Pharmacokinetic Study of Adjuvant Gemcitabine Therapy for Biliary Tract Cancer after Hepatectomy (KHBO1101)

Pharmacokinetic Study of Adjuvant Gemcitabine Therapy for Biliary Tract Cancer after Hepatectomy (KHBO1101) - Pharmacokinetic Study of Gemcitabine after Hepatectomy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005109

Enrollment

Registered

2011-04-01

Start date

2011-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Cancer

Interventions

Pharmacokinetic measurement in administration of gemcitabine after Hepatectomy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed biliary tract cancer 2)Underwent resection with hepatectomy 3)Over 20 years old 4)Eastern Cooperative Oncology Group performance status of 0-1 5)No history of earlier chemotherapy or radiotherapy 6)Adequate organ function 7)All patients provided written informed consent

Exclusion criteria

Exclusion criteria: 1)History of severe drug allergy 2)Severe comorbid disease(pulmonary fibrosis or interstitial pneumonia, etc.) 3)Active infection 4)Known to be positive for hepatitis B and C virus 5)Pregnant of breastfeeding

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of gemcitabine and gemcitabine metabolites	—

Secondary

Measure	Time frame
Relationship between the pharmacokinetics of gemcitabine and gemcitabine metabolites and adverse events	—

Countries

Japan

Contacts

Public ContactYutaka Fujiwara

Kobe university hospital Medical Oncology/Hematolog

fu_ji_@yahoo.co.jp0783825111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026