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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Institut Paoli Calmettes

Marseille, France