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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To decide maximum tolerated dose and/or recommended dose of Gemcitabine or S-1 adjuvant therapy after hemihepatectomy

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kansai Hepatobiliary Oncology Group
• Treatments: Gemcitabine

Criteria

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