← 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.
Measured against the standard of care· ESGE 2026 (biliary stricture management; replaces ESGE 2018 stenting guideline) / ESGE 2025 (biliary stricture diagnosis)

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

Diagnosis is unchanged and still follows the separate ESGE diagnostic guideline (Endoscopy 2025;57:166-185). Start with MRI/MRCP plus laboratory tests, read CA19-9 only after decompression, and check IgG4 when IgG4-related sclerosing cholangitis is suspected. For distal extrahepatic strictures with no pancreatic mass, do combined same-session EUS-guided tissue acquisition plus ERCP brushing and biopsy. For perihilar strictures, sample by ERCP first and move to cholangioscopy-guided biopsy if the result is indeterminate. Do not place an uncovered SEMS (USEMS) until malignancy is confirmed. Management now follows the 2026 ESGE biliary stricture management guideline, which replaces the 2018 stenting guideline and brings it into line with the 2022 therapeutic EUS guideline. Benign: post-cholecystectomy strictures get temporary multiple plastic stents (MPSs), exchanged every 3-4 months with as many stents as possible, for about 12 months. A fully covered SEMS (FCSEMS) is an option only if the stricture is more than 2 cm below the hepatic confluence or the patient will not comply with repeated ERCPs. Anastomotic strictures after liver transplant get MPSs, or a temporary FCSEMS if more than 2 cm below the confluence. Nonanastomotic post-transplant strictures that can be treated endoscopically get MPSs plus balloon dilation if needed. Chronic pancreatitis strictures get a temporary 8-10 mm FCSEMS for 6-12 months. High-grade PSC strictures get balloon dilation alone, with no stent, because stenting adds no benefit and may add adverse events. Endotherapy is indicated for a benign stricture with liver tests raised for more than 1 month and/or cholangitis. Malignant distal: drain before surgery only selectively (cholangitis, severe jaundice or pruritus, delayed surgery). When drainage is needed before surgery or neoadjuvant therapy, or for palliation, place a 10-mm SEMS endoscopically. Endoscopic drainage is preferred over surgery or PTBD for inoperable obstruction. Malignant hilar: manage in high-volume centres with a hepatobiliary multidisciplinary team (MDT). ERCP is preferred over PTBD for preoperative drainage. Palliate Bismuth I-II with ERCP. For Bismuth III-IV, ERCP or ERCP combined with EUS-guided drainage (EUS-BD) is preferred over primary PTBD, with PTBD as a complement if needed. For proven Bismuth II-IV, aim to drain more than 50%, ideally 70% or more, of the viable nonatrophic liver volume using several routes as needed. Use plastic stents when the drainage strategy is undefined or the centre is not expert. USEMS are for expert centres when the diagnosis is proven, the tumour is unresectable, and complete drainage is predicted. After failed or unfeasible ERCP, EUS-BD is recommended over PTBD. Use hepaticogastrostomy (EUS-HGS) if there is a duodenal stricture, and EUS-HGS or choledochoduodenostomy (EUS-CDS) if there is not. PTBD is used if EUS-BD fails. In surgically altered anatomy, benign disease gets enteroscopy-assisted ERCP first; malignant disease gets enteroscopy-assisted ERCP or EUS-BD. Give antibiotics before ERCP in selected cases: predicted incomplete drainage, hilar strictures, immunocompromised patients, PSC, cholangioscopy. This follows the ESGE ERCP-adverse-events guideline. Etiology-specific care (Strasberg injuries, IgG4-SC, Mirizzi, choledochal cysts) is unchanged.

ESGE 2026 (biliary stricture management; replaces ESGE 2018 stenting guideline) / ESGE 2025 (biliary stricture diagnosis) · reviewed 2026-10-11 ↗
Oh DY … Vogel A · Journal of Hepatology · IF 40.1 · PubMed ↗Permalink
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