Clinical trials of HCC in Taiwan

Tumors of the liver represent one of the most common malignancies in the world. Little has changed in the past 5 years to alter the statistics. Published census from the Department of Health in Taiwan, 1993, showed that cancer death was 107/100,000 population. Hepatoma is the number one cause of cancer death with 24.05/100,000 population. It increased 11.23% in comparison with last year's survey. About 5,000 people die from hepatoma each year in Taiwan. Both case control studies and cohort studies have shown a strong association between chronic hepatitis B carriage rate and an increased incidence of hepatocellular carcinoma (HCC). Although up to a 200-fold excess incidence of HCC was found in Taiwan, the association of chronic hepatitis B virus in different populations of Southeast Asia who have HCC is somewhat varied. Many treatment modalities for hepatoma have been attempted. Chemotherapy is usually given to patients with metastatic disease or for persistent or recurrent disease. The consensus is that no single drug or combination of drugs given systemically leads to a reproducible response rate of more than 25% or has any effect on survival, or survival beyond that of untreated control. The identification of new, effective chemotherapy drugs and other modality treatments for advanced stage HCC is urgently required. We report here the results regarding response rates, toxicities, and survivals of 14 on-going and finished Phase I, II and III clinical trials on hepatoma. These include chemotherapy and/or biological modifier, radioisotope, hormone, and hepatic infusion. Nine future therapies and gene therapies will also be discussed.