Trastuzumab in HER2-positive Biliary Tract Cancer

Inclusion criteria

• The subject with disease that is not amendable to a curative treatment approach or locally advanced or metastatic or unresectable CCC with histological diagnosis
• At least one measurable(per RECIST 1.1) lesion
• Primary or metastatic tumor with HER2 positive defined on IHC2+, FISH+ or IHC3+
• ECOG Performance status 0 or 1
• At least 3 months for life expectancy Common inclusion criteria
• Men or women over 19 years at time of signing ICF
• Signed Informed Consent Form

Exclusion criteria

• Received prior chemotherapy for advanced/metastatic disease (the adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrolled will be accepted)
• Not recovery from toxicities related to any prior treatments excluding alopecia (eg, neurological toxicity to ≥ Grade 2)
• History of malignancy other than CCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death, such as carcinoma in situ or thyroid papillary carcinoma Hematology, chemistry or organ function
• ANC < 1.5 × 109/L, or Platelet < 100 × 109/L
• Total bilirubin > 1.5 × ULN; or AST/ ALT > 2.5 × ULN (or if the tumor has expanded into the liver, > 5 × ULN); or, alkaline phosphatase > 2.5 × ULN (or > 5 × if the tumor has expanded into the liver, or > 10 × ULN if the tumor has expanded into the brain without liver,); or albumin < 2.5 g/dL
• Creatinine clearance < 60 mL/min(calculated using the Cockcroft-Gault formula) Other exclusion criteria related to IP
• History of proved congestive heart failure; angina with medication; evidence of transmural myocardial infarction on ECG; uncontrolled hypertension(systolic> 180 mmHg or diastolic> 100 mmHg); clinically significant heart valve disease; uncontrolled arrhythmia
• LVEF < 50% (calculated by cardiac sonography or MUGA)
• Subject with rest dyspnea due to metastatic tumor or other disease or who needs oxygen therapy
• Chronic or high-dose corticosteroid treatment
• Clinically significant Hearing impairment Common exclusion criteria
• History or evidence of CNS metastases
• Interstitial pneumonia or pulmonary fibrosis with symptom and exact lesion on chest X-ray
• Hearing loss
• Uncontrolled significant systemic disease (eg, infection or uncontrolled DM)
• Pregnant or lactating females
• Sexually active fertile subjects without contraception
• Treatment with other investigational therapy within 4 weeks prior to initiation of study treatment
• Radiotherapy within 4 weeks prior to initiation of study treatment (the rest at least 2 weeks after palliative radiotherapy for bone metastasis and recovery from the effects of radiation will be accepted.)
• Major surgery within 4 weeks prior to initiation of study treatment
• History of HIV and active HBV or HCV
• Previously identified allergy or hypersensitivity to components of the study treatment formulations