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PhaseI study of the combination of gemcitabine, cisplatin and S-1 in advanced biliary tract cancer

Phase 1
Conditions
advanced biliary tract cancer
Registration Number
JPRN-UMIN000006548
Lead Sponsor
ational Cancer Center Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
24
Inclusion Criteria

Not provided

Exclusion Criteria

1) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 3) Psychosis 4) Patients requiring systemic steroids medication 5) Interstitial pneumonia 6) Active bacterial or fungous infection 7) Severe complication 8) Patients who cannot receive neither iodic drug nor gadolinium because of drug allergy 9) Inadequate physical condition, as diagnosed by primary physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Safety
Secondary Outcome Measures
NameTimeMethod
response rate, progression-free survival, overall survival
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