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Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer

Phase 1
20 Years
Open (Enrolling)
Biliary Tract Cancer

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Trial Information

Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer

There is no standard adjuvant therapy after liver hemi-hepatectomy due to bile duct cancer,
because of high surgical morbidity ratio and high adverse event ratio of adjuvant therapy.
For example, our preliminary results showed that regular gemcitabine administration
(1000mg/m2, day1, 8, 15 every 4 weeks) after hemihepatectomy was too toxic and induced
severe leukocytopenia and/or thrombocytopenia. Herein, we planned this study to decide more
safety adjuvant protocol(recommend dose) for gemcitabine and S-1 after hemihepatectomy using
continual reassessment method analysis. In this study, we decided that tolerable ratio of
dose-limiting toxicity would be less than 10%.

Inclusion Criteria:

1. Biliary tract cancer (>= UICC Stage IB)

2. R0 or R1 resection due to biliary tract cancer (BTC)

3. ECOG performance status must be 0 or 1

4. The patient underwent no other treatment than surgery for BTC

5. Neutrophil must be over 1500/μl, platelet must be over 100,000/μl, AST and ALT must
be less than five times the normal limit, total bilirubin must be less than three
times the normal limit, and creatinin must be less than 1.2 mg/dl.

6. The patient can intake drugs per os.

7. From 4 to 12 weeks after the surgery

8. Written informed consent

Exclusion Criteria:

1. Existence of active double cancer

2. The patient suffered from severe drug allergy

3. Sever complications (interstitial pneumonia, heart failure, renal failure, liver
failure, ileus, incontrollable diabetes mellitus, and so on)

4. Any active infections exist.

5. Pregnancy

6. Severe mental disorder

7. Others

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

frequency in adverse events

Outcome Description:

The purpose of this study is to decide maximum tolerated dose and recommended dose. Recommended dose is a dose which would induce dose-limiting toxicity in 10% of participants. This will be calculated by continual reassessment method.

Outcome Time Frame:

up to 12 weeks

Safety Issue:


Principal Investigator

Hiroaki Nagano, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Osaka University, Graduate School of Medicine


Japan: Institutional Review Board

Study ID:




Start Date:

December 2010

Completion Date:

May 2013

Related Keywords:

  • Biliary Tract Cancer
  • Biliary Tract Neoplasms