NGS as the First-line Treatment in Advanced Biliary Tract Cancer

Inclusion Criteria

• •1. histologically confirmed locally advanced or metastatic biliary tract carcinoma (including intrahepatic bile duct, extrahepatic bile duct, gallbladder and ampulla of vater);
• •2. no history of chemotherapy or radiotherapy for biliary tract cancer, except those delivered as adjuvant setting that completed at least 6 months before documentation of recurrence by imaging study.
• •3. presence of at least one measurable tumor lesion which is defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral CT and MRI; measurable lymph nodes must be ≥15 mm in the short axis;
• •4. adequate hematopoietic function which is defined as below:
• •1. hemoglobin level ≥ 9 g/dL;
• •2. absolute neutrophil count (ANC) ≥ 1,500/mm3;
• •3. platelet count ≥ 100,000/mm3;
• •5. adequate hepatic function which is defined as below:
• •1. total bilirubin \< 2 mg/dL;
• •2. Alanine aminotransferase (ALT) ≤ 3 x ULN; ≤ 5 x ULN if liver metastasis
• •6. adequate renal function: creatinine clearance rate (CCr) ≥ 50 mL/min ((based upon Cockroft-Gault formula or 24-hour urine collection); \< Cockroft-Gault formula \> Male: ((140 - age) × weight \[kg\])/(72 × serum creatinine\[mg/dL\]) Female: 0.85 x estimate for male
• •7. age of 20 years or above;
• •8. ECOG performance status 0-1;
• •9. life expectancy of at least 12 weeks;
• •10. patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.
• •11. ability to understand and willingness to sign a written informed consent document.