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Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer
Sponsor: Seoul National University Hospital
Summary
\<Research Hypothesis\> The dynamics of immune systems by cytotoxic chemotherapy and its changes by combination with immuno-oncology agents will be uncovered. The combination of Durvalumab/Tremelimumab with gemcitabine/cisplatin chemotherapy is feasible and efficacious in chemo-naïve biliary tract cancer. \<Purpose of the study\> To assess the effect of Durvalumab/Tremelimumab in combination with gemcitabine/cisplatin on response rate (RR) in chemo-naïve advanced biliary tract cancer patients.
Official title: Biomarker-oriented Study of Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2017-02-25
Completion Date
2024-12-31
Last Updated
2024-04-19
Healthy Volunteers
No
Conditions
Interventions
Durvalumab
Durvalumab 1.12 g iv on D1 every 3 weeks
Tremelimumab
Tremelimumab 75mg iv on D1 every 3 weeks
Gemcitabine
Gemcitabine 1000 mg/m2 iv on D1\& D8 every 3 weeks
Cisplatin
Cisplatin 25 mg/m2 iv on D1\& D8 every 3 weeks
Locations (1)
Seoul National University Hospital
Seoul, South Korea