A Phase II, Plateform Study, Open-label, Evaluating the Efficacy and Safety of Neoadjuvant Treatment in Patients With Surgically Resecable Pancreatic Adenocarcinoma. (POWER)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Adenocarcinoma Resectable; ECOG Performance Status Score of 0 or 1; Non Metastatic
• Intervention / Treatment: Drug: FOLFIRINOX; Drug: GnP

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Antoine HOLLEBECQUE; Phone Number: +33142114355; Email: Antoine.hollebecque@gustaveroussy.fr
• Study Contact Backup: Name: Clementine MAHAUT; Phone Number: +33142112334; Email: clementine.mahaut@gustaveroussy.fr

Study Locations

• France
  • Villejuif, France, 94800
    • Gustave Roussy
    • Contact: Antoine HOLLEBECQUE; Phone Number: + 33 1 42 11 43 55; Email: Antoine.hollebecque@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

• 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. Platelet count ≥ 100 × 10⁹/L (≥ 100,000/µL) without transfusion.
  3. Hemoglobin ≥ 90 g/L (≥ 9 g/dL). Patients may be transfused to meet this criterion.
  4. AST, ALT, and ALP ≤ 3 × upper limit of normal (ULN).
  5. Total bilirubin ≤ 1.5 × ULN.Creatinine clearance ≥ 50 mL/min (calculated using the MDRD formula).
  6. Albumin ≥ 30 g/L (≥ 2.5 g/dL).
  7. 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; POWER A - Neo adjuvant treatment (Folfirinox) for 28 days
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; POWER B - Neo adjuvant treatment (GnP) for 28 days; Other Names: Gemcitabine; Nab-Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	After pancreatic surgical resection, after 28 days of treatment

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2032

Study Registration Dates

• First Submitted: September 2, 2026
• First Submitted That Met QC Criteria: September 2, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; 130-nm albumin-bound paclitaxel; folfirinox
• Other Study ID Numbers: 2026-527559-24-00; CSET number (Other Identifier: 2026 / 4395)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes