ClinicalTrials.gg
Not yet recruitingNCT07808567POWERUpdated Sep 15, 2026

Evaluation of the Efficacy and Safety of Neoadjuvant Therapy in Patients With Surgically Resectable Pancreatic Adenocarcinoma.

A Phase 2 interventional study of GnP and FOLFIRINOX in Pancreatic Adenocarcinoma Resectable, Non Metastatic and ECOG Performance Status Score of 0 or 1, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is an open master platform trial, which includes multi neo-adjuvant treatment trials, multi-center, national. This platform trial evaluates the major pathological response rate (mPR) after surgery.

Intervention: The procedure consists of administering a neoadjuvant treatment and then performing pancreatic surgery. The POWER platform trial aims to study several neoadjuvant treatments prior to surgery. They will be described in each sub-study, in appendix. The surgery will be performed on one day and the end of the treatment is the safety visit post-surgery (90 days after surgery).

02

Conditions studied

  • Pancreatic Adenocarcinoma Resectable
  • Non Metastatic
  • ECOG Performance Status Score of 0 or 1
03

In context

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 245 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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

  • Adult, age ≥ 18 years old at the time of signing the form.
  • Documented informed consent.
  • or cytologically confirmed pancreatic adenocarcinoma.
  • Tumor deemed resectable based on local assessment.
  • No evidence of distant on CT scan or PET scan, as well as liver MRI prior to registration.
  • (Eastern Cooperative Oncology Group) performance status of 0 or 1.
  • Adequate hematologic and organ function, defined by the following laboratory results obtained within 7 days prior to initiation of study treatment:

    1. Neutrophils ≥ 1.5 × 10⁹/L (≥ 1500/µL) without granulocyte colony-stimulating factor support.
    2. count ≥ 100 × 10⁹/L (≥ 100,000/µL) without transfusion.
    3. ≥ 90 g/L (≥ 9 g/dL). Patients may be transfused to meet this criterion.
    4. , ALT, and ALP ≤ 3 × (ULN).
    5. Total ≤ 1.5 × ULN. ≥ 50 mL/min (calculated using the formula).
    6. Albumin ≥ 30 g/L (≥ 2.5 g/dL).
    7. For patients not receiving anticoagulant therapy: and aPTT ≤ 1.5 × ULN.
  • Women of (WOCBP) must have a negative urine or serum β-HCG pregnancy test within 7 days prior to the registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required at 72-24 hours before starting the treatment. Sexually active female patients must agree to use two methods of effective (cf. paragraph 7.10, one of them being a barrier method, or to abstain from sexual activity during the clinical investigation and for at least 6 months after last dose neoadjuvant treatment.
  • Sexually active males patients must agree to use condom during the clinical investigation and for at least 6 months after the neo-adjuvant treatment. Also, it is recommended the childbearing potential female partner uses a highly effective method of contraception for the same duration (see paragraph 6.12 " Pregnancy and contraception ").
  • Patients shall be eligible to undergo neo adjuvant treatment, surgery and tumor .
  • Patients must be affiliated to a social security system or beneficiary of the same.
  • Additional specific sub-study inclusion criteria: Patient should also meet the potential specific eligibility criteria of the sub-study for which they are screened.

Exclusion criteria

Exclusion Criteria:

  • Ongoing participation in clinical sub-study involving the use of an product prior to registration in the sub-study.
  • During participation in this study, patients will not receive any other clinical investigational drugs or any other anti-tumor drugs as describes on sub-study.
  • Previous or induction treatment for pancreatic cancer, including cytotoxic chemotherapy, immunotherapy, experimental therapy, or radiotherapy.
  • Uncontrolled tumor-related pain.
  • Pregnancy or breastfeeding Pregnant or breastfeeding women or intending to become pregnant during the study.
  • Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
  • No prior treatment including surgery, radiation therapy or systemic therapy for pancreatic adenocarcinoma.
  • Patients with a history of another primary diagnosed or requiring treatment within the 2 years prior to the first administration of the study drug. The following prior malignancies are not considered exclusion criteria, provided they have been treated with curative intent: completely resected basal cell carcinoma or squamous cell carcinoma of the skin; localized prostate cancer; superficial or non-invasive bladder cancer; or carcinoma in situ of any site.

This should be discussed with the oncologist if necessary.

  • Additional specific sub-study exclusion criteria: Patient should also meet the specific eligibility criteria of the sub-study for which they are screened.
Terms in these criteria, in plain language(18)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

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

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.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumor. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    POWER A - Folfirinox

    POWER A is an open label phase II, national multicenter, sub-study. POWER A evaluates the major pathological response rate (mPR) after surgery. The procedure consists of administering the neoadjuvant treatment: Folfirinox. Eligible patients will be registrated in POWER A assigned to receive neo adjuvant treatment for 28 days, with 2 infusions of Folfirinox administered every 14 days. The pancreatic surgery will be performed at the end of the neo adjuvant treatment.

    Drug: FOLFIRINOX

  • Experimental
    POWER B - GnP

    POWER B is an open label phase II, national multicenter, sub-study. POWER B evaluates the major pathological response rate (mPR) after surgery. Intervention: The procedure consists of administering the neoadjuvant treatment: Gemcitabine \& Nab-Paclitaxel. Eligible patients will be registrated in POWER B assigned to receive neo adjuvant treatment for 28 days, with one cycle of 28 days of Gemcitabine \& Nab-Paclitaxel (GnP) administered. The pancreatic surgery will be performed at the end of the neo adjuvant treatment.

    Drug: GnP

Interventions

06

What researchers measure

Primary outcomes

  1. Major pathological response rate (mPR) on surgical resection specimen

    The efficacy of various experimental drugs, based on pathological response, when administered in a preoperative setting will be analyzed. The major pathological response rate (mPR) will be evaluated on the surgical resection specimen

    Time frame: After pancreatic surgical resection, after 28 days of treatment

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Jan 2029, 24 months later.

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

Registered
Sep 2, 2026
First posted
Sep 9, 2026
StartEst.
Jan 2027
Primary completionEst.
Jan 2029
CompletionEst.
Jan 2032
Last update
Sep 15, 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.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07808567
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jan 2029 (estimated)
Completion
Jan 2032 (estimated)
Last update
Sep 15, 2026

Study contacts

Antoine HOLLEBECQUE
Contact
Antoine.hollebecque@gustaveroussy.fr
+33142114355
Clementine MAHAUT
Contact
clementine.mahaut@gustaveroussy.fr
+33142112334

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Gemcitabine · Albumin-Bound Paclitaxel · Folfirinox

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