Biomarker Discovery in Patients With Advanced Biliary Tract Cancer

Using biopsy specimen (formalin fixed paraffin embedded tissue), in-house NGS and RNA-sequencing will be performed simultaneously. Through this, investigators will discover biomarkers based on multi-omics data that predict response to systemic chemotherapy (nab-paclitaxel plus gemcitabine-cisplatin). In addition, blood sampling will be performed in parallel to conduct research on cell-free DNA and circulating tumor cell analysis related to response and progression on chemotherapy; before administration of chemotherapy, 3 months after chemotherapy, 6 months after chemotherapy, the time of disease progression (if possible), before curative resection (if possible).

Inclusion criteria

• Age ≥ 19 years old
• Capable of understanding and complying with the protocol requirements and signed informed consent
• The patients were confirmed as bilary tract cancer (gall bladder cancer, extrahepatic cholangiocarcinoma, intrahepatic cholangiocarcinoma) by histopathology or cytology
• Patients with inoperable or metastatic or recurrent biliary tract cancer
• Patients who underwent in-house next-generation sequencing
• Patients planning to receive Gemcitabine, Cisplatin, nab-paclitaxel triplet chemotherapy
• At least one measurable objective lesion was identified based on the RECIST 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• The expected survival a ≥3 months

Exclusion criteria

• The subject has uncontrolled, significant intercurrent or recent illness including infection for organ failure
• Prior palliative chemotherapy for biliary tract cancer
• Dementia, altered mental state, or any mental illness that prevents understanding or informed consent
• Other conditions that researchers not think to be suitable for enrollment.