NCT06046794 Efficacy of First-Line Gemcitabine Chemotherapy in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients
| NCT ID | NCT06046794 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Paoli-Calmettes |
| Condition | Cancer Of Pancreas |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-05-23 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-05-23 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06046794 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer Of Pancreas. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06046794 currently recruiting?
Yes, NCT06046794 is actively recruiting participants. Contact the research team at drci.up@ipc.unicancer.fr for enrollment information.
Where is the NCT06046794 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT06046794 clinical trial?
NCT06046794 is sponsored by Institut Paoli-Calmettes. The trial plans to enroll 100 participants.
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