This is a single-arm, open, Phase II clinical study of Tislelizumab combined with lenvatinib and Gemox regimen for transformational treatment of potentially resectable locally advanced malignant tumors of biliary system.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Chemotherapy regimen: Gemcitabine 1g/m2 Oxaliplatin 100mg/m, D1, q3W2 Tislelizumab 200mg D1 Q3w Lenvatinib 4mg Po QD
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
R0 resection rate
Time frame: 5 months
Progression-free survival (PFS)
Time frame: 18 months
Disease control rate (DCR)
Time frame: 5 months
Objective response rate (ORR)
Time frame: 5 months
Overall survival (OS)
Time frame: 24 months
Improvement in quality of life as measured by the EORTC Quality of Life Questionnaire QLQ-C30 (V3.0)
Time frame: 24 months
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