Panitumumab monotherapy for gemcitabine, TS-1 and CDDP tolerant or failure unresectable or recurrent cholangiocarcinoma, evaluation of safety and efficiency
- Conditions
- cholangiocarcinoma
- Registration Number
- JPRN-UMIN000006047
- Lead Sponsor
- Division of Hepato-Biliary Pancreatic Surgery , Tohoku University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Not provided
(1)Previous history of chemotherapy with anti-EGFR antibody (2)Tumor is controllable with any other therapy (SD, PR, CR, NE in RECIST ver.1.1) (3)Previous history of infusion reaction by antibody drug (4)Serious complications (e.g. severe hypertension, severe heart failure, severe coronary artery disease, myocardial infarction within 3 months, severe hepatic failure, poorly controlled diabetes, plumonary fibrosis, interstitial pneumonia or renal failure with dialysis) (5) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy (6)Pregnant or lactating women or women of childbearing potential (restrict lactating within 8 weeks after last Panitmumab administration) (7)Patient with severe drug allergy (8)Psychosis or severe mental disorder (9)Inadequate physical condition, as diagnosed by primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate (CR+PR)
- Secondary Outcome Measures
Name Time Method Severe adverse events Progression free survival (PFS) Time to progression (TTP) Overall survival (OS) Median survival time (MST) Disease control rate (DCR) adverse events