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This study used molecular profiling to examine gene changes and characteristics in patients with pancreatic cancer, aiming to support better treatment selection. It included patients aged 18 and older with locally advanced or metastatic pancreatic ductal adenocarcinoma who were suitable for biopsy and about to receive first-line systemic treatment. It was a non-phase study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Patients must have a histological or radiological diagnosis of locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with borderline resectable disease are not eligible. * Patient must have a tumor lesion that is amenable to a core needle biopsy. * Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied. * Patients must be fit enough to safely undergo a tumor biopsy. * Age 18 years or older. * Eastern Cooperative Group (ECOG) performance status of 1 or less. * Life expectancy of greater than 90 days. * Patients must have normal organ and marrow function * Patients must undergo systemic treatment with m-FOLFIRINOX or nab-paclitaxel as a first line standard systemic palliative treatment or combination treatment with m-FOLFIRINOX or nab-paclitaxel with or without other investigational agents within a clinical trial as a first line palliative treatment. * Ability to understand and willing to sign a written informed consent document. Exclusion Criteria: * Patients with one or more contraindications to tumor biopsy. * Patients who have prior systemic treatment (chemotherapy or any other anti-cancer agent) in advanced setting. * Patients who are currently on anti-cancer treatment including chemotherapy. * Patients with known brain metastases. * Patients with advanced PDAC who are going to be treated with gemcitabine monotherapy in advanced setting. * Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.