Biliary Tract Cancer
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Sep 28 – Oct 05, 2026
Prospective Phase II Study of Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma (NEOFOL).
INT J CANCER · Q1 JOURNAL - RANK #77/326
This prospective, single-arm phase II trial evaluated neoadjuvant modified FOLFOXIRI in 25 patients with potentially resectable cholangiocarcinoma, administering six cycles every two weeks with surgical resection when feasible. The primary endpoint was objective response per RECIST v1.1, with secondary endpoints including resectability, R0 resection, recurrence-free survival, overall survival, safety, and quality of life. The objective response rate was 44.0%, 80.0% were considered resectable, 64.0% underwent curative-intent resection, R0 resection was 75.0%, median recurrence-free survival was 18.93 months, and median overall survival was 26.70 months. The authors conclude that neoadjuvant mFOLFOXIRI showed promising antitumor activity, enabled high curative-intent resection rates, and had manageable toxicity, supporting further investigation.
10.1002/ijc.70758
Sep 21 – Sep 28, 2026
Five-Year Follow-Up of the Phase III ASCOT Trial of Adjuvant S-1 After Resection for Biliary Tract Cancer.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
The ASCOT phase III trial’s five-year follow-up evaluated adjuvant S-1 in 440 resected biliary tract cancer patients randomized to observation (n=222) or oral S-1 (n=218) for four cycles. At a median follow-up of 61.5 months, five-year overall survival was 64% with S-1 versus 52% with observation (HR 0.72; 95% CI 0.55-0.95; one-sided p=.01), with median OS of 8.2 versus 5.9 years. Median relapse-free survival was 6.1 years with S-1 versus 3.5 years with observation (HR 0.80; 95% CI 0.62-1.03). The authors conclude that adjuvant S-1 provides a sustained survival benefit and should be a standard treatment for resected biliary tract cancer.
10.1200/JCO-26-00017
Trastuzumab plus nivolumab with gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer: a phase 1b/2 trial.
NAT MED · Q1 JOURNAL - RANK #1/195TOP-TIER
This multi-institutional, open-label, phase 1b/2 HERBOT study evaluated a first-line quadruplet regimen of trastuzumab, nivolumab, gemcitabine, and cisplatin in participants with HER2-positive advanced biliary tract cancer. Among 40 participants, the primary endpoint was met with an objective response rate of 55% (95% CI 38.5-70.7), including one complete and 21 partial responses, and a disease control rate of 95% (95% CI 83.5-99.4). With a median follow-up of 17.0 months, median progression-free survival was 10.6 months (95% CI 7.8-17.4), median overall survival was not reached, and common grade ≥3 treatment-related adverse events included neutropenia (57.5%), anemia (30.0%), and thrombocytopenia (22.5%). The authors conclude that upfront HER2-targeted therapeutic intensification in BTC may represent a promising first-line treatment strategy warranting ongoing phase 3 investigation.
10.1038/s41591-026-04679-x