RecruitingNot ApplicableNCT05475366

Personalized First-line Chemotherapy Choice in Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures

Pilot Study of Personalized First-line Chemotherapy Choice for Patients With Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures (PACsign)


Sponsor

Institut Curie

Enrollment

85 participants

Start Date

Dec 12, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is using genetic analysis of tumor tissue (called transcriptomic profiling) to personalize which chemotherapy regimen is most likely to work for each patient with advanced pancreatic cancer, instead of using the same treatment for everyone. **You may be eligible if...** - You have been diagnosed with advanced (metastatic) pancreatic ductal adenocarcinoma — the most common type of pancreatic cancer - You have not yet received chemotherapy for your advanced cancer - You are 18 or older in good overall health (ECOG 0–1) - Tumor tissue is available for genetic testing **You may NOT be eligible if...** - You have previously received chemotherapy for metastatic disease (prior adjuvant/neoadjuvant chemotherapy is not allowed) - You have severe organ dysfunction (liver, kidneys, bone marrow) - You have a specific enzyme deficiency (DPD deficiency) that makes certain chemotherapy drugs dangerous - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERClinical value of 5 transcriptomic signatures to personalize the therapeutic decision for L1 in PDAC

Formalin-Fixed Paraffin-Embedded (FFPE) samples will be centralized in which nucleic acids extraction (DNA+RNA) and FFPE-compatible RNA-sequencing will be performed in real-time (≤28 days). RNAseq reads will be processed and all 5 transcriptomic signatures will be applied for prediction of response to 5FU, oxaliplatin, irinotecan, gemcitabine and taxane. In addition, biomarkers status will be obtained for all patients as part of good clinical practice.

OTHERBiomarkers of tumor signatures (translational studies)

Blood (serum and plasma) will be drawn at baseline, week 8, and tumor progression in order to look for surrogate biomarkers of tumor signatures in liquid biopsy


Locations(7)

Hôpital Beaujon

Clichy, France

Hôpital HENRI MONDOR

Créteil, France

Hôpital Claude Hurriez

Lille, France

Institut Paoli-Calmettes

Marseille, France

CHU Robert Debré

Reims, France

Institut Curie

Saint-Cloud, France

Hôpital PAUL BROUSSE 12 Avenue Paul Vaillant Couturier

Villejuif, France

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NCT05475366


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