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Carcinoma, Pancreatic DuctalPACsignNCT05475366

Personalized First-line Chemotherapy Choice in Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures

A study testing Clinical value of 5 transcriptomic signatures to personalize the therapeutic decision for L1 in PDAC and Biomarkers of tumor signatures (translational studies) in people with Carcinoma, Pancreatic Ductal and Prognosis, run by Institut Curie at 7 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of this study is to assess the clinical value of 5 transcriptomic signatures prognostic of chemotherapeutic sensitivity to improve the Objective Response Rate (ORR) of first-line (L1). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carcinoma, Pancreatic Ductal, Prognosis
What is being tested?
Clinical value of 5 transcriptomic signatures to personalize the therapeutic decision for L1 in PDAC and Biomarkers of tumor signatures (translational studies)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
7 sitesFrance
Study dates
12 Dec 2022to 11 Dec 2028
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
  • Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Histologically or cytologically proven Pancreatic Ductal Adenocarcinoma (PDAC).
  • Metastatic disease.
  • Measurable or evaluable lesions according to RECIST v1.1 criteria.
  • First-line therapy (previous neoadjuvant/adjuvant chemotherapy not allowed).
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  • Age ≥ 18 years (no upper limit, patients ≥ 75 years old must have a G8 score ≥ 14).
  • 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
  • Availability of tumor tissue sample from the primary pancreatic tumor or liver metastasis (chemo-naïve) before inclusion in step 1.
  • Adequate organ function, as defined by the following (blood test ≤ 7 days prior to inclusion):
  • Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) (≤ 5 ULN in case of liver metastases)
  • Total serum bilirubin ≤ 1.5 ULN
  • Serum albumin ≥ 28 g/L
  • Hemoglobin ≥ 9.0 g/dl
  • Absolute neutrophil count (ANC) ≥ 1,500/μL
  • Platelets ≥ 100,000/μL
  • Creatinine clearance ≥ 50 mL/min (MDRD).
  • No Dihydropyrimidine dehydrogenase (DPD) deficiency (normal uracil level).
  • Life expectancy ≥ 3 months.
  • a. Evidence of post-menopausal status b. (or) negative urinary or serum pregnancy test for female pre-menopausal patients.
  • Registration in a National Health Care System.

Who cannot join

  • Concurrent enrolment in another interventional clinical study.
  • Previous treatment with chemotherapy for pancreatic cancer.
  • Uncontrolled massive pleural effusion or massive ascites.
  • Known deficiency in UGT1A1 (homozygous UGT1A1*28 allele).
  • Active bacterial, viral, or fungal infection requiring systemic therapy, including tuberculosis, hepatitis B (known positive Hepatitis B Virus surface antigen (HBsAg) result), hepatitis C (with positive RNA), Sars-Cov-2 or human immunodeficiency virus (positive HIV 1/2 antibodies).
  • Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri.
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  • Known active central nervous system metastases and/or carcinomatous meningitis; patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline).
  • Uncontrolled intercurrent illness, including but not limited to, symptomatic congestive heart failure or coronary disease, peripheral artery disease, severe chronic obstructive pulmonary disease, decompensated cirrhosis, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  • Live vaccine administration within 30 days prior to the first dose of study treatment.
  • Known or suspected allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the participant, in the opinion of the treating investigator.
  • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
  • Major surgical procedure (as defined by the Investigator) within 4 weeks prior to the first dose of trial treatment.
  • Pregnancy/lactation.
  • Person under legal protection or tutelage or guardianship.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites

  • Hôpital Beaujon

    Clichy, 92210

  • Hôpital HENRI MONDOR

    Créteil, 94010

  • Hôpital Claude Hurriez

    Lille, 59037

  • Institut Paoli-Calmettes

    Marseille, 13573

  • CHU Robert Debré

    Reims, 51092

  • Institut Curie

    Saint-Cloud, 92210

  • Hôpital PAUL BROUSSE 12 Avenue Paul Vaillant Couturier

    Villejuif, 94800

Other trials in France

About this study

Official title: Pilot Study of Personalized First-line Chemotherapy Choice for Patients With Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures (PACsign)

The aim of this study is to assess the clinical value of 5 transcriptomic signatures prognostic of chemotherapeutic sensitivity to improve the Objective Response Rate (ORR) of first-line (L1). Chemotherapy regimen (FOLFIRINOX vs Gem-nabP) will be selected based on transcriptomic signatures applied to the pre-therapeutic liver biopsy of newly diagnosed PDAC patients.

Read the detailed description

Step 1: patients will sign a 1st informed consent prospectively for the molecular screening (RNAseq profile). 5 transcriptomic signatures will be applied for prediction of response to 5 Fluoro-Uracil (5FU), oxaliplatin, irinotecan, gemcitabine and taxane. Biomarker status will be obtained for all patients as part of good clinical practice.

Patients will be eligible for prospective step 2 only if the transcriptomic analysis is informative and the treatment can be started within 28 days.

Step 2: study treatment strategy: based on the results of transcriptomic signatures, patients will receive either FOLFIRINOX or Gem-nabP according to the following algorithm (2nd informed consent):

  • Predicted to be FOLFIRINOX sensitive (regardless of sensitivity to Gem-nabP) = FOLFIRINOX
  • Predicted to be FOLFIRINOX and Gem-nabP resistant = FOLFIRINOX
  • Presence of a germline breast cancer (BRCA) mutation (regardless of transcriptomic signature) = FOLFIRINOX (tumors sensitive to platinum).
  • Predicted to be Gem-nabP sensitive and FOLFIRINOX resistant = Gem-nabP

Chemotherapy with FOLFIRINOX and Gemcitabine plus nab-paclitaxel will be administered as in routine practice, according to their approval. Dose adaptation will be allowed according to investigator's usual practice.

Being tested
Clinical value of 5 transcriptomic signatures to personalize the therapeutic decision for L1 in PDAC, Biomarkers of tumor signatures (translational studies)
Keywords
Transcriptomic signatures, Personalized first-line chemotherapy, Metastatic PDAC
Medical subject headings
Carcinoma, Pancreatic Ductal, Anophthalmia with pulmonary hypoplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical value of 5 transcriptomic signatures to personalize the therapeutic decision for L1 in PDACOther

    Formalin-Fixed Paraffin-Embedded (FFPE) samples will be centralized in which nucleic acids extraction (DNA+RNA) and FFPE-compatible RNA-sequencing will be performed in real-time (≤28 days). RNAseq reads will be processed and all 5 transcriptomic signatures will be applied for prediction of response to 5FU, oxaliplatin, irinotecan, gemcitabine and taxane. In addition, biomarkers status will be obtained for all patients as part of good clinical practice.

  • Biomarkers of tumor signatures (translational studies)Other

    Blood (serum and plasma) will be drawn at baseline, week 8, and tumor progression in order to look for surrogate biomarkers of tumor signatures in liquid biopsy

Study groups in NCT05475366
Study groupRoleWhat they receive
Molecular screening for prediction of responseExperimentalL1 chemotherapy regimen (FOLFIRINOX vs Gemcitabine plus nab-paclitaxel (GemnabP)) will be selected based on transcriptomic signatures applied to the pre-therapeutic biopsy of newly diagnosed PDAC patients.
Receives: Other: Clinical value of 5 transcriptomic signatures to personalize the therapeutic decision for L1 in PDAC; Other: Biomarkers of tumor signatures (translational studies)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) at 4 months based on thorax-abdomen-pelvis (TAP) CT scan every 8 weeks according to RECIST v1.1.

    ORR, defined as the percentage of patients whose disease decreased by at least 30% (partial response - PR) and/or disappeared (complete response - CR) under treatment among patients who start treatment.

    Measured: 4 months

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    PFS, defined as the time from the date of treatment initiation to the date of progression or death whatever the cause. Progression will be assessed by the investigator based on TAP-CT scan every 8 weeks according to RECIST v1.1.

    Measured: 18 months

  2. Overall Survival (OS)

    OS, defined from the date of treatment initiation to the date of death whatever the cause.

    Measured: 18 months

  3. Disease Control Rate (DCR)

    DCR, defined as the percentage of patients who have achieved complete response, partial response or stable disease according to RECIST v1.1 among patients who start treatment.

    Measured: 18 months

  4. Treatment-related severe (grade 3-5) toxicities

    Toxicities will be graded, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (digestive, hematologic, neuropathy).

    Measured: 18 months

  5. Feasibility of study procedure

    Measured as the rate of usable samples

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start12 Dec 2022
  3. Primary completion11 Dec 2028 (estimated)
  4. Study completion11 Dec 2028 (estimated)

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05475366
Sponsor's protocol ID
IC 2021-15
Acronym
PACsign
Status last verified
Sep 2026
First submitted
7 Jul 2022
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Questions about this trial

What is this clinical trial studying?

A study testing Clinical value of 5 transcriptomic signatures to personalize the therapeutic decision for L1 in PDAC and Biomarkers of tumor signatures (translational studies) in people with Carcinoma, Pancreatic Ductal and Prognosis, run by Institut Curie at 7 sites 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 21 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) at 4 months based on thorax-abdomen-pelvis (TAP) CT scan every 8 weeks according to RECIST v1.1. (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05475366.

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 1 Oct 2026.

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