Status:
RECRUITING
Efficacy of First-Line Gemcitabine Chemotherapy in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Cancer Of Pancreas
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this interventional study is to learn about the efficacy of first-line chemotherapy with Gemcitabine in metastatic pancreatic adenocarcinoma patients expressing the GemCore signature in th...
Eligibility Criteria
Inclusion
- Metastatic pancreatic adenocarcinoma histological proved
- FOLFIRINOX chemotherapy-ineligible patient and going to receive first-line metastatic chemotherapy with gemcitabine monotherapy
- Tumor material allowing assessment of GEMCore status (i.e. FFPE block with tumor cellularity ≥ 10%);
- Life expectancy \> 2 months;
- Measurable target according to RECIST 1.1 criteria;
- No previous treatment in metastatic situation;
- Age ≥ 18 years;
- Patient not opposed to study participation;
- Affiliation to a social security system, or beneficiary of such a scheme.
Exclusion
- Contraindication to Gemcitabine treatment;
- ECOG performance status ≥ 3;
- Person in emergency situation or unable to express non-opposition;
- Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice);
- Unable to undergo medical follow-up for geographical, social or psychological reasons.
Key Trial Info
Start Date :
May 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06046794
Start Date
May 23 2024
End Date
November 1 2027
Last Update
June 11 2025
Active Locations (1)
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1
Institut Paoli Calmettes
Marseille, France