This study was a randomized controlled trial to evaluate the efficacy and safety of toripalimab combined with GemCis (gemcitabine and cisplatin) as preoperative neoadjuvant therapy for resectable ICC at high risk of recurrence.
Age ≥ 18, male or female;
Can not received systemic treatment before participating in the study;
ECOG PS score 0-1;
The main organs function normally, and there is no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases.
Patients who received PD-1, PD-L1, PD-L2, CTLA-4 before enrollment, or directly received another stimulatory or co inhibitory T cell receptor (such as CTLA-4, 0X40, CD137);
Any other research drugs within 4 weeks before enrollment;
Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy);
Congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection;
Parallel
Teripalimab
Drug240mg intravenous injection, D1, q3w, for 9 weeks (3 cycles)
Gemcitabine + Cisplatin
DrugGemcitabine 1000mg/m2 + cisplatin 25mg/m2, D1\&D8, q3w, for 9 weeks (3 cycles)
Surgery
Procedure/SurgeryRadical resection
1-year recurrence-free survival rate
1-year OS
2-year OS
ORR
DCR
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