About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Teripalimab
- Gemcitabine + Cisplatin
- Surgery