Pancreatic Adenocarcinoma ResectablePhase 2POWERNCT07808567
Evaluation of the Efficacy and Safety of Neoadjuvant Therapy in Patients With Surgically Resectable Pancreatic Adenocarcinoma.
A Phase 2 study testing GnP and FOLFIRINOX in people with Pancreatic Adenocarcinoma Resectable and Non Metastatic, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma Resectable, Non Metastatic, ECOG Performance Status Score of 0 or 1
- What is being tested?
- GnP and FOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2027to Jan 2032
- Phase
- Phase 2
- 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
- Adult, age ≥ 18 years old at the time of signing the informed consent form.
- Documented informed consent.
- Histologically or cytologically confirmed pancreatic adenocarcinoma.
- Tumor deemed resectable based on local assessment.
- No evidence of distant metastases on CT scan or PET scan, as well as liver MRI prior to registration.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
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- Adequate hematologic and organ function, defined by the following laboratory results obtained within 7 days prior to initiation of study treatment:
- Neutrophils ≥ 1.5 × 10⁹/L (≥ 1500/µL) without granulocyte colony-stimulating factor support.
- Platelet count ≥ 100 × 10⁹/L (≥ 100,000/µL) without transfusion.
- Hemoglobin ≥ 90 g/L (≥ 9 g/dL). Patients may be transfused to meet this criterion.
- AST, ALT, and ALP ≤ 3 × upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 × ULN.Creatinine clearance ≥ 50 mL/min (calculated using the MDRD formula).
- Albumin ≥ 30 g/L (≥ 2.5 g/dL).
- For patients not receiving anticoagulant therapy: INR and aPTT ≤ 1.5 × ULN.
- Women of childbearing potential (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 neo-adjuvant treatment. Sexually active female patients must agree to use two methods of effective contraception (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 biopsies.
- 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.
Who cannot join
- Ongoing participation in clinical sub-study involving the use of an investigational 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 neoadjuvant 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.
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- No prior treatment including surgery, radiation therapy or systemic therapy for pancreatic adenocarcinoma.
- Patients with a history of another primary malignancy 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.
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
Gustave Roussy
Villejuif, 94800
Antoine HOLLEBECQUE, + 33 1 42 11 43 55, Antoine.hollebecque@gustaveroussy.fr
About this study
Official title: A Phase II, Plateform Study, Open-label, Evaluating the Efficacy and Safety of Neoadjuvant Treatment in Patients With Surgically Resecable Pancreatic Adenocarcinoma
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).
- Conditions
- Pancreatic Adenocarcinoma Resectable, Non Metastatic, ECOG Performance Status Score of 0 or 1
- Being tested
- GnP, FOLFIRINOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnPDrug
Also called Gemcitabine, Nab-Paclitaxel
POWER B - Neo adjuvant treatment (GnP) for 28 days
FOLFIRINOXDrug
POWER A - Neo adjuvant treatment (Folfirinox) for 28 days
| Study group | Role | What they receive |
|---|---|---|
| POWER A - Folfirinox | Experimental | 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. Receives: Drug: FOLFIRINOX |
| POWER B - GnP | Experimental | 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. Receives: Drug: GnP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After pancreatic surgical resection, after 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Adenocarcinoma ResectableStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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. . The POWER platform trial aims to study several neoadjuvant treatments prior to surgery. They will be described in each sub-study.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808567
- Sponsor's protocol ID
- 2026-527559-24-00
- Other IDs
- CSET number
- Acronym
- POWER
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Plateform Study, Open-label, Evaluating the Efficacy and Safety of Neoadjuvant Treatment in Patients With Surgically Resecable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07808567
- Acronym / sponsor ID
- POWER / 2026-527559-24-00
- Conditions
- Pancreatic Adenocarcinoma Resectable, Non Metastatic, ECOG Performance Status Score of 0 or 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 9 Sep 2026 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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. . The POWER platform trial aims to study several neoadjuvant treatments prior to surgery. They will be described in each sub-study.
| Arm | Type | Receives |
|---|---|---|
| POWER A - Folfirinox | Experimental | Drug: FOLFIRINOXPOWER 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. |
| POWER B - GnP | Experimental | Drug: GnPPOWER 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Adult, age ≥ 18 years old at the time of signing the informed consent form.
- Documented informed consent.
- Histologically or cytologically confirmed pancreatic adenocarcinoma.
- Tumor deemed resectable based on local assessment.
- No evidence of distant metastases on CT scan or PET scan, as well as liver MRI prior to registration.
Key exclusion criteria (10 listed)
- Ongoing participation in clinical sub-study involving the use of an investigational 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 neoadjuvant 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.
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 |
|---|---|---|
| GnPAlso: Gemcitabine, Nab-PaclitaxelPOWER B - Neo adjuvant treatment (GnP) for 28 days | Drug | POWER B - GnP |
| FOLFIRINOXPOWER A - Neo adjuvant treatment (Folfirinox) for 28 days | Drug | POWER A - Folfirinox |
Primary outcome
Major pathological response rate (mPR) on surgical resection specimen
Time frame: After pancreatic surgical resection, after 28 days of treatment
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
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 15 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 Phase 2 study testing GnP and FOLFIRINOX in people with Pancreatic Adenocarcinoma Resectable and Non Metastatic, run by Gustave Roussy, Cancer Campus, Grand Paris 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 19 inclusion and 10 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: opening soon, as of the sponsor's last update on 15 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Antoine HOLLEBECQUE (+33142114355, Antoine.hollebecque@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response rate (mPR) on surgical resection specimen (time frame: After pancreatic surgical resection, after 28 days of treatment). 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 15 Sep 2026.