A study to investigate the effect of a Chinese herb formula on liver cancer is to be carried out at the Memorial Sloan-Kettering Cancer Center in New York.
The Japanese compound, called Sho-Saiko-to, is made up of seven Chinese herbs and is manufactured by Honso Pharmaceutical Company, headquartered in Nagoya, Japan.
Liver cancer has a low success rate when treated but previous Japanese research on Sho-saiko-to has demonstrated its hepatoprotective, antiproliferative and immunostimulant effects in vitro.
In a randomised trial, cirrhotic patients receiving Sho-saiko-to had a lower incidence of developing HCC and a greater survival rate compared to those given a placebo. Honso claims that there is sufficient clinical evidence on Sho-saiko-to, especially with respect to dosage, to warrant a Phase II trial. The drug has so far shown capability primarily to inhibit tumour proliferation rather than to kill tumour cells.
The trial has been approved by the Food and Drug Administration (FDA).
Patients scheduled for ablative therapy will be assessed for eligibility and administered 7.5g of granular extract per day of Sho-saiko-to. The outcome used to power the trial is survival at 15 months, the median survival of a historical cohort. For purposes of secondary analyses, liver function, alpha-fetoprotein and intervention-free survival will be compared between the treated cohort and historical data.
The patients, approximately 80 in number, will be treated over a two year period, and then their progress followed for another year.