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

Cancer Of Pancreas Clinical Trial

— GemSign-01  

Official title:

Phase IV Study Assessing Efficacy of First-Line Chemotherapy With Gemcitabine in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients Ineligible to FOLFIRINOX Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06046794
• Other study ID #: GemSign-01-IPC 2022-068
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: November 1, 2027

Study information

• Verified date: September 2023
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, Dr
• Phone: 0491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Cancer Of Pancreas
• Pancreatic Neoplasms

Intervention

Other:
• Analyze of GemCore status
Genomic analyze of GemCore status

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival of GemCore- patients	Overall survival of GemCore- patients	24 months
Primary	Percentage of alive GemCore+ patients treated with Gemcitabine	Percentage of alive GemCore+ patients treated with Gemcitabine	12 months
Secondary	Overall survival	Overall survival	24 months
Secondary	Tumor response rate	Tumor response rate	24 months
Secondary	Progression-free survival	Progression-free survival	24 months