Actively Recruiting
Personalized First-line Chemotherapy Choice in Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures
Led by Institut Curie · Updated on 2026-05-01
85
Participants Needed
7
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalized First-line Chemotherapy Choice in Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Willing and able to follow the study protocol including treatment and visits
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma
- Metastatic disease present
- Measurable or evaluable lesions by RECIST v1.1 criteria
- First-line therapy only (no prior neoadjuvant or adjuvant chemotherapy)
- Age 18 years or older (patients 75 years or older must have a G8 score of 14 or higher)
- ECOG Performance Status 0 or 1
- Available tumor tissue sample from primary tumor or liver metastasis before inclusion
- Adequate organ function based on recent blood tests (within 7 days)
- No Dihydropyrimidine dehydrogenase (DPD) deficiency
- Life expectancy of at least 3 months
- Women must be post-menopausal or have negative pregnancy tests if pre-menopausal
- Registered in a National Health Care System
You will not qualify if you...
- Enrolled in another interventional clinical study
- Prior chemotherapy treatment for pancreatic cancer
- Uncontrolled massive pleural effusion or ascites
- Known homozygous UGT1A1*28 allele deficiency
- Active infections requiring systemic therapy, including tuberculosis, hepatitis B or C, SARS-CoV-2, or HIV
- Diagnosis of a second malignancy within the last 3 years except certain treated skin or cervical cancers
- Known active central nervous system metastases or carcinomatous meningitis (stable treated brain metastases allowed)
- Uncontrolled serious illnesses (heart failure, coronary disease, peripheral artery disease, severe COPD, decompensated cirrhosis, gastrointestinal conditions with diarrhea, psychiatric illness or social issues affecting compliance)
- Live vaccine within 30 days before study treatment
- Known allergy or hypersensitivity to study drugs or excipients
- Conditions or abnormalities that may interfere with trial participation or safety
- Radiotherapy to more than 30% of bone marrow or wide-field radiation within 4 weeks
- Major surgery within 4 weeks prior to study treatment
- Pregnancy or breastfeeding
- Legal protection or guardianship status preventing informed consent
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Hôpital Beaujon
Clichy, France, 92210
Actively Recruiting
2
Hôpital HENRI MONDOR
Créteil, France, 94010
Actively Recruiting
3
Hôpital Claude Hurriez
Lille, France, 59037
Actively Recruiting
4
Institut Paoli-Calmettes
Marseille, France, 13573
Actively Recruiting
5
CHU Robert Debré
Reims, France, 51092
Actively Recruiting
6
Institut Curie
Saint-Cloud, France, 92210
Actively Recruiting
7
Hôpital PAUL BROUSSE 12 Avenue Paul Vaillant Couturier
Villejuif, France, 94800
Actively Recruiting
Research Team
C
Cindy NEUZILLET, MD, PhD
CONTACT
M
Marie-Emmanuelle Legrier
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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