Personalize (Signature Driven) Neoadjuvant Chemotherapy Trial for Patients With Resectable Borderline Pancreatic Ductal Adenocarcinoma.

NCT07616362 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: PRODIGE 104 A (FFCD 2307)2024-519753-11-00
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 5

Brief Summary

Pancreatic ductal adenocarcinoma (PDAC) exhibits significant heterogeneity, making the optimal choice of chemotherapy challenging. While targeted therapies benefit from companion biomarkers, few tools exist to guide the selection of cytotoxic chemotherapy. Transcriptomic signatures now allow for the prediction of sensitivity to cytotoxic agents. Several molecular classifications (such as basal-like, classical, etc.) have been established and correlated with prognosis, but they are rarely used in clinical practice. The PaCaOmics program has developed robust predictive signatures, grouped under the name Pancreas-View Signature, capable of analyzing FFPE samples using minimal material. Locally advanced or borderline resectable pancreatic cancer (BR-PDAC) accounts for approximately 20% of cases. Neoadjuvant chemotherapy (NAC) has become the standard of care, improving R0 resection rates and overall survival. The two main chemotherapy regimens used are mFOLFIRINOX and GEM/NAB-paclitaxel, which show comparable efficacy and toxicity profiles. However, no clear consensus exists on the superiority of one over the other. Therefore, predictive biomarkers are crucial to help select the most appropriate neoadjuvant regimen, avoid unnecessary toxicities, and maximize the chances of curative surgery. The NEOPREDICT trial aims to evaluate the efficacy of treating patients with borderline resectable PDAC identified with a GEM+ sensitivity transcriptomic signature with GEMCITABINE + NAB-PACLITAXEL regimen compared to standard of care mFOLFIRINOX as NAC.

Conditions

Borderline Resectable Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Event Free Survival

  Event Free Survival (EFS) will be calculated from the date of randomization to the date at which the first event occurs. Patients alive without any event will be censored at the date of last news.Events to be considered for the endpoint will be: Disease progression, No pancreatic resection (all causes), Death whatever the cause, Grade IV febrile neutropenia or grade IV diarrhea during NAC.

  at 1 year after randomization

Secondary Outcomes (1)

• Objectif Response Rate (ORR)

  At 16 weeks after randomization

Study Arms (2)

NAB-PACLITAXEL - GEMCITABINE Arm

EXPERIMENTAL

NAB-PACLITAXEL 125 mg/m2 on day 1, 8 and 15 + GEMCITABINE 1000 mg/m2 on day 1, 8 and 15.

Drug: Nab paclitaxel / gemcitabine

mFOLFIRINOX Arm

ACTIVE COMPARATOR

Oxaliplatin 85 mg/m2 + Folinic acid 400 mg/m2 (or Leucovorin 200 mg/m²) + Irinotecan 180 mg/m2 (150 mg/m2 for older patient after SGA) + 5-FU 2400 mg/m2 as a continuous IV infusion over 46 hours

Drug: mFOLFIRINOX

Interventions

Nab paclitaxel / gemcitabine DRUG

NAB-PACLITAXEL 125 mg/m2 (30 min infusion) on day 1, 8 and 15. GEMCITABINE 1000 mg/m2 over 30 min infusion on day 1, 8 and 15.

NAB-PACLITAXEL - GEMCITABINE Arm

mFOLFIRINOX DRUG

Oxaliplatin 85 mg/m2 as a 2-hour IV infusion on day 1. Folinic acid 400 mg/m2 (or Leucovorin 200 mg/m²) as a 2-hour IV infusion (after end of oxaliplatin), in Y with irinotecan on day 1. Irinotecan 180 mg/m2 (150 mg/m2 for older patient after SGA) for 1h30 on day 1 (30 min after beginning of folinic acid). 5-FU 2400 mg/m2 as a continuous IV infusion over 46 hours, from day 1.

mFOLFIRINOX Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Borderline resectable pancreatic ductal adenocarcinoma (BR-PDAC) defined by National Comprehensive Cancer Network (NCCN) criteria v2.2025 on contrast-enhanced CT-scan (including non-contrast acquisition, pancreatic phase and portal venous phase), with stage confirmed by a local pancreatic expert review board including at least medical oncologist/onco-gastroenterologist, pancreatic surgeon and pancreatic expert radiologist. No central review is required,
• Measurable pancreatic lesion according to RECIST 1.1 (CT scan or MRI \< 28 days),
• WHO PS 1 or 0,
• Histologically proven pancreas ductal adenocarcinoma,
• Available FFPE from pancreatic tumor sample with \> 10% of tumor cells (assessed by a local expert pancreatic pathologist),
• No prior chemotherapy or radiation for pancreatic cancer (except one cycle of mFOLFIRINOX during waiting time for GEM + signature) or resection of pancreatic cancer,
• Age ≥18 years old and ≤ 80 years old if geriatric standardized evaluation validates the study chemotherapy regimen administration for patients between 75-80,
• Written informed consent obtained from patient before any protocol related intervention,
• Acceptation and ability to conform to the protocol requirement during all the duration of the investigation including treatment, scheduled visits, clinical and biological examinations and follow up,
• Adequate organ function, as defined by the following:
• AST and ALT \< 3.5 x upper limit of normal (ULN),
• Total serum bilirubin \< 3 x ULN, (for patients with total serum bilirubin between 1.5 and 3 x ULN, the dose of irinotecan will be adjusted in accordance with the SmPC).
• Serum albumin \>30 g/L,
• Hemoglobin \>9.0 g/dl,
• Absolute neutrophil count (ANC) \>1.5 G/L,

You may not qualify if:

• Strictly resectable or locally advanced PDAC according to NCCN criteria,
• Distant metastases (including inter aortic lymph nodes),
• Any condition that contraindicates the use of IRINOTECAN, OXALIPLATIN, 5FU, GEMCITABINE or NAB-PACLITAXEL,
• Partial or complete DPD deficiency (uracilemia ≥ 16 ng/mL),
• Any progressive pathology not stabilized over the past 6 months: liver impairment, renal impairment, respiratory or cardiac failure.
• Other concomitant cancer or a history of cancer during the previous 3 years, except for localized cancer in situ, basal or squamous cell skin cancer adequately treated,
• Other interventional clinical trial except for non-interventional trial (ie not modifying 1-year EFS),
• QT/QTc (Fredericia Correction) interval \> 450 msec for men and \> 460 msec for women,
• Pregnant or breastfeeding woman,
• Known Gilbert's syndrome or known homozygosity for UGAT1A1\*28 polymorphism,
• Treatment with millepertuis,
• Uncompensated asthma,
• Potentially severe infection \< 7 days,
• Inflammatory bowel disease and/or intestinal obstruction,
• Known severe allergy to contrast dye (for CT or MRI) without possible substitution,

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Study Sites (5)

Hôpital Beaujon

Clichy, France

Location

Institut Paoli Calmettes

Marseille, France

Location

Hôpital Lyon Sud

Pierre-Bénite, France

Location

Hopital Nord Chu Saint Etienne

Saint-Priest-en-Jarez, France

Location

Hôpital Rangueil

Toulouse, France

Location

MeSH Terms

Interventions

Taxes; Gemcitabine

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Falilatou SAKA

CONTACT

0658636325; prodige104.neopredict@ffcd.fr

Study Design

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

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2031
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

FR (5)