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A Phase II Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection

Phase 2
18 Years
Open (Enrolling)

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Trial Information

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.

Inclusion Criteria:

- Subjects undergoing curative surgical resection for cholangiocarcinoma (including
cancer of the gallbladder [except stage I], intrahepatic, and extrahepatic bile duct)

- Histological confirmation is mandatory.

- Age over 18 years old

- Performance status (ECOG scale): 0-2

- Adequate organ functions Hb ≥ 9.0 g/dl ANC: ≥ 1,500/mm3 PLT ≥ 100,000 /mm3 Liver
function: Total Bilirubin ≤ 2.0 mg/dl AST / ALT / ALP ≤ 3× upper limit of normal
Creatinine ≤ 1.5 ULN

- Patients should sign a written informed consent before study entry.

Exclusion Criteria:

- Tumor type other than adenocarcinoma

- Stage I gallbladder cancer

- Noncurative surgical resection including R2 resection

- Other primary malignancy (except in situ carcinoma of the cervix or adequately
treated basal cell carcinoma of the skin or prior malignancy treated more than 5
years ago without recurrence)

- Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive

- Prior radiotherapy

- Major surgery within 4 weeks prior to study treatment except for surgical resection
of cholangiocarcinoma

- Serious illness or medical conditions, as follows; congestive heart failure (NYHA
class III or IV) unstable angina or myocardial infarction within the past 6 months,
significant arrhythmias requiring medication and conduction abnormality such as over
2nd degree AV block uncontrolled hypertension hepatic cirrhosis(≥ Child class B)
interstitial pneumonia, pulmonary adenomatosis psychiatric disorder that may
interfere with and/or protocol compliance unstable diabetes mellitus uncontrolled
ascites or pleural effusion active infection

- Received any investigational drug or agent/procedure, i.e. participation in another
trial within 4 weeks before beginning treatment with study drug

- Pregnant or lactating woman

- Women of child bearing potential not using a contraceptive method

- Sexually active fertile men not using effective birth control during medication of
study drug and up to 6 months after completion of study drug if their partners are
women of child-bearing potential

- Any patients judged by the investigator to be unfit to participate in the study

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary objective: To investigate the proportion of patients who are recurrence-free for 2 years

Outcome Time Frame:

Jan 2010 - Jan 2014 (24 month enrollment, 24 month follow-up)

Safety Issue:


Principal Investigator

Woo Jin Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


Korea: Food and Drug Administration

Study ID:




Start Date:

January 2010

Completion Date:

December 2015

Related Keywords:

  • Cholangiocarcinoma
  • Cholangiocarcinoma