Occupational-related unresectable or recurrent cholangiocarcinoma
Conditions
Interventions
Nivolumab(480mg/body) is administered.
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Has diagnosed cholangiocarcinoma by histology or cytology. But, organization type isn't limited. (2)Has unresectable or recurrent cholangiocarcinoma that are refractory or intolerant to a regimen containing gemcitabine, or have refused these treatments. (3)Has occupational-related cholangiocarcinoma caused by organic solvents such as 1,2 dichloropropane and dichloromethane used in the printing business etc. (4)Age 20 years or above (5)Has one or more evaluable lesions as defined in RECIST version 1.1. (6)ECOG Performance Status of 0-2 (7)Has adequate organ function at the registration. (8)Agreed to contracept for a certain period.
Exclusion criteria
Exclusion criteria: (1)Has merger or past history of autoimmune diseases. (2)Has duplicate cancer. (3)Has metastatic lesions in the brain or meningeal membrane. (4)Has serious complications (intestinal obstruction, interstitial lung disease, diabetes etc.) (5)Has pleural or ascites, that require treatment. (6)Has poor pain control. (7)Has received antibody therapy or medication therapy in the past. (8)Has remain strongly influenced by side effects due to pretreatment or surgery. (9)Has history of serious heart disease or one with the findings. (10)Has systemic infections that require treatment. (11)Isn't pregnant or breast-feeding. (12)Judged to be in a state lacking consent ability due to merger of dementia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidences of adverse events Decrease rate of CA19-9 Disease control rate Progression-free survival Overall survival | — |
Countries
Japan
Contacts
Public ContactKumiko Umemoto
St.Marianna University School of Medicine Hospital Department of Medical Oncology
Outcome results
None listed