The aim of this study is to assess the efficacy and safety of durvalumab combined with S-1 as adjuvant therapy of resectable Biliary Tract Cancer(BTC) with high risk of recurrence
Radical surgical resection is still the most important radical treatment for biliary tract tumors, and the postoperative recurrence rate of BTC patients remains high. It is particularly important to choose appropriate and effective adjuvant treatment. This study is a single center, single arm, prospective, phase II clinical study. This study plans to include 40 BTC patients after radical resection. The patients are evaluated by a multidisciplinary team (MDT) as high risk of recurrence. Adjuvant therapy with durvalumab combined with S-1 should be started no more than 12 weeks after radical surgery. These patients will first receive 8 cycles of adjuvant therapy and the regimens consist of durvalumab and S-1, with a 21-day dosing cycle. After 8 cycles of adjuvant therapy, if the patients do not experience disease recurrence or intolerance,then the patients wil receive 6 cycles of adjuvant therapy in maintenance therapy stage. The regimen of andjuvant therapy is durvalumab with 28-day dosing cycle. If the patients experience recurrence, the subsequent treatment plan will be determined by the researchers based on treatment guidelines.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The treatment regimen for this study is as follows: First 8 cycles of adjuvant therapy: Durvalumab 1500mg, (Day 1, IV, Q3W) and S-1 40mg/m2 (Day1-14, BID, Q3W), up to 8 cycles. Maintenance therapy stage(6 cycles):If the patients do not experience disease recurrence or intolerance after first 8 cycles of adjuvant therapy, then, Durvalumab 1500mg, (IV, Q4W), up to 6 cycles
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
2-year recurrence-free survival rate
The 2-year recurrence-free survival rate refers to the proportion of patients who did not experience disease recurrence within 2 years after surgery.
Time frame: 2 years
Overall survival(OS)
It is the time from the start of treatment to the death of the patient due to any cause.
Time frame: 3 years
Recurrence-free survival(RFS)
It is the time from surgery to the earliest disease recurrence of the patient.
Time frame: 2 years
3-year overall survival rate(3-year OS rate)
The proportion of patients who did not die with any cause within 3 years after receiving treatment.
Time frame: 3 years
Safety and tolerability by incidence, severity and outcome of adverse events
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0
Time frame: 3 years
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