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NCT Number: NCT06046794

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

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.

Recruiting

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Key information

Conditions

Cancer of Pancreas Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Analyze of GemCore status

Other

Genomic analyze of GemCore status

Primary outcomes

  1. Percentage of alive GemCore+ patients treated with Gemcitabine

    Time frame: 12 months

    Percentage of alive GemCore+ patients treated with Gemcitabine

Secondary outcomes

  1. Overall survival

    Time frame: 24 months

    Overall survival

  2. Tumor response rate

    Time frame: 24 months

    Tumor response rate

  3. Progression-free survival

    Time frame: 24 months

    Progression-free survival

Other outcomes

  1. Overall survival of GemCore- patients

    Time frame: 24 months

    Overall survival of GemCore- patients

Study contacts

Contact information is provided by the study sponsor or research team.

Jihane PAKRADOUNI, Dr

CONTACT

[email protected]

0491223778

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Acronym: GemSign-01

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2023
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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