← Issue №1/ week of Jun 24, 2026/Pancreas/Biliary

Durvalumab with gemcitabine-based chemotherapy regimens in advanced biliary tract cancer: primary results from the phase IIIb TOURMALINE study.

From GI Signals issue №1: what this paper found, what it changes, and where it sits against the current standard of care, reviewed by Simon Mathews, MD.

Pancreas/Biliary prospective cohort · n=142 · Jul 6, 2026 · J Hepatology · IF 40.1

Durvalumab with gemcitabine-based chemotherapy regimens in advanced biliary tract cancer: primary results from the phase IIIb TOURMALINE study.

New evidencecholangiocarcinoma
Clinical takeawayDurvalumab added to gemcitabine-based chemotherapy is already standard first-line care for advanced biliary tract cancer (TOPAZ-1); TOURMALINE supports its safety and efficacy across a broader range of gemcitabine-based regimens rather than establishing a new, unadopted therapy.
What it foundDurvalumab plus gemcitabine-based chemotherapy regimens showed manageable safety (50.7% Grade 3/4 PRAEs) and efficacy (median OS 13.50 months, ORR 33.1%) in advanced biliary tract cancer.
ContextThis study expands on TOPAZ-1 by evaluating durvalumab with seven gemcitabine-based regimens, confirming its feasibility and efficacy in a broader, real-world population with advanced biliary tract cancer.
Emergingsuggested applicable standard· European Society of Gastrointestinal Endoscopy (ESGE), "Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline, Updated October 2017", Endoscopy 2018;50(9):910-930

Decision at staketreatment options for advanced biliary tract cancer

No single passage of this standard matched the paper closely enough to quote, so none is shown. The standard is cited above.

Our full summary of this standard

Distinguish benign from malignant biliary strictures using cross-sectional imaging (MRI/MRCP preferred over contrast-enhanced CT) plus laboratory tests, interpreting CA19-9 after biliary decompression and never relying on tumor markers alone; check serum IgG4 when IgG4-related sclerosing cholangitis is suspected (HISORt criteria). Per the ESGE 2024 diagnostic work-up guideline, tissue-acquisition strategy now branches by stricture location rather than following one linear sequence: for DISTAL extrahepatic strictures with jaundice and no pancreatic mass, combined same-session EUS-guided tissue acquisition (EUS-TA, end-cutting FNB needle) plus ERCP-based tissue acquisition (standard brush cytology plus fluoroscopy-guided biopsy) is the strongly preferred first-line approach; for PERIHILAR strictures, obtain brush cytology plus fluoroscopy-guided biopsy at index ERCP, escalate indeterminate strictures to cholangioscopy-guided biopsy (with intraductal ultrasound/confocal laser endomicroscopy selectively), and reserve EUS-TA for cases where ERCP-based sampling is insufficient and curative resection is not feasible and/or extraluminal disease is accessible; escalate any positive or indeterminate feature to multidisciplinary tumor board. Manage benign anastomotic and chronic-pancreatitis strictures with a fully-covered self-expanding metal stent for 6-12 months (multiple plastic stents when FCSEMS is contraindicated, hepaticojejunostomy if refractory). Treat cholangitis with biliary obstruction as an indication for urgent biliary drainage, but do not instrument every obstructed sector: for hilar or multisegmental strictures (Bismuth II-IV), ESGE suggests draining ≥50% of the liver volume and avoiding opacification of biliary ducts that will not be drained (weak recommendation, low-quality evidence), because post-ERCP cholangitis frequently complicates injection of obstructed ducts that are not subsequently drained, whereas drainage of >50% of liver volume is associated with less cholangitis and longer survival; ESGE suggests antibiotic prophylaxis before biliary stenting in selected patients (e.g., immunocompromised patients, expected incomplete biliary drainage; weak recommendation, moderate-quality evidence), with a full antibiotic course if adequate drainage is not achieved during the procedure. Direct etiology-specific care for Strasberg bile-duct injuries, post-transplant strictures (ASGE 2023: ERCP preferred over PTBD, covered SEMS preferred over multiple plastic stents), IgG4-sclerosing cholangitis, Mirizzi syndrome, and choledochal cysts.

European Society of Gastrointestinal Endoscopy (ESGE), "Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline, Updated October 2017", Endoscopy 2018;50(9):910-930 · reviewed 2026-07-20 ↗
Oh DY … Vogel A · Journal of Hepatology · IF 40.1 · PubMed ↗Permalink
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