This study is designed to combine anti-angiogenic drugs on the basis of PD-L1+ gemcitabine/cisplatin, hoping to further improve the curative effect of advanced BTC treatment and provide more choices for first-line treatment of BTC in China.
1.Age range from 18 to 80 years old, regardless of gender;
2.Histologically confirmed, unresectable advanced or metastatic BTC including cholangiocarcinoma (intrahepatic or extrahepatic), gallbladder carcinoma.
3. Patients who have not received systematic treatment for BTC in the past .
4.At least one measurable lesion (according to RECIST v1.1 requirements).
1. Histologically diagnosed as neuroendocrine carcinoma;
2. People who are allergic to adebelizumab, apatinib, gemcitabine, cisplatin or their auxiliary materials;
3. Systemic treatment in the past;
4. Pleural effusion, pericardial effusion or ascites accompanied by clinical symptoms and judged by the researcher to require frequent drainage;
Single group
Adebrelimab
Drugadepelizumab ,1200mg, q3w
Apatinib
Drugapatinib，250mg，QD
gemcitabine and cisplatin
Drugcisplatin 25mg/m2，gemcitabine 1000mg/m2 d1,d8，q3w
Progression-free Survival
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by the Investigator per RECIST Version 1.1.
Overall Survival(OS)
Overall Survival(OS) is defined as the time from the date of the first dose of study intervention until death due to any cause. The measures of interest are median Overall Survival(OS) and Overall Survival at 12 months(OS12).
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR per RECIST Version 1.1.
Duration of Response(DOR)
Duration of Response(DOR) is defined as the time from the date of first documented response until the date of documented progression per RECIST 1.1 as assessed by the investigator or death due to any cause.
Incidence of treatment-emergent adverse events(AEs)
Incidence of treatment-emergent adverse events(AEs), including possible related adverse events(PRAEs), adverse event of special interests(AESIs), immune-mediated adverse events(imAEs), and serious adverse events(SAEs).
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