Metabolomic and Immune-Microbiome Profiling for Unresectable Pancreatic Cancer

Brief Summary The goal of this observational study is to identify biomarkers and develop a personalised treatment stratification model for patients with unresectable pancreatic ductal adenocarcinoma (PDAC) in Taiwan. The main questions it aims to answer are: * What serum metabolomic profiles predict treatment response and patient survival? * How do immune response markers and gut microbiome composition correlate with therapeutic outcomes? * Can a combined multi-omic stratification algorithm enhance personalised therapy planning? Participants, who have been diagnosed with unresectable locally advanced or metastatic PDAC and are undergoing systemic therapy and chemoradiotherapy, will: * Provide serum samples for comprehensive metabolomic profiling via high-performance liquid chromatography-mass spectrometry. * Undergo immune profiling through flow cytometry. * Provide stool samples for gut microbiome analysis using 16S rRNA sequencing. * Be followed longitudinally to correlate these multi-omic findings with clinical outcomes. Researchers anticipate that integrating these multi-omic analyses will facilitate personalised therapy approaches, potentially improving patient outcomes.

NCT Number	NCT07036978
Lead Sponsor	Chang Gung Memorial Hospital
Conditions	Pancreatic Ductal Adenocarcinoma (PDAC)
Enrollment	140 participants
Start Date	2026-05-01
Primary Completion	2028-07-31 (estimated)
Study Completion	2033-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-15