ClinicalTrials.gg
RecruitingNCT06046794GemSign-01Updated Sep 29, 2026

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

An interventional study of Analyze of GemCore status in Cancer Of Pancreas, sponsored by Institut Paoli-Calmettes. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Institut Paoli-Calmettes · Not applicable, Interventional, and Other

From the registry’s dates

  • Started May 2024; still recruiting 2 years 5 months later.
Updated Sep 29, 2026Primary completion movedStudy completion movedGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes — 7 open to participants now, 8 under way, none of them phase 3. Pancreatic Neoplasms · Institut Paoli-Calmettes.

Planned enrollment
6th of 12
100 · median 75
Started
2024
the only one that year
No phase
9 of 19
4 open now
Registered
17th of 19
by date

Among the 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes, this one is the 6th largest by planned enrollment of the 12 interventional ones that give a count, is the only one that started in 2024, is one of 9 with no phase, and was the 17th registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,005 are open to participants now.

Browse Pancreatic Neoplasms studies →

Open to participants now

7 of the 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Cancer Of Pancreas
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pancreatic adenocarcinoma histological proved
  • FOLFIRINOX chemotherapy-ineligible patient and going to receive metastatic chemotherapy with gemcitabine monotherapy
  • Tumor material allowing assessment of GEMCore status (i.e. FFPE block with tumor cellularity ≥ 10%);
  • > 2 months;
  • Measurable target according to 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

Exclusion Criteria:

  • to Gemcitabine treatment;
  • 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    metastatic pancreatic adenocarcinoma patients

    Analyze of GemCore status

    Other: Analyze of GemCore status

Interventions

  • OtherAnalyze of GemCore status

    Genomic analyze of GemCore status

06

What researchers measure

Primary outcomes

  1. Percentage of alive GemCore+ patients treated with Gemcitabine

    Percentage of alive GemCore+ patients treated with Gemcitabine

    Time frame: 12 months

Secondary outcomes

  1. Overall survival

    Overall survival

    Time frame: 24 months

  2. Tumor response rate

    Tumor response rate

    Time frame: 24 months

  3. Progression-free survival

    Progression-free survival

    Time frame: 24 months

Other outcomes

  1. Overall survival of GemCore- patients

    Overall survival of GemCore- patients

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Nov 2029, 66 months after the start.

Of 403 non-industry interventional studies with no phase under Pancreatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 75. This study's planned 66 months is above that.

Counting every sponsor, half of 430 studies reached it within 44 months; a quarter within 26 and three quarters within 75.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 29, 2026: primary completion Nov 2027 → Nov 2029 and completion Nov 2027 → Nov 2029.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2023
First posted
Sep 21, 2023
StartActual
May 23, 2024
Primary completionEst.
Nov 2029was Nov 2027
CompletionEst.
Nov 2029was Nov 2027
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Nov 1, 2027→Nov 2029
Sep 29, 2026
Study completion
Nov 1, 2027→Nov 2029
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Primary completion Nov 1, 2027→Nov 2029
    Study completion Nov 1, 2027→Nov 2029
    + 3 other changes: verification date, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06046794
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
May 23, 2024
Primary completion
Nov 2029 (estimated)
Completion
Nov 2029 (estimated)
Last update
Sep 29, 2026

Study contacts

Jihane PAKRADOUNI, Dr
Contact
drci.up@ipc.unicancer.fr
0491223778

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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