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Phase I/II Study of Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer

Phase 1/Phase 2
20 Years
Open (Enrolling)
Biliary Tract Cancer

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Trial Information

Phase I/II Study of Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer

Biliary tract cancer is one of the most lethal malignancies worldwide, with surgery
representing the only potentially curative treatment for this disease. However, many
patients are diagnosed too late for curative resection, and even if surgery can be
performed, the likelihood of relapse is very high. Over the past decade, gemcitabine has
been widely used to treat unresectable or recurrent biliary tract cancer patients. In the
ABC-02 study, the first prospective multicenter phase III study in this field,
gemcitabine/cisplatin combination chemotherapy was compared with gemcitabine monotherapy and
found that the combination regimen significantly prolonged MST (from 8.1 to 11.7 months; P <
0.001). Gemcitabine/cisplatin combination therapy is now considered to be the standard
regimen for advanced biliary tract cancer. S-1 is an oral fluoropyrimidine prodrug that has
confirmed efficacy against various solid tumors, both alone and in combination with other
cytotoxic drugs. S-1 monotherapy has yielded good results against advanced biliary tract
cancer and gemcitabine/S-1 combination therapy has yielded promising results with acceptable
toxicity levels for patients with advanced biliary tract cancer. In this study, we aimed to
determine the safety and efficacy of adding S-1 to gemcitabine/cisplatin combination regimen
for advanced biliary tract cancer.

Inclusion Criteria:

- 1. Patients with cytologically or histologically proved biliary tract cancer 2. age
>=20 years 3. PS 0-2 4. No prior history of chemotherapy or radiotherapy. Patients
who have undergone adjuvant chemotherapy are eligible if at least 6 months have
passed since the last administration.

5. Adequate bone marrow function (neutrophil count >=1,500/mm3, and platelet count
>=100,000/mm3), liver function (total bilirubin >=3 mg/dL and AST/ALT >=150 IU/L),
and renal function (creatinine clearance >=60 mL/min) 6.No other serious comorbid
disease 7.Adequate oral intake 8.Provided written informed consent

Exclusion Criteria:

- 1. Patients with interstitial pneumonia or pulmonary fibrosis 2. Patients with
uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of
myocardial infarction within 3 months 3. Patients with severe active infection 4.
Patients who are pregnant or lactating, or have an intention to get pregnant 5.
Patients with a history of severe drug allergy 6. Patients with other serious
comorbid disease 7. Patients with mental disease 8. Patients who are judged
inappropriate for the entry into the study by the principle doctor 9. Patients with
watery diarrhea

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

one year survival rate

Outcome Description:

The primary endpoint is designated to evaluate overall survival rate at 12-month. Secondary endpoints include response rate according to RECIST 1.1 and the incidence of adverse events evaluated by CTCAE v 4.0.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Etsuro Hatano, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Kyoto University


Japan: Institutional Review Board

Study ID:




Start Date:

December 2010

Completion Date:

August 2013

Related Keywords:

  • Biliary Tract Cancer
  • Biliary Tract Neoplasms