NCT02507544 - A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer Phase 1
Completed NCT01942200 - A Non Interventional Study With Oxaliplatin Onkovis (Oxaliplatin) Utilized for the Treatment of Cancer
Completed NCT01061645 - Study of MOC31-PE in Antigen Positive Carcinomas Phase 1
Terminated NCT00557596 - A Phase 1-2, XIAP Antisense AEG35156 With Gemcitabine in Patients With Advanced Pancreatic Cancer Phase 1/Phase 2
Completed NCT00532155 - A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer Phase 3
Completed NCT00216372 - Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis Phase 3
Recruiting NCT06022757 - Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19) Phase 1/Phase 2
Recruiting NCT05520281 - Short-term Psychodynamic Psychotherapy in Serious Physical Illness N/A
Recruiting NCT05752357 - The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.
Not yet recruiting NCT05023928 - Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for Esophagus Cancer Phase 1
Completed NCT00446446 - PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer) Phase 2
Recruiting NCT04566952 - Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Phase 2
Not yet recruiting NCT06112041 - The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0) Phase 2
Completed NCT03562897 - Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer Phase 2
Recruiting NCT06013111 - An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors Phase 1