Evaluating Gemcitabine chemotherapy for metastatic pancreatic cancer patients with the GemCore signature

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to assess the efficacy of first-line chemotherapy using Gemcitabine in patients with metastatic pancreatic adenocarcinoma who express the GemCore signature in their tumors. Participants will receive standard Gemcitabine treatment while their tumor samples will be analyzed to confirm the presence of the GemCore signature. The study will monitor tumor response and survival rates to determine the effectiveness of this treatment approach in this specific patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institut Paoli Calmettes
  Marseille, France Recruiting

Study contacts

• Study coordinator: Jihane PAKRADOUNI, Dr
• Email: drci.up@ipc.unicancer.fr
• Phone: 0491223778

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.