This phase II trial studies how well gemcitabine, cisplatin, nab-paclitaxel and durvalumab work before surgery in treating participants with Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC. Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy and Durvalumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
25mg/m2;d1, 8, 21 d cycle
1000mg/m2;d1, 8, 21 d cycle
100mg/m2;d1, 8, 21 d cycle
1000mg;d1, 21 d cycle
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGRate of completion of all preoperative and operative therapy
Completion of all therapy rate will be recorded.
Time frame: Up to 9 weeks after study start
Incidence of adverse events
Will be monitored using method of Thall, Simon and Estey, and will be tabulated by the maximum reported Common Terminology Criteria for Adverse Events (CTCAE) grade.
Time frame: Up to 1 years after study start
Response rate defined as the percentage of patients who will have complete response (CR), partial response (PR) or stable disease (SD) after the neoadjuvant therapy
Will be evaluated according to Response Evaluation Criteria in Solid Tumor (RECIST).
Time frame: Up to 9 weeks after study start
Rate of R0 resection
R0 resection is defined as no tumor remains at the cutting edge and no tumor cells remain at the cutting edge under the microscope
Time frame: Up to 9 weeks after study start
Recurrence-free survival (RFS)
RFS is defined as the time between the date of surgery and the date of disease recurrence or death, whichever occurred first. If a patient did not have an event (i.e. disease recurrence or death) by the time of final analysis, patient will be censored at the last disease evaluation time.
Time frame: Up to 1 years after study start
Overall survival (OS)
OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.
Time frame: Up to 1 years after study start
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