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Can a Tumor's genomic signature predict who benefits from gemcitabine?

NCT ID NCT06046794

Disease control Sponsor: Institut Paoli-Calmettes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 29, 2026 · Last updated Sep 30, 2026 · Updated 1 time

Summary

Researchers are studying whether gemcitabine chemotherapy helps people with metastatic pancreatic cancer whose tumors carry a specific genomic pattern called the GemCore signature. The study enrolls adults who cannot receive FOLFIRINOX, a stronger chemotherapy combination, and who are starting gemcitabine as their first treatment for metastatic disease. Participants consent to a genomic analysis of their tumor tissue to confirm the GemCore signature, then receive gemcitabine as part of standard care. The study tracks survival, tumor response, and how long patients live without their cancer worsening.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
gemcitabine chemotherapy
What this could lead to
If gemcitabine works well in tumors with the GemCore signature, doctors could use a simple genomic test to pick the right chemotherapy for patients who cannot tolerate FOLFIRINOX.
What could go wrong
This is a single-arm study with no comparison group, so it cannot prove gemcitabine is better than other options. Pancreatic cancer is aggressive and often resists chemotherapy, and the GemCore signature may not reliably predict who responds.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer of pancreas

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, France

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