Evaluate the progression-free survival (PFS) of benmelstobart combined with gemcitabine and cisplatin in first-line patients with advanced cholangiocarcinoma, and the progression-free survival (PFS) of benmelstobart combined with anlotinib in second-line patients with advanced cholangiocarcinoma.
Hemoglobin (HB) ≥90 g/L (without blood transfusion within 14 days prior).
Absolute neutrophil count (ANC) ≥1.5×10⁹/L.
Platelet count (PLT) ≥80×10⁹/L.
Albumin (ALB) ≥30 g/L (without albumin transfusion within 14 days prior).
None
Single group
Benmelstobart combined with gemcitabine and cisplatin
DrugBenmelstobart 1200mg, intravenous infusion on Day 1;Gemcitabine 1000mg/m², intravenous infusion over 30 minutes on Day 1 and Day 8;Cisplatin 25mg/m², intravenous infusion on Day 1 and Day 8. Maintenance dose of study medication: Benmelstobart 1200mg, intravenous infusion on Day 1;Gemcitabine 1000mg/m², intravenous infusion over 30 minutes on Day 1 and Day 8
Progression Free Survival
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
Outcome Measure
Time from randomization to death from any cause
Objective Response Rate
It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR)
Quality of life score
Quantitative scoring system for patients' self-subjective self-assessment of current symptom tolerance
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