Personalized First-line Chemotherapy Choice in Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitut Curie
About this trial
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
Qualifiers
Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
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.
Histologically or cytologically proven Pancreatic Ductal Adenocarcinoma (PDAC).
Metastatic disease.
Disqualifiers
Concurrent enrolment in another interventional clinical study.
Previous treatment with chemotherapy for pancreatic cancer.
Uncontrolled massive pleural effusion or massive ascites.
Known deficiency in UGT1A1 (homozygous UGT1A1*28 allele).
Trial design
Treatments tested in this trial
- Clinical value of 5 transcriptomic signatures to personalize the therapeutic decision for L1 in PDAC
- Biomarkers of tumor signatures (translational studies)
Treatment groups
85 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov