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

Launched by INSTITUT PAOLI-CALMETTES · Sep 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a chemotherapy drug called Gemcitabine for patients with advanced pancreatic cancer that shows a specific genetic signature known as the GemCore signature. The main goal is to see how well Gemcitabine can help shrink tumors and improve survival in these patients. If you have metastatic pancreatic adenocarcinoma and are not suitable for a different type of chemotherapy called FOLFIRINOX, you might be eligible to participate in this study.

To take part, you need to be at least 18 years old and have confirmed metastatic pancreatic cancer without any previous treatment for it. Participants will receive Gemcitabine as part of their standard care, and your tumor will be tested to confirm the presence of the GemCore signature. Throughout the trial, your doctors will monitor your health and treatment progress, just like they would for regular care. This study is currently looking for participants, and you can consider joining if you meet the criteria and are interested in potentially contributing to important cancer research.

Gender

ALL

Eligibility criteria

• 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.