An interventional study of mFOLFIRINOX (modified FOLFIRINOX) in Pancreas Adenocarcinoma (MSI-H) and Pancreatic Cancer Resectable, sponsored by Institut Paoli-Calmettes. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Institut Paoli-Calmettes · Not applicable, Interventional, and Treatment
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Among 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes — 7 open to participants now, 8 under way, none of them phase 3. Pancreatic Neoplasms · Institut Paoli-Calmettes.
Among the 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes, this one has the largest planned enrollment of the 12 interventional ones that give a count, is the only one that started in 2026, is one of 9 with no phase, and was the 18th registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,005 are open to participants now.
Browse Pancreatic Neoplasms studies →7 of the 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes are open now, in 1 country. Recruiting first, the newest first:
Institut Paoli-Calmettes · Sites in France
Ages 18+
Institut Paoli-Calmettes · Sites in France
Ages 40–85
Institut Paoli-Calmettes · Sites in France
Ages 18+
Institut Paoli-Calmettes · Sites in France
Ages 18+
Institut Paoli-Calmettes · Sites in France
Ages 18+
By country, each count listing its studies:
Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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19 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 367 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Median enrollment 75 across the 12 interventional studies, 310 across the 7 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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Institut Paoli-Calmettes is the lead sponsor of 172 studies on the registry; 50 are open to participants now.
1 of the studies in Pancreatic Neoplasms by Institut Paoli-Calmettes that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05143970Institut Paoli-CalmettesA Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors | 2027-03 |
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Among the 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Pancreatic cancer exhibits significant heterogeneity, which poses a major challenge in selecting the best treatment for patients from the very beginning of care. Modern oncology recognizes the use of companion biomarkers to guide targeted therapy or immune checkpoint inhibitors. However, with regard to chemotherapy-which has long been the cornerstone of cancer treatment and remains crucial for most cancers-few predictive tests are available to guide the choice between monotherapy and combination chemotherapy.
Patients included in the PRODIGE 104 B - NEOPREDICT study will be those for whom the GEM transcriptomic signature is negative. This population will be treated according to the standard strategy and will be followed clinically and biologically to describe and identify the characteristics specific to this subgroup, and to compare the usual prognostic factors of this population with those of the GEM-positive population included in the parallel PRODIGE 104 A - NEOPREDICT study
Transcriptomic Signature for Patient Stratification and Prediction of Chemotherapy Sensitivity Transcriptomic signatures, derived from RNA-sequencing, capture unique patterns of gene expression that reflect the molecular phenotype of a tumor and can indicate its potential sensitivity or resistance to chemotherapeutic agents. Over the past decade, several molecular classifications of PDAC have been established (Collisson, Moffitt, Bailey), consistently distinguishing two major tumor subtypes: basal-like (poor prognosis) and classical (better prognosis). While these classifications provide strong prognostic information, they have not reliably predicted chemotherapy response in clinical practice.
Recent advances from the Dusetti/Iovanna research group have led to the development of robust transcriptomic signatures capable of predicting sensitivity to gemcitabine, irinotecan, 5-FU, oxaliplatin, and paclitaxel. These signatures-collectively referred to as Pancreas-View-were generated using preclinical models (PDX, organoids, primary cultures) and have been clinically validated, notably the gemcitabine-sensitivity signature in two retrospective cohorts and in the prospective PRODIGE 24 trial. Importantly, these signatures can be performed on FFPE-derived RNA with minimal material and rapid turnaround, making them compatible with real-world decision-making in the neoadjuvant setting.
Position of the Study Within Current Knowledge Pancreatic ductal adenocarcinoma (PDAC) remains a highly lethal disease due to late diagnosis, limited actionable biomarkers, and the modest efficacy of targeted and immunotherapeutic approaches. Its incidence is rising in Western countries, and without improved strategies, PDAC is projected to become the second leading cause of cancer-related death by 2040.
Borderline-resectable PDAC accounts for approximately 20% of cases and typically requires complex multidisciplinary management. Neoadjuvant chemotherapy (NAC)-now an international standard in BR-PDAC-offers several advantages: improved R0 resection rates, treatment of occult micrometastatic disease, and avoidance of futile surgery in rapidly progressing tumors.
Two main NAC regimens are currently used: mFOLFIRINOX and Gemcitabine + Nab-Paclitaxel. However, comparative studies in non-metastatic PDAC have not demonstrated a clear superiority of one regimen over the other, though their toxicity profiles differ substantially. As a result, selecting the optimal chemotherapy strategy remains challenging.
There is therefore a strong need for predictive biomarkers capable of guiding neoadjuvant regimen selection. The NEOPREDICT program positions itself directly within this unmet clinical need, evaluating the use of a transcriptomic gemcitabine-sensitivity signature to personalize treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients GEM- with BR-PDAC receiving standard mFOLFIRINOX according to clinical guidelines.
Drug: mFOLFIRINOX (modified FOLFIRINOX)
Patients with borderline resectable pancreatic ductal adenocarcinoma (BR-PDAC) who are negative for the gemcitabine sensitivity transcriptomic signature (GEM-) receive neoadjuvant mFOLFIRINOX chemotherapy as standard of care. This observational cohort follows patients prospectively without modifying routine management.
Primary Outcome Measure
Event-Free Survival is defined as the time from the start of treatment to the occurrence of any of the following events: * disease progression, * failure to undergo pancreatic resection, * death from any cause, * grade IV febrile neutropenia or grade IV diarrhea occurring during neoadjuvant chemotherapy. Participants without an event will be censored at the date of last follow-up.
Time frame: From treatment initiation through 1 year
Objective Response Rate (ORR)
Percentage of participants achieving a complete response or partial response per RECIST 1.1 criteria.
Time frame: During neoadjuvant chemotherapy (up to 16 weeks)
Overall Survival (OS)
Time from start of treatment to death from any cause.
Time frame: From treatment initiation through study completion (up to 18 months)
Progression-Free Survival (PFS)
For non-operated patients: time from treatment initiation to disease progression or death from any cause.
Time frame: From treatment initiation through study completion (up to 18 months)
Recurrence-Free Survival (RFS)
For operated patients: time from treatment initiation to first local or metastatic recurrence or death.
Time frame: From treatment initiation through study completion (up to 18 months)
Disease Control Rate (DCR)
Percentage of patients achieving complete response, partial response, or stable disease.
Time frame: During neoadjuvant chemotherapy (up to 16 weeks)
Tumor Regression Grade (TRG)
Pathologic tumor response assessed using Ryan's simplified Tumor Regression Grade (TRG 1-3) on the resected primary tumor.
Time frame: At time of surgery
Postoperative Complications (Clavien-Dindo Classification)
Postoperative complications graded from I to V according to Clavien-Dindo.
Time frame: Within 60 days after surgery
Time to Recurrence (TTR)
Time from treatment initiation to first recurrence (local or metastatic) or death related to cancer.
Time frame: Up to 18 months
Quality of Life (EORTC QLQ-C30 )
Change over time in the Global Health Status/Quality of Life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
Time frame: From baseline through study completion (up to 18 months)
Completion Rate of Neoadjuvant Chemotherapy (NAC)
Percentage of participants who completed all 8 cycles of mFOLFIRINOX (regardless of dose modifications).
Time frame: End of the 4-month NAC period
Adverse Events and Toxicities (NCI-CTCAE v5.0)
Incidence and severity of treatment-related toxicities graded according to NCI-CTCAE v5.0.
Time frame: Before each chemotherapy cycle (Weeks 0-16)
ime to First Deterioration in Global Health Status
Time to first deterioration of more than 5 points from baseline in the EORTC QLQ-C30 global health status score.
Time frame: From treatment initiation through study completion (up to 18 months)
Pancreatic Cancer-Specific Quality of Life (EORTC QLQ-PAN26)
Change over time in symptom and functional scores assessed using the EORTC QLQ-PAN26 pancreatic
Time frame: From baseline through study completion (up to 18 months)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for May 2030, 48 months later.
Of 403 non-industry interventional studies with no phase under Pancreatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 75. This study's planned 48 months is close to that.
Counting every sponsor, half of 430 studies reached it within 44 months; a quarter within 26 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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