Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis

Korábbi kezelés

• Received prior systemic therapy (chemotherapy or any other anti-cancer agent) in the advanced setting. Patients who received adjuvant chemotherapy after surgical resection of early stage disease are eligible.
• Currently receiving anti-cancer therapy (chemotherapy or any other anti-cancer agent)
• Not fit for combination chemotherapy as judged by the investigator

Egyéb

• Absence of distant or lymph node metastases. Patients with borderline resectable or locally advanced PDAC are not eligible.
• Presence of brain metastases
• Female patients with positive pregnancy test
• Patients who are not safe to include in the study as judged by the investigator for any medical or non-medical reason
• Unable to comply with study assessments and follow-up

• Histological and/or radiological diagnosis of metastatic PDAC. Patients without a histological diagnosis of PDAC must undergo confirmatory tumour biopsy prior to treatment start date.
• Planned for first-line systemic therapy with FOLFIRINOX or GP, either in routine care or in combination with an investigational agent(s) within a clinical trial.
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Adequate organ function
• Life expectancy of \> 90 days as judged by the investigator
• Ability to give informed consent
• Measurable disease by RECIST 1.1
• Presence of a tumour lesion amenable to core needle biopsy as judged by a staff interventional radiologist. A minimum of 3 tumour cores must be safely obtainable under CT or US guidance.
• Fit enough to safely undergo a tumour biopsy as judged by the investigator
• Ability to lie supine for \> 60 minutes
  • Patients in the archival cohort must also fulfil the following criteria:
• Archival tumour sample available (either a previous tumour diagnostic biopsy or resection specimen)