Efficacy of First-Line Gemcitabine Chemotherapy in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients (GemSign-01)

Institut Paoli-Calmettes

Status

Enrolling

Conditions

Cancer Of Pancreas

Treatments

Other: Analyze of GemCore status

Study type

Interventional

Funder types

Other

Identifiers

NCT06046794

GemSign-01-IPC 2022-068

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.