The Efficacy and Safety of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma

Inclusion Criteria:

• Age, years: 18-70
• Histologically and cytologically confirmed advanced biliary tract adenocarcinoma,unresectable, measurable lesions according to RECIST criteria; ECOG score of 0-1; lifeexpectancy ≥12 weeks;
• Untreated; more than 6 months after the last adjuvant chemotherapy (does not includetaxanes and S1);
• Laboratory examination within 14 days before entering the study should meet followingrequirements: ANC ≥ 1.5 x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90g/L (9g/dL); AST, ALT ≤ 2.5 x ULN (with noliver metastasis), ≤ 5 x ULN（with liver metastasis); creatinine ≤ 1.5 x ULN; TBIL ≤ 1.5 xULN
• Both male and female subjects of potential fertility have to agree effective birthcontrol during the entire study
• Informed consent

Exclusion Criteria:

• Concurrent other effective treatment (including radiotherapy)
• Resectable patients
• Allergy history to other drugs in the same class patients with pregnancy or lactation
• Known severe internal medical diseases
• Abnormal heart function or relevant history of myocardial infarction and severearrhythmia
• Immunocompromised patients, such as HIV positive
• Uncontrollable mental illness
• Other conditions the researchers considered ineligible for the study