Efficacy of First-Line Gemcitabine Chemotherapy in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients

Study Overview
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Brief Summary
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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 their tumor. The main question it aims to answer is to assess efficacy of Gemcitabine (tumor response, survival rate) in the population of patient bearing the GemCore signature. Participants will start the chemotherapy with Gemcitabine as usually performed in standard care of their center. They will consent to a genomic analyze of their tumor to know if it bears the GemCore signature. The center will manage the participant's follow up as usually realized in standard care.

Official Title
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Phase IV Study Assessing Efficacy of First-Line Chemotherapy With Gemcitabine in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients Ineligible to FOLFIRINOX Treatment

Conditions
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Cancer Of Pancreas

Intervention / Treatment
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* Other: Analyze of GemCore status


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metastatic pancreatic adenocarcinoma patients<br>Analyze of GemCore status | Other: Analyze of GemCore status<br>* Genomic analyze of GemCore status<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of alive GemCore+ patients treated with Gemcitabine | Percentage of alive GemCore+ patients treated with Gemcitabine | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival | 24 months | 
| Tumor response rate | Tumor response rate | 24 months | 
| Progression-free survival | Progression-free survival | 24 months |