[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"resectable-pancreatic-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:resectable-pancreatic-adenocarcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,57,84,122,147,173],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100428384","phase-2-apollo-a-randomized-phase-ii-double-blind-study-of-olaparib-versus-placebo-following-curative-intent-therapy-in-patients-with-resected-pancreatic-cancer-and-a-pathogenic-brca1-brca2-or-palb2-mutation-100428384",false,"NCT04858334","APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation","Inclusion Criteria:\n\n* STEP 0 (PRE-REGISTRATION) INCLUSION CRITERIA\n* Patient must be \\>= 18 years of age on day of consent\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator\n\n  * NOTE: This includes patients with adenocarcinoma, acinar carcinoma, squamous cell carcinoma adenosquamous and variants thereof. Patients with neuroendocrine tumors are excluded from enrolling\n* Patient must (1) be planning to receive, (2) be receiving or (3) have received at least three combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 month course)\n* Patient must be no more than 12 weeks from their most recent treatment (this may be chemotherapy, radiotherapy or surgery)\n* Patient must have a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2, or PALB2, as determined by a Clinical Laboratory Improvement Amendments (CLIA) certified or equivalently-accredited laboratory. Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org\n* STEP 1 (RANDOMIZATION) INCLUSION CRITERIA\n* Patient must have met the eligibility criteria outlined above\n* Patient must have undergone at least 3 combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 months course)\n* Central expert reviewer must have determined the patient eligible for randomization after review of local genetic testing reports\n* If mutation in BRCA1, BRCA2 or PALB2 was identified in tumor tissue and the patient has not previously undergone germline testing, the patient must agree to undergo germline testing\n* Patient must have no evidence of recurrent or metastatic pancreatic cancer at the time of randomization as documented by baseline scans obtained =\\\u003C 4 weeks prior to Step 1 randomization\n* Patient must not have previously had evidence of progressive pancreatic cancer while receiving platinum-based therapy\n* Patient must be \\>= 21 days (three weeks) from their last treatment (including chemotherapy radiotherapy or surgery) but =\\\u003C 84 days (twelve weeks) from their last treatment at the time of Step 1 randomization. Patients who have received neoadjuvant and\u002For adjuvant radiotherapy are eligible\n* Patient must have recovered from any adverse events due to prior anti-cancer therapy (i.e., have no residual toxicities \\> grade 1 with the exception of alopecia and\u002For neuropathy)\n* Patient must not be receiving any other investigational agents at the time of Step 1 randomization and while on protocol treatment\n* Patient must not have any history of allergic reactions attributed to compounds of similar chemical or biological composition to olaparib\n* Patient must not have any personal history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of MDS\u002FAML\n* Patient must not have any uncontrolled gastrointestinal disorder that would, in the opinion of the investigator, interfere with the ingestion or absorption of olaparib\n* Patient must not be pregnant or breast-feeding due the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 1 randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 6 months after the last dose of protocol treatment for female patients and for 3 months after the last dose of protocol treatment for male patients. Patients must also not donate sperm while on protocol treatment and for 3 months after the last dose of protocol treatment. Patients must also not breast-feed while on protocol treatment and for 1 month after the last dose of protocol treatment\n* Leukocytes \\>= 3,000\u002FmcL (obtained =\\\u003C 28 days prior to Step 1 randomization)\n* Absolute neutrophil count \\>= 1,500\u002FmcL (obtained =\\\u003C 28 days prior to Step 1 randomization)\n* Platelets \\>= 100,000\u002FmcL (obtained =\\\u003C 28 days prior to Step 1 randomization)\n* Hemoglobin \\>= 9.0 g\u002FdL with no blood transfusion in the past 28 days (obtained =\\\u003C 28 days prior to Step 1 randomization)\n* Total bilirubin =\\\u003C 1.5 institutional upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin =\\\u003C 2.5 x ULN of the direct bilirubin (obtained =\\\u003C 28 days prior to Step 1 randomization)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN (obtained =\\\u003C 28 days prior to Step 1 randomization)\n* Creatinine =\\\u003C 1.5 institutional ULN OR calculated Cockcroft Gault creatinine clearance \\> 50 mL\u002Fmin\u002F1.73 m\\^2 (obtained =\\\u003C 28 days prior to Step 1 randomization)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patient must not have resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT \\[QTc\\] prolongation \\> 500 ms, electrolyte disturbances, etc.) or have congenital long QT syndrome\n* Concomitant use of known potent CYP3A4\u002F5 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir is prohibited\n* Patients who are being actively treated for an ongoing concurrent malignancy are ineligible, with the exception of those receiving adjuvant hormone therapies and those receiving topical therapies for skin cancers\n* Patient must not have, in the opinion of the investigator, any other concurrent medical condition that would prevent the patient from complying with the study procedures\n* Patient must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent\n* Patient must have the ability to understand and the willingness to sign a written informed consent document, or have legally authorized representative provide authorization to participate\n* Patient must not have had major surgery within 2 weeks prior to Step 1 randomization and patients must have recovered from any effects of any major surgery","ALL","18 Years",{"count":18,"type":19},152,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.",[25,26,27,28,29,30,31],"Pancreatic Acinar Cell Carcinoma","Pancreatic Adenosquamous Carcinoma","Pancreatic Squamous Cell Carcinoma","Resectable Pancreatic Acinar Cell Carcinoma","Resectable Pancreatic Adenocarcinoma","Resectable Pancreatic Adenosquamous Carcinoma","Resectable Pancreatic Carcinoma",[33,34,35,36,37,38,39,40,41,42,43],"Adjuvant","Resected Pancreatic cancer","Pancreatic adenocarcinoma","BRCA1","BRCA2","BRCA1 mutation","BRCA2 mutation","PALB2 PALB2 mutation","PARP inhibitor","PARP","Olaparib","RECRUITING","2026-07-01",{"date":47,"type":48},"2026-07-02","ACTUAL",{"date":50,"type":48},"2021-06-22",{"date":52,"type":19},"2027-10-31",{"name":54,"class":55},"National Cancer Institute (NCI)","NIH",454,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":20,"phases":66,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100548617","phase-2-gemcitabine-cisplatin-and-nab-paclitaxel-as-neoadjuvant-treatment-for-patients-with-resectable-or-borderline-resectable-pancreatic-cancer-100548617","NCT06423326","Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer","A Single-Arm Phase II Clinical Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed - resectable and borderline resectable pancreatic ductal adenocarcinoma\n\n  * Resectability will be defined as per National Comprehensive Cancer Network (NCCN) guidelines using cross-sectional imaging (contrast-enhanced computed tomography or magnetic resonance imaging scans of the abdomen, and pelvis)\n  * Decisions about resectability status will be made in consensus at multidisciplinary meetings\u002Fdiscussions\n\nResectable disease will be defined as:\n\n* No interface of the tumor with celiac artery, common hepatic artery (CHA), or superior mesenteric arteries (SMA) (and, if present, variants)\n* Less than 180° interface between tumor and vessel wall of the portal or superior mesenteric veins (SMV) without vein contour irregularity\n* For tumors of the body and tail of the pancreas, interface with the splenic artery and splenic vein of any degree will be considered resectable disease\n\nBorderline resectable disease will be defined as:\n\n* To include at least one of the following:\n\n  * Tumor abutment \\\u003C 180° of the superior mesenteric artery or celiac axis\n  * Solid tumor contact with CHA without extension to celiac artery (CA) or hepatic artery bifurcation allowing for safe and complete resection and reconstruction\n  * Solid tumor contact with variant arterial anatomy (ex: accessory right hepatic artery, replaced right hepatic artery, replaced CHA, and the origin of replaced or accessory artery)\n  * Tumor induced narrowing of SMV, portal vein (PV) or SMV-PV of \\> 180˚ of the diameter of the vessel\n  * Short segment occlusion of the SMV, PV or SMV-PV with a suitable PV above and SMV below, for reconstruction\n  * Solid tumor contact with inferior vena cava\n  * Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA)\n\n    * No distant extrapancreatic disease (M0)\n    * Adults \\> 18 years of age\n    * Able to give informed consent\n    * Able to adhere to study visit schedule and other protocol requirements\n    * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1\n    * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Ful\n    * Platelet count ≥ 100,000 cells\u002Ful\n    * Hemoglobin ≥ 9 g\u002FdL\n    * Serum total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n    * Albumin ≥ 3 g\u002Fdl\n    * Creatinine ≤ 1.5 x ULN\n    * Male, or a non-pregnant and non-lactating female\n    * Women of child-bearing potential - defined as a sexually mature woman who has not undergone hysterectomy - the surgical removal of the uterus or bilateral oophorectomy - the surgical removal of both ovaries or has not been naturally postmenopausal for at least 24 consecutive months, i.e., has had menses at any time during the preceding 24 consecutive months, must commit to true abstinence from heterosexual contact, or agree to use, and be able to comply with, effective contraception without interruption for 28 days prior to starting gemcitabine\u002Fcisplatin\u002Fnab- paclitaxel (including dose interruptions) until treatment with gemcitabine\u002Fcisplatin\u002Fnab-paclitaxel is complete\n    * Male subjects must practice true abstinence or agree to use a condom during sexual contact with a female of childbearing potential or a pregnant female while on treatment (including during dose interruptions) with gemcitabine\u002Fcisplatin\u002Fnab-paclitaxel and for 6 months following gemcitabine\u002Fcisplatin\u002Fnab- paclitaxel discontinuation, even if he has undergone a successful vasectomy\n\nExclusion Criteria:\n\n* Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as \"moderate symptoms; limiting instrumental activities of daily living (ADLs)\"\n* Concurrent severe and\u002For uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, uncontrolled diabetes, serious active, uncontrolled infection after inadequate biliary drainage if tumor obstructing bile duct, or psychiatric illness\u002Fsocial situations\n* Pregnancy (positive pregnancy test) or lactation\n* Known central nervous system (CNS) disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (radiosurgery \\[RS\\]; Gamma Knife, linear accelerator \\[LINAC\\], or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded\n* Previous (within the past 5 years) or concurrent presence of other untreated cancer, except nonmelanoma skin cancer and in situ carcinomas\n* History of allergy or hypersensitivity to any of the study drugs\n* Current abuse of alcohol or illicit drugs\n* Inability or unwillingness to sign the informed consent form",{"count":65,"type":19},36,[22],"This phase II trial tests how well gemcitabine, cisplatin and nab-paclitaxel given before surgery (neoadjuvant) works in treating patients with pancreatic cancer that can be removed by surgery (resectable) or that is borderline resectable. The standard treatment for resectable and borderline resectable pancreatic cancer is a combination of surgery and chemotherapy. Neoadjuvant therapy is more feasible and could improve outcomes compared to patients receiving surgery first. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel, an antimicrotubule agent that stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel may have fewer side effects and work better than other forms of paclitaxel. Gemcitabine, cisplatin and nab-paclitaxel may be an effective neoadjuvant treatment option for patients with resectable or borderline resectable pancreatic cancer.",[69,29,70,71,72],"Borderline Resectable Pancreatic Ductal Adenocarcinoma","Stage I Pancreatic Cancer AJCC v8","Stage II Pancreatic Cancer AJCC v8","Stage III Pancreatic Cancer AJCC v8","2026-04-17",{"date":75,"type":48},"2026-04-22",{"date":77,"type":48},"2024-08-06",{"date":79,"type":19},"2027-12-31",{"name":81,"class":82},"Emory University","OTHER",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":20,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100545642","phase-1-neoadjuvant-triple-therapy-for-borderline-resectable-pancreatic-cancer-preopanc-5-100545642","NCT06384560","Neoadjuvant Triple Therapy for (Borderline) Resectable Pancreatic Cancer (PREOPANC-5)","Neoadjuvant Triple Treatment With mFOLFIRINOX, Pembrolizumab and SABR in Patients With (Borderline) Resectable Pancreatic Cancer (PREOPANC-5): a Multicenter Single Arm Phase Ib\u002FII Trial of the Dutch Pancreatic Cancer Group","PREOPANC-5","Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the pancreas (WHO VI or VII)\n* Male or female participants who are at least 18 years of age on the day of signing informed consent\n* Primary resectable or borderline resectable disease (DPCG criteria)\n* ECOG performance status 0 or 1\n* Ability to undergo surgery, radiotherapy, chemotherapy and immunotherapy\n* Leucocytes (WBC) ≥ 3.0 X 10\\*9\u002Fl, Platelets ≥ 100X 10\\*9 \u002Fl, Hemoglobin ≥ 6 mmol\u002Fl, Renal function: E-GFR \\> 50 ml\u002Fmin, Bilirubin \\\u003C 50 µmol\u002Fl or planned for biliary drainage\n* A male participant must agree to use a contraception as detailed in Appendix 6 of this protocol during the treatment period and for at least 18 weeks after the last dose of study treatment and refrain from donating sperm during this period.\n* A female participant is eligible to participate if she is not pregnant (see Appendix 6), not breastfeeding, and at least one of the following conditions applies: Not a:\n\nwoman of childbearing potential (WOCBP) OR WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 18 weeks after the last dose of study treatment Written informed consent\n\nExclusion criteria\n\n* Metastatic or locally advanced (i.e. unresectable) pancreatic cancer.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).\n* Has received prior systemic anti-cancer therapy including investigational agents for pancreatic cancer.\n* Has received prior radiotherapy within 2 weeks of start of study intervention.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention\n* Complete dihydropyrimidine dehydrogenase deficiency. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid re placement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus infection.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Serious concomitant systemic disorders that would compromise the safety of the patient or their ability to complete the study, at the discretion of the investigator.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed.\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to start of treatment (see Appendix 6). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit until 18 weeks after the last dose of trial treatment.\n* Has contra-indications for MRI (only for Amsterdam UMC and RAKU)\n* Pacemakers or implanted defibrillators, deep brain stimulators, cochlear implants.\n* Patients who have a metallic foreign body in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal.\n* Patients with severe claustrophobia not able to tolerate an MRI scan",{"count":93,"type":19},66,[95,22],"PHASE1","Since patients with (borderline) resectable pancreatic cancer have a limited life expectancy, it is important to improve treatment strategies. Therefore, the objective of this study is to investigate whether neoadjuvant triple treatment with chemotherapy (mFOLFIRINOX), immunotherapy (pembrolizumab and stereotactic radiotherapy, followed by adjuvant surgery and chemotherapy and immunotherapy, improves survival in patients with (borderline) resectabel pancreatic cancer.",[98,99,29],"Localized Pancreatic Adenocarcinoma","Borderline Resectable Pancreatic Adenocarcinoma",[101,102,103,104,105,106,107,108,109,110,111],"neoadjuvant treatment","checkpoint inhibition","chemotherapy","stereotactic radiotherapy","surgical resection","progression free survival","resectable pancreatic cancer","localized pancreatic cancer","borderline resectable pancreatic cancer","FOLFIRINOX","pembrolizumab","2026-02-10",{"date":114,"type":48},"2026-02-13",{"date":116,"type":48},"2024-09-23",{"date":118,"type":19},"2028-03",{"name":120,"class":82},"Amsterdam UMC, location VUmc",4,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":130,"enrollmentInfo":131,"targetDuration":133,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100599094","a-cohort-study-on-ctdna-mrd-in-neoadjuvant-therapy-for-pancreatic-cancer-100599094","NCT07080021","A Cohort Study on ctDNA MRD in Neoadjuvant Therapy for Pancreatic Cancer","A Prospective Observational Cohort Study on Longitudinal Monitoring of ctDNA MRD in Neoadjuvant Therapy for Pancreatic Cancer","MRD","Inclusion Criteria:\n\n* Subjects meeting ALL of the following criteria will be enrolled:\n\n  1. Age and Gender :Aged 18-75 years, regardless of gender.\n  2. Diagnosis and Disease Stage :\n\n     Pathologically confirmed pancreatic cancer, meeting NCCN guideline criteria for:\n\n     A. High-risk resectable (meeting ≥1 criterion):\n     1. Luminal stenosis of the portal vein or superior mesenteric vein on imaging;\n     2. Radiographic stage T≥3 or N≥1;\n     3. Serum CA19-9 ≥1000 U\u002FmL (after resolution of jaundice);\n     4. Confirmed regional lymph node metastasis;\n     5. Significant weight loss (\\>10% baseline) or severe pain requiring opioids.\n\n     B. Borderline resectable :\n     1. Tumor involving the common hepatic artery without celiac axis contact;\n     2. Tumor contact with SMA ≤180°.\n\n     C. Locally advanced (unresectable):\n     1. Tumor encasement (\\>180°) of the SMA, celiac axis, or common hepatic artery;\n     2. Unreconstructable involvement of SMV\u002Fportal vein;\n     3. No distant metastasis.\n  3. Treatment Suitability :Deemed suitable for neoadjuvant therapy after multidisciplinary team (MDT) discussion .\n  4. Performance Status :ECOG (Eastern Cooperative Oncology Group) performance status ≤1 .\n  5. Life Expectancy :Estimated survival ≥6 months.\n  6. Organ Function :No severe cardiac, hepatic, or renal dysfunction, including:\n\n     ALT\u002FAST ≤3×ULN (upper limit of normal); Serum creatinine ≤1.5×ULN .\n  7. Informed Consent :Signed written informed consent voluntarily provided.\n\nExclusion Criteria:\n\n* Subjects meeting ANY of the following criteria will be excluded:\n\n  1. Distant Metastasis Radiographically confirmed distant metastatic lesions.\n  2. Prior Anti-Tumor Therapy History of any prior anti-tumor treatment, including:\n\n     Systemic chemotherapy Radiotherapy Interventional therapy Immunotherapy Targeted therapy Anti-tumor traditional Chinese medicine therapy.\n  3. Concurrent Malignancy Diagnosis of other active malignancies.\n  4. Pregnancy or Lactation Female subjects who are pregnant or breastfeeding.\n  5. Drug Allergy Hypersensitivity to any agents in the guideline-recommended first-line neoadjuvant regimen .\n  6. Transplantation History Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation .\n  7. Immunodeficiency Disorders Congenital or acquired immunodeficiency, including:\n\nHuman Immunodeficiency Virus (HIV) infection;\n\nActive Hepatitis B :\n\nHBsAg-positive andHBV-DNA ≥10,000 copies\u002FmL (≥2,000 IU\u002FmL) at screening;\n\nActive Hepatitis C :\n\nHCV-Ab-positive andHCV-RNA positive at screening; Co-infection with HBV and HC","75 Years",{"count":132,"type":19},119,"18 Months","OBSERVATIONAL","The goal of this prospective observational study is to learn about the clinical utility of dynamic ctDNA-based Minimal Residual Disease (MRD) monitoring in patients with borderline resectable pancreatic cancer undergoing neoadjuvant therapy. The main questions it aims to answer are:\n\n1. Does MRD negativity correlate with improved surgical outcomes (R0 resection rates) and long-term survival (Disease-Free Survival \\[DFS\\] \u002F Overall Survival \\[OS\\])?\n2. Can serial MRD status assessments guide optimal neoadjuvant therapy duration? Participants (n=119) will be adults aged 18-75 years with histologically confirmed pancreatic cancer meeting NCCN criteria for borderline resectable\u002Fhigh-risk resectable\u002Flocally advanced disease, deemed eligible for neoadjuvant therapy by a multidisciplinary team (MDT) and with ECOG performance status ≤1. Patients with distant metastasis, prior anticancer therapy, or concurrent malignancies are excluded.\n\nDuring 24-month study period (12-month recruitment + 12-month follow-up), enrolled subjects will:\n\n1. Receive standard-of-care neoadjuvant therapy\u002Fsurgery per physician's decision.\n2. Undo serial blood draws for ctDNA-MRD testing at predefined timepoints.\n\n2\\. Be followed for DFS\u002FOS outcomes for 18 months. This non-interventional study is conducted at Ruijin Hospital Pancreatic Surgery Department.",[99,29],"2025-07-24",{"date":139,"type":48},"2025-07-29",{"date":141,"type":48},"2025-05-20",{"date":143,"type":19},"2027-11-20",{"name":145,"class":82},"Ruijin Hospital",2,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":15,"minAge":153,"maxAge":130,"enrollmentInfo":154,"targetDuration":4,"studyType":20,"phases":156,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100578870","phase-2-perioperative-nalirifox-liposomal-irinotecan-in-combination-with-fluorouracil-leucovorin-and-oxaliplatin-in-resectable-pancreatic-adenocarcinoma-randomized-phase-ii-trial-100578870","NCT06816914","Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial","Inclusion Criteria:\n\n* previously untreated, histologically or cytologically proven PDAC\n* age between 20 and 75 years at registration\n* ECOG performance status of 0 or 1\n* AJCC (8th edition) clinical stage I or II with measurable disease (CT or MRI) in the pancreas. (positron emission tomography scan alone not allowed)\n* Surgically resectable disease according to NCCN criteria (Version 1.2023 - May 4, 2023):\n* no arterial tumor contact (celiac axis, superior mesentery artery, or common hepatic artery).\n* no tumor contact with the superior mesentery vein or portal vein or ≤180° contact without vein contour irregularity.\n* adequate major organ functions\n* Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) must agree to use contraception from the time ofinformed consent until 6 months or more after the last dose of investigational products. Also, women must agree not to breastfeed from the time of informed consent until 6 months or more after the last dose of the investigational product.\n* Men must agree to use contraception from the start of study treatment until 3 months or more after the last dose of the investigational product.\n* Participants must have signed written informed consent form in accordance with regulatory and institutional guidelines.\n\nExclusion Criteria:\n\n* presence of clinically significant co-morbid medical conditions within 4 weeks prior registration judged by Investigators\n* severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in past 6 months\n* New York Heart Association class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure or known abnormal electrocardiogram (ECG) with clinically significant abnormal findings in past 6 months\n* interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity within 28 days prior to registration\n* presence of diarrhea ≥ CTCAE v.5.0 grade 2\n* concomitant systemic infection requiring treatment\n* prior organ allograft or allogeneic bone marrow transplantation\n* known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome\n* prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer\n* any major surgery within 4 weeks of study treatment. Participants must have recovered from the effects of major surgery or significant traumatic injury at least 4 weeks before study treatment.\n* pregnant women or nursing mothers, or positive pregnancy tests\n* severe mental disorder\n* current use or any use in past 2 weeks of strong cytochrome P450 3A4 enzyme inducers\u002Finhibitors and\u002For strong UGT1A inhibitors\n* known hypersensitivity to any of the components of study drugs","20 Years",{"count":155,"type":19},84,[22],"To explore the safety and activity of NALIRIFOX (liposomal irinotecan in combination with fluorouracil, leucovorin, and oxaliplatin) in the perioperative and adjuvant treatment in resectable pancreatic adeneocarcinoma.",[29],[160,161,162],"Perioperative","NALIRIFOX","resectable pancreatic adenocarcinoma","2025-02-18",{"date":165,"type":48},"2025-02-20",{"date":167,"type":19},"2025-03-05",{"date":169,"type":19},"2028-02-05",{"name":171,"class":82},"Taichung Veterans General Hospital",9,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":20,"phases":182,"briefSummary":184,"conditions":185,"keywords":191,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":83},"100565999","evaluation-in-humans-of-the-correlation-between-hepatotoxicity-neurotoxicity-induced-by-oxaliplatin-and-blood-levels-of-hmgb1-100565999","NCT06649474","Evaluation, in Humans, of the Correlation Between Hepatotoxicity, Neurotoxicity Induced by Oxaliplatin, and Blood Levels of HMGB1","HEPATOXALI","Inclusion Criteria:\n\n* ECOG WHO Performance status = 0 or 1\n* Signed and dated informed consent\n* Patients with histological diagnosis of oesogastric or pancreatic adenocarcinoma\n* Resectable tumors\n* Patients able to have a laparoscopy\n* In case of absence of peritoneal invasion on the laparoscopy, patient candidate to a chemotherapy schedule by FLOT or FOLFOX in perioperative setting for oesogastric adenocarcinoma, or FOLFIRINOX in perioperative setting for pancreatic adenocarcinoma\n* Registration in a national health care system (CMU included)\n* Patient speak and understand the french\n\nExclusion Criteria:\n\n* Histology other than adenocarcinoma\n* Metastatic disease\n* History of previous treatment with oxaliplatine\n* History of systemic chemotherapy administration within 5 years prior to inclusion,\n* Patient with an non balanced progressive condition\u002Fdisease (liver failure, renal failure (creatinine clearance \\<30mL\u002Fmin), respiratory failure, congestive heart failure, myocardial infarction in the last 6 months, etc.),\n* Patient on curative dose anticoagulant,\n* Patient with complete dihydropyrimidine dehydrogenase deficiency (Uracilemia ≥ 150 ng\u002Fml),\n* Patient not operable for the pathology concerned,\n* Pregnant or breastfeeding woman, woman of childbearing age who has not performed a pregnancy test before the procedure,\n* Patient with legal incapacity (person deprived of liberty or under curatorship, stutorship, safeguard of justice),\n* Patient who, for psychiatric, social, family or geographical reasons, cannot be followed and\u002For comply with the requirements of the study,,\n* Discovery of peritoneal invasion during the peritoneal exploratory of the laparoscopy",{"count":181,"type":19},100,[183],"NA","Oesogastric and pancreatic adenocarcinomas are poor-prognosis cancers. Incidence of pancreatic cancer drastically increases to such an extent that it will become the second cause of cancer's mortality by 2030. A major challenge is to optimize the therapies for localized setting, when oxaliplatin-based chemotherapy is the standard, before and after surgical excision. Because in 50% of cases oxaliplatin triggers a grade 2-3 sinusoidal obstruction syndrome (SOS) which increases post-operative morbidity, decreases histological response to chemotherapy, increases tumor recurrence, and aggravates the risk of chemotherapy-induced peripheral neuropathy (CIPN).\n\nThere is an urgent need to better understand the biological processes involved in SOS, in order to prevent and treat it without stopping or reducing oxaliplatin administration.\n\nThe biological link between oxaliplatin and SOS has not been described, but recent murine experiments argue for HMGB1 to be the mediator released after exposure to oxaliplatin and inducing SOS, and thereafter CIPN. To date, no biomarker is established between murine and patient analyses, and the release of HMGB1 after oxaliplatin treatment and its effect on hepatic parenchyma is not described in patients. Investigators hypothesized is that HMGB1 would also been increased in patients after oxaliplatin treatment, and correlated to the development of SOS and CIPN. If confirmed, personalized treatment will be possible to target this pathway.\n\nTherefore, investigators propose to dynamically explore this hypothesis in localized oesogastric and pancreatic cancer patients who will be routinely managed by an initial laparoscopy and post-oxaliplatin surgical excision.",[186,29,187,188,189,190],"Pancreatic Cancer","Adenocarcinoma","Resectable Esophageal Cancer","Resectable Gastric or Gastroesophageal Junction Adenocarcinoma","Oesophagogastric Cancer",[192,193,194],"resecable pancreatic, oesophageal, gastric or gastroesophageal junction adenocarcinoma.","Patients able to have a laparoscopy","chemotherapy before surgery","2024-10-17",{"date":197,"type":48},"2024-10-18",{"date":199,"type":48},"2024-09-06",{"date":201,"type":19},"2028-06-30",{"name":203,"class":82},"University Hospital, Clermont-Ferrand"]