This study will evaluate the efficacy and safety of 1st line therapy with gemcitabine plus S1 and tislelizumab in participants with advanced biliary tract carcinoma (BTC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Gemcitabine (1000 mg/m2) will be administered by IV infusion on Day 1and Day 8 of each 21-day cycle
S1 (60 mg/day if body surface area \< 1.25 m2, 80 mg/day if body surface area = 1.25\~1.50 m2) will be administered by PO on Day 1 \~ 14 of each 21-day cycle
Tislelizumab (200 mg) will be administered by IV infusion on Day 1 of each 21-day cycle
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, China
Objective response rate (ORR)
Time frame: Baseline up to approximately 6 months
Progression free survival (PFS)
Time frame: baseline up to approximately 12 months
1-year survival rate
Time frame: baseline up to approximately 12 months
Disease control rate (DCR)
Time frame: baseline up to approximately 6 months
Duration of response (DoR)
Time frame: baseline up to approximately 12 months
Percentage of participants with SD ≥ 4 weeks
Time frame: baseline up to approximately 6 months
3-month progression free survival rate
Time frame: baseline up to approximately 3 months
6-month progression free survival rate
Time frame: baseline up to approximately 6 months
6-month overall survival rate
Time frame: baseline up to approximately 6 months
12-month overall survival rate
Time frame: baseline up to approximately 12 months
Quality of life (QoL)
Time frame: baseline up to approximately 12 months
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