Borderline Resectable Pancreatic Ductal AdenocarcinomaPhase 2NEOPREDICTNCT07616362
Personalize (Signature Driven) Neoadjuvant Chemotherapy Trial for Patients With Resectable Borderline Pancreatic Ductal Adenocarcinoma.
A Phase 2 study testing Nab paclitaxel / gemcitabine and mFOLFIRINOX in people with Borderline Resectable Pancreatic Ductal Adenocarcinoma, run by Federation Francophone de Cancerologie Digestive at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Borderline Resectable Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Nab paclitaxel / gemcitabine and mFOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 5 sitesFrance
- Study dates
- Jun 2026to Apr 2031
- Phase
- Phase 2
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 20Show fewer
- 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,
- Platelets >100 G/L,
- Creatinine clearance > 50 mL/min (according to CKD-EPI),
- Normal Kalemia, calcemia, magnesemia
- Women of childbearing potential must agree to use contraception during treatment and for at least 15 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 12 months after discontinuation of the experimental treatments.
- Patient affiliated to French social security
Who cannot join
- 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,
Show all 22Show fewer
- 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,
- Hypersensitivity to the active substance or to one of the excipients of one of the study treatments,
- Treatment with brivudine within 4 weeks prior to the administration of protocol treatment,
- Concomitant treatment with a strong inhibitor (i.e. ketoconazole) or inducer (i.e. rifampicin, carbamazepine, phenobarbital, phenytoin, apalutamide) of cytochrome P450 3A4 or 2C8 (CYP3A4 or CYP2C8),
- Patient who has received a live attenuated vaccine (against yellow fever, chickenpox, shingles, measles, mumps, rubella, tuberculosis, rotavirus) in the 6 weeks prior to randomization,
- Patient with sensitive peripheral neuropathy with functional discomfort,
- Impossibility of undergoing medical monitoring during the trial for geographical, social, or psychological reasons,
- Patient who is under judicial protection (patient who is legally institutionalized or under guardianship or curatorship) or not able to give consent. (as refered at art. art. L. 1121-6, art. L. 1121-8, art. L. 1121-8-1 du Code de la Santé Publique)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites
Hôpital Beaujon
Clichy
Maher AKEZ, maher.akez-ext@aphp.fr
Louis De Mestier, MD
Institut Paoli Calmettes
Marseille
Christophe BOUVIER, BOUVIERC3@ipc.unicancer.fr
Brice CHANEZ, MD
Hôpital Lyon Sud
Pierre-Bénite
Maëlys SIEGWALD, maelys.siegwald@chu-lyon.fr
Marion CHAUVENET, MD
Hopital Nord Chu Saint Etienne
Saint-Priest-en-Jarez
Fabrice DI PALMA, PhD, fabrice.dipalma@chu-st-etienne.fr
Nicolas WILLIET, MD
Hôpital Rangueil
Toulouse
Caroline GREGOIRE, gregoire.c@chu-toulouse.fr
Nadim FARES, MD
About this study
Official title: a Multicenter Phase II Trial Using Transcriptomic Signatures to Personalize Neoadjuvant Chemotherapy for Patients With Resectable Borderline Pancreatic Ductal Adenocarcinoma.
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.
- Being tested
- Nab paclitaxel / gemcitabine, mFOLFIRINOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab paclitaxel / gemcitabineDrug
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.
mFOLFIRINOXDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: mFOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 1 year after randomization
Secondary outcomes (1)
Objectif Response Rate (ORR)
Objective Response rate (ORR) will be evaluated with RECIST 1.1 criteria by the investigator regarding the scans during the NAC. The objective response rate is defined as % of patients with a complete or a partial response.
Measured: At 16 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Resectable Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616362
- Sponsor's protocol ID
- PRODIGE 104 A (FFCD 2307)
- Other IDs
- 2024-519753-11-00
- Acronym
- NEOPREDICT
- Status last verified
- Jun 2026
- First submitted
- 11 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No