Hepatocellular carcinoma (HCC) is one of the most common cancers in the world1. HCC risk
increases drastically in patients with chronic hepatitis B infection, hepatitis C infection
or liver cirrhosis. HCC is very prevalent in our region due to endemic hepatitis B
infection and increasing incidence of hepatitis C.
Patients with HCC have very poor prognosis because HCC tumors are usually non-symptomatic.
Most patients will not be diagnosed until the disease has reached an advanced stage.
Chemotherapy may offer palliative benefit to some patients with advanced HCC but has not
been shown to prolong survival in these patients. HCC patients are in need for innovative
and targeted therapies. Therefore, we propose to study gefitinib as an adjuvant therapy in
patients with resected HCC.
Gefitinib blocks the function of epidermal growth factor receptor which is a key factor in
stimulating liver cancer growth. In mice, gefitinib has been shown to reduce the size of
liver cancer. It also had anti tumor activity in patients with various cancers including
HCC. Gefitinib can relieve disease-related symptoms in these patients. Overall, gefitinib
is a very well tolerated treatment and is suitable for long-term use.
At the time of diagnosis and surgical evaluation, patients with resectable hepatocellular
carcinoma will be asked to participate in this study.Patients will be registered after
consent form is obtained. Patient is asked to donate tumor tissues, urine and blood
samples.Tumorand normal specimens are collected at the time of surgery. After patient
recovers from surgery (4-6 weeks) and fullfills the eligiblity, patient will receive
gefitinib 250 mg p.o. daily for 6 months.
Patient will remain on study till completion of treatment. The following are conditions when
your study doctor will remove you from the study or stop the therapy:
1. Interruption of treatment for 4 consecutive weeks due to side effects, which do not
2. withdraw of consent by patient. ii. Your disease becomes worse. iii. New information
that gefitinib treatment is harmful to patients has become available.
Patient will be evaluated at one month, 3 months and 6 months on gefitinib. After that,
evaluate patient at least every 3 months for first 2 years, then every 6 months for next 3
years, then yearly afterwards. Draw blood and store sera and urine at the same interval
until relapse and/or death. Conduct correlative studies of urine, serum and tumor tissue
with clinical outcome.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
To study the changes of selected genetic or protein markers through the treatment and find out whether some of them can be potential biomarkers for disease relapse.
Alex Chang, M.D.
CEO and Medical Director Of Johns Hopkins Singapore International Medical Center
United States: Institutional Review Board