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

NCT06046794 | Recruiting

• 1 other identifier: GemSign-01-IPC 2022-068
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Of Pancreas

Outcome Measures

Primary Outcomes (1)

• Percentage of alive GemCore+ patients treated with Gemcitabine

  Percentage of alive GemCore+ patients treated with Gemcitabine

  12 months

Secondary Outcomes (3)

• Overall survival

  24 months

• Tumor response rate

  24 months

• Progression-free survival

  24 months

Other Outcomes (1)

• Overall survival of GemCore- patients

  24 months

Study Arms (1)

metastatic pancreatic adenocarcinoma patients

EXPERIMENTAL

Analyze of GemCore status

Other: Analyze of GemCore status

Interventions

Analyze of GemCore status OTHER

Genomic analyze of GemCore status

metastatic pancreatic adenocarcinoma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli Calmettes

Marseille, France

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Jihane PAKRADOUNI, Dr

CONTACT

0491223778; drci.up@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 21, 2023
• Study Start: May 23, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)