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RecruitingNCT06046794GemSign-01Updated Sep 29, 2026

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

An interventional study of Analyze of GemCore status in Cancer Of Pancreas, sponsored by Institut Paoli-Calmettes. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Institut Paoli-Calmettes · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Cancer Of Pancreas
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    metastatic pancreatic adenocarcinoma patients

    Analyze of GemCore status

    Other: Analyze of GemCore status

Interventions

  • OtherAnalyze of GemCore status

    Genomic analyze of GemCore status

05

What researchers measure

Primary outcomes

  1. Percentage of alive GemCore+ patients treated with Gemcitabine

    Percentage of alive GemCore+ patients treated with Gemcitabine

    Time frame: 12 months

Secondary outcomes

  1. Overall survival

    Overall survival

    Time frame: 24 months

  2. Tumor response rate

    Tumor response rate

    Time frame: 24 months

  3. Progression-free survival

    Progression-free survival

    Time frame: 24 months

Other outcomes

  1. Overall survival of GemCore- patients

    Overall survival of GemCore- patients

    Time frame: 24 months

06

Study locations

1 of 1 sites recruiting
  • Institut Paoli Calmettes
    Marseille, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06046794
Lead sponsor
Institut Paoli-Calmettes
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
May 23, 2024
Primary completion
Nov 2029 (estimated)
Completion
Nov 2029 (estimated)
Last update
Sep 29, 2026

Study contacts

Jihane PAKRADOUNI, Dr
Contact
drci.up@ipc.unicancer.fr
0491223778

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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