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

NCT07808567 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: 2026-527559-24-00CSET number
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Outcome Measures

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

  After pancreatic surgical resection, after 28 days of treatment

Study Arms (2)

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.

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.

Drug: GnP

Interventions

FOLFIRINOX DRUG

POWER A - Neo adjuvant treatment (Folfirinox) for 28 days

POWER A - Folfirinox

GnP DRUG

POWER B - Neo adjuvant treatment (GnP) for 28 days

Also known as: Gemcitabine, Nab-Paclitaxel

POWER B - GnP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• This should be discussed with the oncologist if necessary.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; folfirinox

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Antoine HOLLEBECQUE

CONTACT

+33142114355; Antoine.hollebecque@gustaveroussy.fr

Clementine MAHAUT

CONTACT

+33142112334; clementine.mahaut@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2032
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)