A Phase II Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection
Cholangiocarcinoma is a highly fatal disease with poor prognosis. While Cholangiocarcinoma
is generally rare in Western countries, it is more common in Korea, with an estimate of 3500
cases diagnosed annually. Currently, surgical resection remains the only potentially
curative treatment, but many patients develop recurrence. Thus, effective postoperative
adjuvant therapy is required to prolong survival in patients with cholangiocarcinoma.
However, no standard postoperative treatment has been established yet.
Among several different new anticancer drugs currently being investigated in the treatment
of advanced biliary tract cancer, gemcitabine has generated particular interest. The
nucleoside analogue gemcitabine has been reported to be active against advanced unresectable
cholangiocarcinoma including cancer of the gallbladder, intrahepatic, and extrahepatic bile
duct. So this is expected to be investigated in the adjuvant setting.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary objective: To investigate the proportion of patients who are recurrence-free for 2 years
Jan 2010 - Jan 2014 (24 month enrollment, 24 month follow-up)
Woo Jin Lee, MD
National Cancer Center, Korea
Korea: Food and Drug Administration