BACKGROUNDBiliary tract cancer (BTC) represents a heterogeneous disease spectrum associated with an unfavorable prognosis. A combination of immunotherapy and chemotherapy has become a new standard strategy for advanced BTC. However, understanding the association between genomic alterations and outcomes of immunotherapy in BTC is crucial for further improving clinical benefits.METHODPatients with metastatic BTC were included in this study retrospectively, who received PD-1/PD-L1 (ICI) antibodies combined with chemotherapy. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included overall response rate (ORR) and disease control rate (DCR). Additionally, we conducted exploratory analysis of genomic alterations and biomarkers.RESULTSNinety-one patients were enrolled in this study. The patients were divided into two groups: albumin paclitaxel + S1 (AS) + PD-1 (n = 56) group and GC + ICI (n = 35) group. There were no significant differences in terms of PFS, ORR, and DCR between the two groups. Regarding biomarker analysis, 44 patients had positive PD-L1 expression, with a mPFS of 4.8 months and an ORR of 15.9%. Surprisingly, 29 patients had negative PD-L1 expression, with a mPFS of 9.9 months and an ORR of 27.6%. The average tumor mutational burden (TMB) was 4.5 mutations per megabase (mut/MB) for patients with microsatellite-stable (MSS) tumors. There was no significant difference in PFS between patients with TMB high and low (cutoff = 4.5 mut/MB). Genomic analysis revealed TP53 (n = 13, 43.3%), KRAS (n = 8, 26.7%), NTRK1/2/3 (n = 8, 26.7%), isocitrate dehydrogenase (IDH) 1/2 (n = 6, 20.0%), PIK3CA (n = 6, 20.0%), BRCA2 (n = 5, 16.7%), MDM2/4 (n = 5, 16.7%), and BRAF (n = 4, 13.3%) as the most common gene alterations. MDM2/4 mutations were associated with shorter survival (p < 0.05).CONCLUSIONGC plus immunotherapy is still the standard of care for late stage BTC. PD-L1 expression and TMB were not good predictors for selecting patients who would benefit more from immunotherapy plus chemotherapy.

01 Jun 2025·Journal of Critical Care

Microcirculation properties of 20 % albumin in sepsis; a randomised controlled trial

Article

Author: Garduno, Alexis ; Martin-Loeches, Ignacio ; Zilahi, Gabor ; Connolly, Elizabeth ; Coakley, John Davis ; Cusack, Rachael A F ; Cantan, Ben ; Rodríguez, Alejandro

INTRODUCTIONSepsis and septic shock are associated with microcirculatory dysfunction, significantly impacting patient outcomes. This study aimed to evaluate the effects of a 20 % albumin bolus on microcirculation compared to crystalloid resuscitation in fluid-responsive patients (ClinicalTrials.govID:NCT05357339).METHODSWe conducted a single-centre randomised controlled trial, enrolling 103 patients (Albumin n = 52, Control n = 51). Fluid responsiveness was assessed, and fluid was administered in boluses of 100 ml to clinical effect. Microcirculation was measured using the Side stream Dark Field camera and AVA 4.3 software. Baseline characteristics, macrohaemodynamics, and microcirculation parameters were recorded. Three patients were excluded from analysis.RESULTSThe final cohort comprised 100 patients, 35 (35 %) females with a mean age of 58 years (range: 18-86). The mean APACHE score was 28 (range: 7-45), and the mean SOFA score was 9.4 (range: 1-17). No significant differences in APACHE (26.24 vs. 29.4, p = 0.069) or SOFA (9.08 vs. 9.78, p = 0.32) scores were found for albumin and control group respectively. The albumin group had worse microcirculation at baseline but demonstrated significant improvements in microvascular density and activity at 15 min and 60 min (p < 0.005), while the control group exhibited no significant changes. Additionally, both groups were fluid responsive, with a mean pulse pressure variability of 17 % at admission. There were no significant differences in overall fluid balances, vasopressor days, length of ICU stay, or mortality between groups.CONCLUSIONThis study demonstrates that a 20 % albumin bolus significantly enhances microcirculation in fluid-responsive patients with septic shock. These findings underscore the potential benefits of targeted microcirculation therapy in critically ill patients.

01 Jun 2025·Journal of Critical Care

One step toward the understanding of potential albumin benefits in septic patients

Article

Author: Chousterman, Benjamin G ; Leone, Marc ; Favory, Raphaël

100 Deals associated with Albumin(IDIBAPS)

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Indication	Highest Phase	Country/Location	Organization	Date
Inflammation	Preclinical	Spain	Institut d'Investigacions Biomèdiques August Pi i Sunyer	13 Apr 2019
Liver Diseases	Preclinical	Spain	Institut d'Investigacions Biomèdiques August Pi i Sunyer	13 Apr 2019

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