Metabolomic and Immune-Microbiome Profiling for Unresectable Pancreatic Cancer

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Conditions studied: Pancreatic Ductal Adenocarcinoma (PDAC)

In brief

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.

Key facts

Study ID

NCT07036978

Run by

Chang Gung Memorial Hospital

People needed

140

Starts

2026-05-01

Expected to finish

2033-07-31

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unresectable disease status determined by a multidisciplinary tumour board (either locally advanced disease encasing critical vessels or distant metastases present).
• Planned initiation of systemic therapy (first-line chemotherapy or chemo + experimental immunotherapy trial) as part of standard care - this ensures a uniform starting point for outcome measurement.
• Adequate organ function to undergo therapy (renal, hepatic, bone marrow parameters within acceptable range) and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, indicating patients well enough to participate and undergo required blood draws and sample collection.
• Ability to provide informed consent, with no severe comorbid conditions that would preclude study procedures (e.g. unable to provide stool sample or undergo blood draws).

You may not qualify if…

• Prior systemic therapy for metastatic PDAC.
• Current use of long-term antibiotics or probiotics that could significantly alter the gut microbiome unless they are willing to pause these interventions (to avoid confounding in microbiome analysis).
• Co-existing active malignancy that could confound metabolomic or immune readouts, unless it is a low-grade, early cancer in remission.

Where it is running

• Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan

Full record on ClinicalTrials.gov

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