Phase III Clinical Trial

Large-scale inclusion of patients (hundreds or thousands), usually international multisites collaborative trials that aim to objectively establish the medication’s efficacy,
indications, and interactions. Thus, this phase of trial often requires the highest
amount of money, manpower and resources. Involving larger numbers of patients (ie, hundreds or thousands), Phase III trials are usually international, multicenter, collaborative trials that aim to objectively establish the medication’s efficacy, indications and interactions. Thus, Phase III trials often require the largest amount of financial, manpower and other resources. Medications that have obtained satisfactory results after completion of the Phase III trial can apply for formal marketing with national regulatory authorities.



Based on the findings of the Phase II clinical trial in cancer patients, experts in the Drug Evaluation Board of the Health Bureau unanimously approved the conduct of a Phase III randomized clinical trial of Coriolus Versicolor PSP in 14 hospitals. The trial was conducted between April 1996 and September 1997.


A total of 650 patients with stomach, oesophagus or lung cancer participated in this study. Routine treatments provided included surgery, chemotherapy and/or radiotherapy.

Usage and Treatment Course

Similar to the Phase II clinical trial, patients were stratified by type of
cancer then randomized into control group, treatment group, or nonrandomized
treatment group (unblended group). Patients in each group received Coriolus Versicolor PSP concomitant with chemotherapy or radiotherapy. Mean duration of treatment was 2 months.


  • The overall efficacy rate (ie, percentage of patients demonstrating a treatment response) was 85.8%.
  • Symptoms – including fatigue and weakness, loss of appetite, nausea and vomiting, dry mouth and sore throat, spontaneous sweating and night sweats, and pain – improved after treatment with Coriolus Versicolor PSP.
  • Coriolus Versicolor PSP helped maintain quality of life and performance status in cancer patients after chemotherapy and radiotherapy.
  • IL-2 levels increased after treatment.
  • Maintenance of immunity was observed with Coriolus Versicolor PSP treatment.
  • No adverse reaction on cardiac, liver and renal functions were observed.