Treatment of Advanced Biliary Tract Cancer: ASCO Living Guideline, Version 2026.1.0
In brief
ASCO recommends immunotherapy plus chemotherapy first for mismatch repair-proficient biliary cancer
The 2026 living guideline recommends immune checkpoint inhibitors with chemotherapy as first-line treatment for advanced biliary tract cancer that is mismatch repair-proficient and microsatellite-stable. It also calls for broad tumor DNA and RNA testing at diagnosis to identify targeted treatment options; plasma testing is generally reserved for when tissue is unavailable. Which treatment fits depends on tumor biomarkers and eligibility.
- Journal
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology (Q1)
- Published
- 14 October 2026
- Study design
- Practice guideline / consensus
- Evidence level
- Level 1, High (CEBM 1c)
- Authors
- Rachna T Shroff, Erin B Kennedy, Ashley Efrain Alarcon Rozas, Rajiv Agarwal, Melinda Bachini, Marina Baretti, et al.
- PMID
- 42874012
- DOI
- 10.1200/JCO-26-02462
Why clinicians should know about it
- Picked for Surgical Oncology (top studies of the week, 18 October 2026): Guideline recommends chemo and biomarkers
Abstract
PURPOSE: This living guideline provides recommendations for liquid biopsy and treatment of patients with advanced biliary tract cancer. METHODS: The American Society of Clinical Oncology convened an Expert Panel to conduct a systematic review of relevant studies and develop recommendations for liquid biopsy and systemic therapy for patients with advanced biliary tract cancer. RESULTS: Six studies provided estimates of concordance between liquid biopsy and tissue biopsy. Nine RCTs were included in the evidence base for first-line therapy. One phase III RCT and four phase II RCTs were included in the evidence for second-line chemotherapy. Eleven single studies or reviews supported biomarker-specific second-line therapy recommendations. RECOMMENDATIONS: Testing with broad-based tissue DNA and RNA NGS testing to determine the presence of targetable biomarkers is recommended at the time of diagnosis at any stage. Liquid biopsy with plasma is generally recommended only when tissue biopsy is unavailable. As first-line therapy for patients with pMMR/MSS advanced BTC, immune checkpoint inhibitors (ICIs) plus chemotherapy is recommended. Options for patients with advanced BTC who are not candidates for ICIs are included in the guideline. Pembrolizumab monotherapy is an option for patients with dMMR/MSI-H advanced BTC. For patients with disease progression on first-line treatment and who have no identified biomarkers, FOLFOX with active symptom control, or active symptom control alone are recommended; options for patients who are ineligible for oxaliplatin-based chemotherapy are included in the guideline. Second-line therapy options are recommended for patients with dMMR/MSI-H, IDH1 mutations, FGFR2 fusions or rearrangements, BRAF V600E mutations, HER2 overexpression, RET, NTRK1/2/3, or NRG1 fusions.Additional information is available at https://ascopubs.org/guidelines/living-guidelines.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.