Considering that the poor prognosis of resected biliary tract cancer and negative impact on the survival outcomes of R1/R2 resection, neoadjuvant chemotherapy may improve R0 resection rates and the survival outcomes of patients with resectable biliary tract cancer. The addition of durvalumab to gemcitabine/cisplatin as neoadjuvant chemotherapy may improve the R0 resection rates compared to gemcitabine/cisplatin in patients with localized biliary tract cancer. In this phase 2 trial, a total of 45 patients with localized biliary tract cancer will be 2:1 randomized to durvalumab plus gemcitabine/cisplatin or gemcitabine/cisplatin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Neoadjuvant Durvalumab + Gemcitabine/Cisplatin
Neoadjuvant Gemcitabine/Cisplatin
Asan Medical Center
Seoul, South Korea
Ro resection rate
Surgical resection without any residual cancer
Time frame: 4 months
Overall survival
Time between the start of study treatment and any cause of death
Time frame: 1 year
Event-free survival
Time between the start of study treatment and disease progression or any cause of death
Time frame: 1 year
Adverse events
Number of patients experiencing adverse events graded by National Cancer Institute Common Terminology Criteria version 5
Time frame: 13 months
Response rate
Graded by Response Evaluation Criteria in Solid Tumors version 1.1
Time frame: 4 months
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