[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreas-adenocarcinoma-msi-h\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreas-adenocarcinoma-msi-h":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100637776","a-trial-using-transcriptomic-signatures-to-personalize-neoadjuvant-chemotherapy-nac-for-patients-with-resectable-borderline-pancreatic-adenocarcinoma-pdac-100637776",false,"NCT07592819","A Trial Using Transcriptomic Signatures to Personalize Neoadjuvant Chemotherapy (NAC) for Patients With Resectable Borderline Pancreatic Adenocarcinoma (PDAC)","A Multicenter Randomized Phase II Trial Using Transcriptomic Signatures to Personalize Neoadjuvant Chemotherapy (NAC) for Patients With Resectable Borderline Pancreatic Adenocarcinoma (PDAC)","PRODIGE 104 B","Inclusion Criteria:\n\n* Borderline-resectable pancreatic ductal adenocarcinoma (BR-PDAC) as defined by the National Comprehensive Cancer Network (NCCN) v2.2025 criteria, identified on contrast-enhanced CT scan and reviewed by a local multidisciplinary pancreatic expert board including at least a medical oncologist \u002F onco-gastroenterologist, a pancreatic surgeon, and an expert pancreatic radiologist. No central review required.\n* WHO Performance Status 0-1.\n* Histologically confirmed pancreatic ductal adenocarcinoma, including histological variants.\n* Patient included-but not randomized-in the PRODIGE 104 A NEOPREDICT study due to a negative gemcitabine sensitivity signature (GEM-).\n* Negative gemcitabine transcriptomic signature (test centrally performed in PRODIGE 104 A NEOPREDICT).\n* No prior chemotherapy or radiotherapy for pancreatic cancer, and no previous definitive pancreatic cancer resection (except one cycle of mFOLFIRINOX administered while awaiting the signature result).\n* Age \\> 18 years and \\\u003C 80 years, with the possibility to include patients aged 75-80 if a standardized geriatric assessment confirms eligibility for the study chemotherapy regimen.\n* Ability and willingness to comply with protocol requirements during the entire study period (treatment, scheduled visits, clinical and biological examinations, follow-up).\n* Patient's non-opposition to participation in the study.\n* Affiliation to the French national health insurance system.\n\nExclusion Criteria:\n\n* Strictly resectable or locally advanced PDAC according to NCCN criteria.\n* Distant metastases, including inter-aortocaval lymph nodes.\n* Any condition contraindicating the use of irinotecan, oxaliplatin, or 5-FU.\n* Complete dihydropyrimidine dehydrogenase (DPD) deficiency.\n* Any uncontrolled or unstable medical condition within the past 6 months (e.g., hepatic, renal, respiratory, or cardiac insufficiency).\n* Another concomitant malignancy or history of cancer within the past 3 years, except for adequately treated carcinoma in situ of the cervix or basal\u002Fsquamous cell skin carcinoma.\n* Pregnancy or breastfeeding.\n* Patients under legal protection, guardianship, curatorship, or under judicial\u002Fadministrative protection.\n* Patients receiving psychiatric care or unable to provide consent.\n* Inability to comply with medical follow-up for geographical, social, or psychological reasons.","ALL","18 Years","80 Years",{"count":21,"type":22},367,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.\n\nPatients 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",[28,29],"Pancreas Adenocarcinoma (MSI-H)","Pancreatic Cancer Resectable",[31,32,33],"Transcriptomic-guided chemotherapy","Borderline-resectable pancreatic cancer","Predictive biomarker validation","NOT_YET_RECRUITING","2026-05-11",{"date":37,"type":38},"2026-05-18","ACTUAL",{"date":40,"type":22},"2026-05",{"date":42,"type":22},"2031-11",{"name":44,"class":45},"Institut Paoli-Calmettes","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100614058","superb-microvascular-imaging-smi-and-two-dimensional-endoscopic-ultrasound-guided-shear-wave-elastography-2d-swe-eus-in-differential-diagnosis-of-pancreatic-adenocarcinoma-pa-from-other-pancreatic-solid-lesions-psls-and-pancreatic-neuroendocrine-tumors-pnets-malignancy-100614058","NCT07274657","Superb Microvascular Imaging (SMI) and Two-Dimensional Endoscopic Ultrasound Guided Shear Wave Elastography (2D-SWE-EUS) in Differential Diagnosis of Pancreatic Adenocarcinoma (PA) From Other Pancreatic Solid Lesions (PSLs) and Pancreatic neuroendocrinE Tumors (pNETs) Malignancy","SMILE","Inclusion Criteria:\n\n* Patient, male or female, age ≥ 18 years old\n* Patient with diagnosed pancreatic solid or mixed (cystic component ≤25 % of tumor volume) lesion\n* Patient with adequate understanding of written and spoken French, able to sign written informed consent\n* Patient affiliated with a social security system\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Patient with usual contraindications to EUS- TA\n* Patient with usual contraindications to SonoVue® administration\n* Patient with a genetic syndrome associated pancreatic lesion (multiple neuroendocrine neoplasia type 1 (MEN1), type 1 neurofibromatosis (NF), Von-Hippel Lindau (VHL) disease)\n* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.\n* Patient unable to perform the monitoring",{"count":54,"type":22},150,[25],"Pancreatic adenocarcinoma (PA) is the most common tumor of the pancreas. Given its poor prognosis and the major therapeutic consequences, the discrimination between PA and other pancreatic solid lesions is mandatory.\n\nEndoscopic ultrasound (EUS) is admitted as the most sensitive imaging procedure for the detection and characterization of pancreatic tumors. Over the past 30 years, EUS-guided tissue acquisition (EUS-TA), or more recently fine needle biopsy (EUS-FNB), has demonstrated its efficiency for tissue sampling and remains the gold standard for the pathologic diagnosis of pancreatic lesions.\n\nThe assessment of pancreatic tumor enhancement using ultrasound contrast agents (UCAs) in real time with imaging specific methods seems useful to improve their characterization either by contrast-enhanced EUS (CE-EUS) or, more recently, by contrast-harmonic EUS (CH-EUS). CH-EUS was already demonstrated useful to differentiate pancreatic adenocarcinoma from other pancreatic lesions.\n\nEUS-Elastography (EUS-E) is another EUS image enhancement technique, which rational based on the difference in elasticity between the tissues. There are two types of elastographies: strain elastography (SE) and shear wave elastography (SWE). SE has proved useful for the characterization of pancreatic lesions and lymph nodes. However, this technique was demonstrated difficult to perform with adequate accuracy and reproducibility for pancreatic lesions and have many limitations. In some recent publications SWE was demonstrated moderate reliability.\n\nPancreatic neuroendocrine tumors (pNETs) are rare tumors, but according to the last epidemiological data, their incidence and prevalence are steadily rising.\n\nSurgical resection is generally performed for pNETs due to their malignant potential. However, with increasing use of high-resolution conventional imaging, the significant incidence of small (≤ 2 cm) pancreatic neuroendocrine incidentaloma (pNET) has risen in recent decades.\n\nEUS is recognized as the most sensitive procedure for the detection and characterization of pNETs. Overall sensitivity of EUS-TA for the diagnosis of pNETs is high, reaching 95.1% in recently published study, appearing higher in small lesions (≤ 20 mm) than in large lesions (\\> 20 mm).\n\nThe overall concordance rate for EUS-TA and surgical specimens grading varies from 58% to 86.4% and is higher for lesions ≤ 10 mm, 10-20 mm, comparing to lesions \\> 20 mm. These results confirm the risk of under or over-grading of pNETs on the EUS-TA specimen, independently of the needle size which used for the TA.\n\nCH-EUS was also demonstrated accurate in the prediction of pNETs malignancy and useful for decision-making management of these tumors.\n\nHypothesis\n\nTwo new image enhancement EUS technologies were recently developed, able to assess precisely tumor microvascular density and the stiffness of pancreatic lesions, that is correlated to tumor's stroma fibrosis, and thus help to characterize and predict the malignancy, and accordingly, the management of the pancreatic solid lesions. It's particularly useful in overcoming EUS false-negative cases of PA and small pNETs malignancy diagnosis.\n\nSuperb Microvascular Imaging (SMI) is a novel doppler technique that enhances the range of visible blood flow, by revealing low velocity microvascular flow, enabling the capture of a higher-quality microvascular flow images. Based on the same principle as CH-EUS, which assesses tumor microvascularization, this technique is expected to be also useful for the PSLs malignancy diagnosis.\n\nShear Wave Elastography (SWE) relies on the properties of shear-wave propagation to offer an advanced assessment of their velocity",[28,58],"Pancreatic Neuroendocrine Tumors (pNET)","2025-12-09",{"date":61,"type":38},"2025-12-10",{"date":63,"type":22},"2026-01-01",{"date":65,"type":22},"2028-06-30",{"name":67,"class":45},"GCS Ramsay Santé pour l'Enseignement et la Recherche",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":82,"conditions":83,"keywords":120,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":163},"100445919","phase-1-a-beta-only-il-2-immunotherapy-study-100445919","NCT05086692","A Beta-only IL-2 ImmunoTherapY Study","A Phase 1\u002F2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors","ABILITY-1","Key Inclusion Criteria:\n\n1. Aged at least 18 years (inclusive at the time of informed consent).\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)\n5. Demonstrated adequate organ function\n6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and\u002For MRI.\n7. Life expectancy of ≥ 12 weeks.\n8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.\n9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.\n\nKey Exclusion Criteria:\n\n1. Last administration of prior antitumor therapy:\n\n   * Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.\n   * Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\\\u003C2 weeks of radiotherapy) to non-CNS disease.\n   * Radiation therapy to the lung that is \\> 30Gy within 6 months prior to start of treatment.\n   * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.\n2. Has known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.\n3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.\n4. Condition requiring long-term systemic treatment with either corticosteroids \\> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.\n5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.\n6. Severe pulmonary, cardiac or other systemic disease.\n7. Known hepatitis B or C virus infection.\n8. Females who are pregnant or lactating or planning to become pregnant during the study.\n9. Has had an allogeneic tissue\u002Fsolid organ transplant.\n10. Active infection requiring systemic therapy.\n11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol\n12. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.\n13. Known severe hypersensitivity to any component of study drug(s).\n14. Inability to comply with study and follow up procedures as judged by the Investigator.",{"count":78,"type":22},115,[80,81],"PHASE1","PHASE2","This is a Phase 1\u002F2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.",[84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,28,116,117,118,119],"Advanced Solid Tumor","Unresectable Solid Tumor","Clear Cell Renal Cell Carcinoma","Triple Negative Breast Cancer","Non-Small Cell Lung Cancer Squamous","Non-Small Cell Lung Cancer Non-squamous","Colorectal Cancer (MSI-H)","Gastric Cancer","Cervical Cancer","Basal Cell Carcinoma","Bladder Cancer","Merkel Cell Carcinoma","Squamous Cell Carcinoma of Head and Neck","Cutaneous Squamous Cell Carcinoma","Pleural Mesothelioma","Esophageal Cancer","Endometrial Carcinoma","Solid Tumor","Solid Tumor, Adult","MSI-H Solid Malignant Tumor","Cancer With A High Tumor Mutational Burden","Epithelial Ovarian Carcinoma","Primary Peritoneal Cancer","Gastroesophageal Junction (GEJ) Cancer","Acral Melanoma","Mucosal Melanoma","Cutaneous Melanoma","DMMR Solid Malignant Tumor","Fallopian Tube Cancer","Ovarian Cancer","MSI-H Cancer","DMMR Cancer","Skin Cancer","Viral Cancer","Cervical Cancers","Endometrial Cancer",[121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151],"IL-2","IL2","Interleukin-2","cancer","metastatic","ccRCC","TNBC","NSCLC","CRC","GEJ","intrahepatic","extrahepatic","MCC","SCCHN","CSCC","Gastroesophageal Junction","advanced","unresectable","MSI-H","dMMR","Microsatellite Instability-High","Mismatch Repair Deficient","PD-1","immunotherapy","anti-PD-1","BCC","RCC","HCC","Tumor Mutation Burden High","TMB-H","PDAC","RECRUITING","2025-07-03",{"date":155,"type":38},"2025-07-09",{"date":157,"type":38},"2021-08-27",{"date":159,"type":22},"2026-12-30",{"name":161,"class":162},"Medicenna Therapeutics, Inc.","INDUSTRY",27]