RecruitingNot ApplicableNCT06046794

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

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


Sponsor

Institut Paoli-Calmettes

Enrollment

100 participants

Start Date

May 23, 2024

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether a specific genetic tumor profile called "GemCore+" can predict which patients with metastatic pancreatic cancer will respond well to gemcitabine chemotherapy. The goal is to use tumor genetics to better match patients to the right treatment. **You may be eligible if...** - You are 18 or older - You have metastatic pancreatic adenocarcinoma confirmed by biopsy - You are about to start first-line chemotherapy with gemcitabine (and are not a candidate for the more intensive FOLFIRINOX regimen) - Enough tumor tissue is available for genetic analysis - You have a life expectancy of more than 2 months **You may NOT be eligible if...** - You have already received treatment for metastatic pancreatic cancer - Your general health is too poor (ECOG performance status 3 or higher) - You have a contraindication to gemcitabine 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

OTHERAnalyze of GemCore status

Genomic analyze of GemCore status


Locations(1)

Institut Paoli Calmettes

Marseille, France

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NCT06046794


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