Cancer Of PancreasGemSign-01NCT06046794
Efficacy of First-Line Gemcitabine Chemotherapy in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients
A study testing Analyze of GemCore status in people with Cancer Of Pancreas, run by Institut Paoli-Calmettes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Of Pancreas
- What is being tested?
- Analyze of GemCore status
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2024to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- Age ≥ 18 years;
- Patient not opposed to study participation;
- Affiliation to a social security system, or beneficiary of such a scheme.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Paoli Calmettes
Marseille
Jihane PAKRADOUNI, Dr, 0033491223778, drci.up@ipc.unicancer.fr
About this study
Official title: Phase IV Study Assessing Efficacy of First-Line Chemotherapy With Gemcitabine in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients Ineligible to FOLFIRINOX Treatment
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
- Being tested
- Analyze of GemCore status
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analyze of GemCore statusOther
Genomic analyze of GemCore status
| Study group | Role | What they receive |
|---|---|---|
| metastatic pancreatic adenocarcinoma patients | Experimental | Analyze of GemCore status Receives: Other: Analyze of GemCore status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of alive GemCore+ patients treated with Gemcitabine
Percentage of alive GemCore+ patients treated with Gemcitabine
Measured: 12 months
Secondary outcomes (3)
Overall survival
Overall survival
Measured: 24 months
Tumor response rate
Tumor response rate
Measured: 24 months
Progression-free survival
Progression-free survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start23 May 2024
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Of PancreasStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046794
- Sponsor's protocol ID
- GemSign-01-IPC 2022-068
- Acronym
- GemSign-01
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study Assessing Efficacy of First-Line Chemotherapy With Gemcitabine in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients Ineligible to FOLFIRINOX Treatment
- ClinicalTrials.gov ID
- NCT06046794
- Acronym / sponsor ID
- GemSign-01 / GemSign-01-IPC 2022-068
- Conditions
- Cancer Of Pancreas
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metastatic pancreatic adenocarcinoma patients | Experimental | Other: Analyze of GemCore statusAnalyze of GemCore status |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analyze of GemCore statusGenomic analyze of GemCore status | Other | metastatic pancreatic adenocarcinoma patients |
Primary outcome
Percentage of alive GemCore+ patients treated with Gemcitabine
Time frame: 12 months
Percentage of alive GemCore+ patients treated with Gemcitabine
3 secondary outcomes
Overall survival
Time frame: 24 months
Tumor response rate
Time frame: 24 months
Progression-free survival
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analyze of GemCore status in people with Cancer Of Pancreas, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jihane PAKRADOUNI, Dr (0491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of alive GemCore+ patients treated with Gemcitabine (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.