Evaluating Gemcitabine chemotherapy for metastatic pancreatic cancer patients with the GemCore signature
Phase IV Study Assessing Efficacy of First-Line Chemotherapy With Gemcitabine in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients Ineligible to FOLFIRINOX Treatment
This study is testing if Gemcitabine chemotherapy can help people with advanced pancreatic cancer who have a specific marker in their tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Paoli-Calmettes Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Marseille) |
| Trial ID | NCT06046794 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with metastatic pancreatic adenocarcinoma who are ineligible for FOLFIRINOX chemotherapy and have not received prior treatment in a metastatic setting.
Not a fit: Patients who have contraindications to Gemcitabine treatment or those with a poor performance status may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with metastatic pancreatic adenocarcinoma who have the GemCore signature.
How similar studies have performed: While this specific approach is novel, previous studies have shown that targeted chemotherapy can improve outcomes in specific patient populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Marseille
- Institut Paoli Calmettes — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Jihane PAKRADOUNI, Dr
- Email: drci.up@ipc.unicancer.fr
- Phone: 0491223778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.