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

Last updated: June 10, 2025
Sponsor: Institut Paoli-Calmettes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Adenocarcinoma

Treatment

Analyze of GemCore status

Clinical Study ID

NCT06046794
GemSign-01-IPC 2022-068
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Metastatic pancreatic adenocarcinoma histological proved

  • FOLFIRINOX chemotherapy-ineligible patient and going to receive first-linemetastatic chemotherapy with gemcitabine monotherapy

  • Tumor material allowing assessment of GEMCore status (i.e. FFPE block with tumorcellularity ≥ 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

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 orsafeguard of justice);

  • Unable to undergo medical follow-up for geographical, social or psychologicalreasons.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Analyze of GemCore status
Phase:
Study Start date:
May 23, 2024
Estimated Completion Date:
November 01, 2027

Connect with a study center

  • Institut Paoli Calmettes

    Marseille,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.