Personalized First-line Chemotherapy Choice in Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures
This study tests whether analyzing tumor genes can help doctors choose the best first-line chemotherapy for advanced pancreatic cancer. Rather than using the same treatment for all patients, researchers will use genetic signatures to personalize which chemotherapy regimen (FOLFIRINOX or Gemcitabine-nab-paclitaxel) each patient receives, potentially improving treatment response rates.
Key Objective: The trial aims to improve response rates to first-line chemotherapy by matching patients to the most effective drug regimen based on their tumor's genetic characteristics.
Who to Consider: Patients with newly diagnosed advanced pancreatic ductal adenocarcinoma who have not yet received chemotherapy should consider enrolling.
Trial Parameters
Brief Summary
The aim of this study is to assess the clinical value of 5 transcriptomic signatures prognostic of chemotherapeutic sensitivity to improve the Objective Response Rate (ORR) of first-line (L1). Chemotherapy regimen (FOLFIRINOX vs Gem-nabP) will be selected based on transcriptomic signatures applied to the pre-therapeutic liver biopsy of newly diagnosed PDAC patients.
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations. 2. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 3. Histologically or cytologically proven Pancreatic Ductal Adenocarcinoma (PDAC). 4. Metastatic disease. 5. Measurable or evaluable lesions according to RECIST v1.1 criteria. 6. First-line therapy (previous neoadjuvant/adjuvant chemotherapy not allowed). 7. Age ≥ 18 years (no upper limit, patients ≥ 75 years old must have a G8 score ≥ 14). 8. 3\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. 9. Availability of tumor tissue sample from the primary pancreatic tumor or liver metastasis (chemo-naïve) before inclusion in step 1. 10. Adequate organ function, as defined by the following (blood test ≤ 7 days prior to inclusion): 1. Serum aspartat