This study is a prospective, observational study designed to analyze the safety, tolerability, and efficacy of first-line treatment using the combination of gemcitabine and cisplatin plus anti-PD-1/PD-L1 antibodies for patients with advanced cholangiocarcinoma.
This is a prospective cohort study of combination anti-PD-1/PD-L1 antibodies plus Gemcitabine and Cisplatin chemotherapy for adult patients (≥18) with advanced cholangiocarcinoma Gemcitabine and Cisplatin (GC): This chemotherapy doublet has been the historical standard of care for advanced cholangiocarcinoma. It works by interfering with DNA synthesis and causing DNA cross-linking, leading to tumor cell apoptosis. Anti-PD-1/PD-L1 antibodies: Immunotherapy (including pembrolizumab, durvalumab, envafolimab, tislelizumab, etc.) is designed to block the PD-1/PD-L1 immune checkpoint pathway, thereby reinvigorating T-cells to recognize and attack tumor cells. Recent pivotal trials (e.g., TOPAZ-1, KEYNOTE-966) have demonstrated that adding immunotherapy to GC chemotherapy significantly improves overall survival compared to chemotherapy alone. This study aims to evaluate the real-world safety, tolerability, and clinical efficacy of this combination regimen in specific clinical practice settings for unresectable late-stage cholangiocarcinoma patients.
Study Type
OBSERVATIONAL
Enrollment
50
Anti-PD-1/PD-L1 Intravenous injection for at least 6 months
Gemcitabine and cisplatin Intravenous injection for at least 6 months
Zhongshan Hospital Fudan university
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence of adverse events
Safety will be monitored by addressing and recording all adverse events (AEs), serious adverse events (SAEs) and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Time frame: Up to 30 days after last treatment dose
Objective response rate(ORR)
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 5 years
Progression free survival(PFS)
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 5 years
To the relief time (TOR)
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: Time Frame: 5 years
Duration of relief(DOR)
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: 5 years
Disease Control Rate (DCR)
Evaluated by researchers based on the RECIST 1.1 standard
Time frame: Time Frame: 5 years
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