[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"borderline-resectable-pancreatic-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:borderline-resectable-pancreatic-adenocarcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,43,67,89,116,139,174,197,223],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100567809","phase-1-ptm-101-in-pancreatic-ductal-adenocarcinoma-pdac-100567809",false,"NCT06673017","PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)","A Phase Ib Dose Escalation\u002FDose Expansion Study of PTM-101 as an Adjunct to Neoadjuvant Therapy for Treatment Naïve, Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)","Inclusion Criteria:\n\n* Imaging consistent with primary borderline resectable or locally advanced PDAC. PDAC may be confirmed by histology\u002Fcytology either at study-mandated laparoscopy or by prior biopsy\u002Fcytology\n* Indicated for laparoscopy\n* No prior therapy of any kind for PDAC\n* Acceptable laboratory values\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2\n* Ability to provide informed consent\n* No symptomatic pancreatitis\n* No other active medical issues which would confound interpretation of safety monitoring, efficacy results or prevent the subject from study participation\n* Subjects with childbearing potential must agree to use adequate contraception throughout study participation\n\nExclusion Criteria:\n\n* Active non-pancreatic cancer that currently requires treatment or is being treated; diagnosis of another malignancy within the past 2 years. This criterion excludes a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancers, or superficial bladder cancer that has been adequately treated, or stage 1 prostate cancer that does not require treatment or requires only treatment with luteinizing hormone-releasing hormone agonists or antagonists if initiated at least 30 days prior to screening). Other potentially indolent cancers may be considered.\n* Contraindications or allergies to paclitaxel, PLGA (poly(lactic-co-glycolic ) acid), or contraindications to implantation of PTM-101 or chemotherapies in protocol (e.g., FOLFIRINOX, gemcitabine, nab-paclitaxel)\n* Known history of human immunodeficiency virus (HIV) or active viral hepatitis\n* Active ongoing infection or autoimmune disease which may preclude laparoscopy, placement of PTM-101, administration of chemotherapy or surgical resection of pancreatic tumor\n* Inability to comply with activities and therapeutic interventions as outlined in the schedule of events\n* Currently enrolled in another investigational drug or device trial\n* Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeed; men who plan to donate sperm or conceive a child\n* Any other medical or surgical conditions, including prior abdominal surgery, that would preclude safe laparoscopy or implantation in the opinion of the investigator","ALL","18 Years",{"count":19,"type":20},26,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a multi-center, non-randomized, single-arm, open-label, phase Ib, dose escalation\u002Fdose expansion study of PTM-101 when combined with neoadjuvant chemotherapy for the treatment of treatment-naïve subjects with borderline resectable and locally advanced pancreatic ductal adenocarcinoma (PDAC).",[26,27,28,29],"Pancreatic Ductal Adenocarcinoma","Borderline Resectable Pancreatic Adenocarcinoma","Locally Advanced Pancreatic Adenocarcinoma","Pancreatic Cancer","RECRUITING","2026-05-19",{"date":33,"type":34},"2026-05-20","ACTUAL",{"date":36,"type":34},"2025-04-14",{"date":38,"type":20},"2028-06",{"name":40,"class":41},"PanTher Therapeutics","INDUSTRY",6,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100492136","phase-1-zimberelimab-and-quemliclustat-in-combination-with-chemotherapy-for-the-treatment-of-patients-with-borderline-resectable-and-locally-advanced-pancreatic-adenocarcinoma-100492136","NCT05688215","Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma","A Pilot Study of Zimberelimab and Quemliclustat Combination With Chemotherapy in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n* Male or female \\>= 18 years of age and willing and able to provide informed consent\n* Previously untreated cytologically or histologically confirmed pancreatic adenocarcinoma with one of the following:\n\n  * Borderline resectable disease. There are multiple definitions of borderline resectable PDAC including the MD Anderson definition and the criteria developed during the Consensus Conference sponsored by the American Hepato-Pancreato-Biliary Association, Society of Surgical Oncology, and Society for Surgery of the Alimentary Tract. Borderline resectable PDAC cases will be identified per the definition developed in the currently running inter-group pilot trial for borderline resectable pancreatic cancer (NCT01821612). Per this trial, borderline resectable PDAC is defined as the presence of any one or more of the following on CT;\n\n    * An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring \\>= 180 degrees of the circumference of the vessel wall\n    * Short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction\n    * Short segment interface (of any degree) between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and reconstruction\n    * An interface between the tumor and SMA measuring \\\u003C 180 degrees of the circumference of the vessel wall\n  * Locally advanced disease. Multiple guidelines defining locally advanced PDAC have been developed, including the MD Anderson definition, the National Comprehensive Cancer Network (NCCN) definition, as well as the criteria developed during the Consensus Conference sponsored by the American Hepato-Pancreato-Biliary Association, Society of Surgical Oncology, and Society for Surgery of the Alimentary Tract. Locally advanced PDAC cases will be identified per the definition developed by the Alliance for Clinical Trials in Oncology. Per this definition, locally advanced PDAC is defined as presence of any one or more of the following on CT;\n\n    * Occlusion of the SMV-PV that is not amenable to resection and venous reconstruction\n    * Interface between tumor and hepatic artery that is not amenable to resection and reconstruction\n    * Interface between the tumor and SMA measuring \\> 180 degrees of the circumference of the vessel wall\n    * Interface between the tumor and celiac axis measuring \\> 180 degrees of the circumference of the vessel wall\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL\n* Platelets \\>= 100 x 10\\^9\u002FL\n* Hemoglobin \\>= 9 g\u002FdL\n* Serum creatinine (sCr) =\\\u003C 1.5 x upper limit of normal (ULN) or Creatinine clearance (Ccr) \\>= 40 mL\u002Fmin (as calculated by Modified Cockcroft-Gault formula)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (AST\u002F\\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 X ULN\n* Women with no childbearing potential because of surgery or who are at least 1 year postmenopausal (ie, 12 months post last menstrual period) or with menopause confirmed by follicle-stimulating hormone testing\n* Women of childbearing potential must use an effective nonhormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap \\[diaphragm or cervical or vault caps\\] with spermicidal foam or gel or film or cream or suppository; or vasectomized male partner if he is the sole partner of that participant) for the duration of the study and for up to 6 months after the last dose of zimberelimab or quemliclustat\n* Male participants must use an effective method of contraception (condom or occlusive cap \\[diaphragm or cervical or vault caps\\] with spermicidal foam or gel or film or cream or suppository, or vasectomy) throughout the study and for up to 6 months after the last dose of zimberelimab or quemliclustat\n* Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses \\> 10 mg\u002Fday prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before study treatment administration. Physiologic doses of corticosteroids (=\\\u003C 10 mg\u002Fday of prednisone or its equivalent) or short pulses of corticosteroids (=\\\u003C 3 days) may be permitted\n* Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before study treatment administration. Surgery requiring regional\u002Fepidural anesthesia must be completed at least 72 hours before study treatment administration. Participants should have recovered from the surgical procedure prior to the first dose being administered\n\nExclusion Criteria:\n\n* Recurrent or metastatic pancreatic adenocarcinoma\n* Peripheral neuropathy \\> grade 2\n* Known status of human immunodeficiency virus (HIV) which is not well-controlled (CD4 \\\u003C300) at the time of study eligibility. Patients with controlled and treated HIV\u002FHepatitis C virus (HCV) and an undetectable viral load are allowed\n* Untreated Hepatitis B infection: Patient has known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or Human immunodeficiency virus (HIV) infection (testing is not mandatory, unless required by local regulation)\n\n  * Participants with resolved or treated HCV (ie, HCV antibody positive but undetectable HCV ribonucleic acid \\[RNA\\]) will not be excluded from this study\n* Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational products (IPs) hazardous, including but not limited to:\n\n  * Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis (lymphangitic spread of non-small cell lung cancer (NSCLC) is not disqualifying)\n  * Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of the IP\n  * Active infection or antibiotics within 48 hours prior to study screening\n  * Clinically significant cardiovascular disease\n  * A condition or unresolved adverse event (AE) from a prior investigational drug that may obscure the interpretation of toxicity determination or AEs\n  * History of prior solid-organ transplantation\n* Currently active second primary malignancy or history of malignancy less than 5 years prior to the time of study eligibility (Patients with history of skin cancers excluding melanoma will be eligible for participation)\n* Serious medical comorbidities such as New York Heart Association Class III\u002FIV cardiac disease, uncontrolled cardiac arrhythmias, myocardial infarction over the past 12 months\n* Known, existing uncontrolled coagulopathy. Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation are eligible IF: they are appropriately anticoagulated and have not had a Grade 2 or greater bleeding episode in the 3 weeks before Day 1\n* Known pregnancy, nursing women or positive pregnancy test. Requirement for women of child-bearing potential (WOCBP): Negative serum pregnancy test at screening and prior to dosing on Cycle 1 Day 1, within 24 hours prior to the start of treatment (minimum sensitivity 25 IU\u002FL or equivalent units of HCG). WOCBP must also have a negative serum or urine pregnancy test every 4 weeks, within 24 hours prior to the start of treatment\n* Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator\n* History of trauma or major surgery within 28 days prior to the first dose of IP\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Any active or documented history of autoimmune disease, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment, except for the following:\n\n  * Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders such as vitiligo, or alopecia not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger\n  * Endocrinopathies where the participant is stable on hormone replacement therapy\n  * History of Hashimoto syndrome within 3 years of the first of study treatment that resolved to hypothyroidism alone\n* History of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma\u002Fatopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study",{"count":51,"type":20},56,[23,53],"PHASE2","This phase I\u002FII study tests how well zimberelimab and quemliclustat work in combination with chemotherapy (mFOLFIRINOX) in treating patients pancreatic adenocarcinoma that may or may not be able to be removed by surgery (borderline resectable) or that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as zimberelimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Quemliclustat acts as a blocker for adenosine. Adenosine is a chemical produced in the body that can lead to a decrease in the immune system's response towards cancer. Quemliclustat has the potential to decrease the amount of adenosine, allowing the immune system to recognize and act against the cancer. Chemotherapy drugs, such as oxaliplatin, irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy in combination with zimberelimab and quemliclustat may kill more cancer cells than chemotherapy alone.",[27,56],"Locally Advanced Pancreatic Ductal Adenocarcinoma",{"date":58,"type":34},"2026-05-22",{"date":60,"type":34},"2023-03-07",{"date":62,"type":20},"2027-03-02",{"name":64,"class":65},"Jonsson Comprehensive Cancer Center","OTHER",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":66},"100502654","phase-2-neoadjuvant-chemotherapy-for-borderline-resectable-and-locally-advanced-pancreatic-adenocarcinoma-100502654","NCT05825066","Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma","Sequential Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n* Patients must have histologically or cytologically proven adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled\n* Patients with borderline resectable or locally advanced pancreatic adenocarcinoma as assessed per National Comprehensive Cancer Network (NCCN) guidelines (either pancreatic head, neck, uncinate process, or body\u002Ftail) or institutional multidisciplinary consensus\n* Age 18 or above\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1\n* Patients must have organ and marrow function as defined below:\n\nHemoglobin\\* ≥8 g\u002FdL Absolute neutrophil count ≥1,500\u002FmcL Platelets\\* ≥100,000\u002FmcL Total bilirubin\\* ≤1.5 X institutional upper limit of normal AST(SGOT)\u002FALT(SGPT) \\\u003C2.5 X institutional upper limit of normal Creatinine ≤1.5 X institutional upper limit of normal or CrCL\\>50\n\n* It is acceptable to transfuse packed red blood cells (PRBC) and platelets at the time of enrollment to meet the eligibility criteria.\n* If obstructive jaundice is present, consider ursodiol or a biliary drainage procedure. If the total bilirubin can be reduced or kept to less than or equal to 3 mg\u002FdL, then this inclusion criteria is met.\n\n  * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n  * Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative)\n\nExclusion Criteria:\n\n* Patients who have had prior chemotherapy with gemcitabine and\u002For nab-paclitaxel or FOLFIRINOX for pancreatic cancer\n* Patients receiving any other investigational anti-neoplastic agents\n* History of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible\n* Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy for the infection is completed\n* Uncontrolled intercurrent illness including, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the patient's safety\n* Patients with known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis, or pneumonitis requiring oxygen supplementation. Those that do not require oxygen supplementation are eligible.\n* Patients who have undergone surgery, other than diagnostic or minor procedures, within 4 weeks prior to the initiation of study treatment\n* Patients who are pregnant or breastfeeding",{"count":75,"type":20},64,[53],"The objective of this research is to find out what effects (good and bad), the sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX, the standard chemotherapy for pancreatic cancer, has on participants and their condition. Gemcitabine - Abraxane (nab-Paclitaxel) and mFOLFIRINOX has been approved by the US Food and Drug Administration (FDA) as first line treatment for advanced pancreatic cancer. The sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX has not been approved by the FDA for treatment of pancreatic cancer.",[79,27,28],"Pancreas Adenocarcinoma","2026-03-23",{"date":82,"type":34},"2026-03-25",{"date":84,"type":34},"2023-08-01",{"date":86,"type":20},"2028-07",{"name":88,"class":65},"Wake Forest University Health Sciences",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":102,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":66},"100624891","phase-2-ibi343-combined-with-chemotherapy-as-neoadjuvant-therapy-in-borderline-resectable-pancreatic-cancer-100624891","NCT07415525","IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Borderline Resectable Pancreatic Cancer","A Phase II Clinical Study Evaluating the Safety and Efficacy of IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Subjects With Borderline Resectable Pancreatic Cancer","Inclusion Criteria:\n\n* (1)Sign a written Informed Consent Form (ICF), willing and able to comply with the visits and related procedures specified in the protocol.\n* (2)Histopathologically confirmed pancreatic adenocarcinoma.\n* (3)No evidence of distant metastasis as assessed by imaging (must include chest, abdomen, and pelvis). Bone scan or PET\u002FCT may be performed for confirmation if necessary.\n* (4)Confirmed borderline resectable pancreatic cancer as assessed by imaging (abdominal contrast-enhanced CT or contrast-enhanced MRI), with resectability determined according to the NCCN 2025.V2 guidelines for pancreatic cancer.\n* (5)No prior anti-tumor treatment for the studied disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.\n* (6)Age ≥18 years and ≤75 years, regardless of gender.\n* (7)Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.\n* (8)Expected survival ≥12 weeks.\n* (9)Adequate bone marrow and organ function.\n* (10)Female subjects of childbearing potential or male subjects with female partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months after treatment.\n* (11)Confirmed \\*CLDN18.2 positivity by pathological tissue testing. \\*CLDN18.2 positivity is defined as Claudin18.2 immunohistochemical membrane staining intensity ≥1+ in ≥50% of tumor cells, accepting previous test results, results from the research center, or laboratory test results. Regarding the proportion of CLDN18.2 expression, the investigator and sponsor may dynamically adjust the criteria during the study based on newly generated data and data from other studies.\n\nExclusion Criteria:\n\n* (1)Currently participating in another interventional clinical study, excluding observational (non-interventional) clinical studies or being in the survival follow-up phase of an interventional study.\n* (2)The tumor is a locally recurrent lesion.\n* (3)Received treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) before the first dose of the investigational drug.\n* (4)Underwent biliary stent implantation or PTCD within 7 days before the first dose of the investigational drug.\n* (5)Received any live vaccine within 4 weeks before the first dose of the investigational drug or plans to receive one during the study period.\n* (6)Underwent major surgical procedures (craniotomy, thoracotomy, laparotomy, or other surgeries defined by the investigator, excluding needle biopsy) within 4 weeks before the first dose of the investigational drug, or has unhealed wounds, ulcers, or fractures; or plans to undergo major surgery during the study period.\n* (7)History of gastrointestinal perforation and\u002For fistula within the past 6 months before the first dose of the investigational drug, which has not been resolved through surgical treatment.\n* (8)Pyloric obstruction affecting eating or gastric emptying that cannot be improved by jejunal feeding tube placement.\n* (9)Post-implantation of a stent in the digestive tract (referring to the muscular tube from the mouth to the anal canal, including the mouth, pharynx, esophagus, stomach, small intestine (duodenum, jejunum, ileum), large intestine (cecum, appendix, colon, rectum), and anal canal) or trachea. (Excluding stent placement included as part of radical surgery, such as duodenal stent placement in subjects with pancreatic head cancer.)\n* (10)Interstitial lung disease requiring steroid treatment, or a history of interstitial lung disease, non-infectious pneumonia, severely impaired lung function, or uncontrolled pulmonary conditions such as pulmonary fibrosis, severe radiation pneumonitis, acute lung injury, etc., or suspicion of the above conditions during screening.\n* (11)Presence of uncontrolled diseases.\n* (12)History of other primary malignancies.\n* (13)Known history of immunodeficiency.\n* (14)History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* (15)Previously received antibody-drug conjugate therapy based on topoisomerase inhibitors.\n* (16)For subjects receiving medication, a history of allergy to the corresponding drug or formulation.\n* (17)For subjects receiving medication, contraindications to the corresponding drug.\n* (18)For subjects receiving medication, a history of permanent discontinuation of the corresponding drug due to adverse reactions.\n* (19)Pregnant or breastfeeding female subjects.\n* (20)Other conditions considered by the investigator as not suitable for participation in this study.","75 Years",{"count":98,"type":20},40,[53],"This study is a Phase II trial evaluating the safety and efficacy of IBI343 in combination with chemotherapy as neoadjuvant therapy for subjects with borderline resectable pancreatic cancer (BRPC). The study enrolls treatment-naïve subjects with CLDN18.2-positive BRPC, confirmed by imaging and pathological diagnosis. Subjects will receive 4 cycles of neoadjuvant therapy. During or after neoadjuvant therapy, subjects who are unable to undergo radical surgical resection due to disease progression or other reasons will discontinue study treatment. After imaging assessment, subjects deemed eligible for radical resection by a multidisciplinary team (MDT) will undergo radical surgery 14-28 days after the last dose of neoadjuvant therapy . Following surgery, subjects will receive adjuvant therapy with the AG regimen or investigator-selected adjuvant chemotherapy. Adjuvant therapy will begin 21-56 days post-surgery, and the total duration of preoperative neoadjuvant and postoperative adjuvant therapy will be 6 months. Subjects will continue adjuvant therapy until the planned treatment duration is completed, or until disease recurrence, intolerable toxicity, withdrawal of informed consent, loss to follow-up, death, or other treatment discontinuation criteria are met (whichever occurs first). After discontinuation of study treatment, subjects will undergo safety follow-up and survival follow-up.",[29,27],[103,104,105],"borderline resectable pancreatic adenocarcinoma","Claudin 18.2 positive","neoadjuvant therapy","NOT_YET_RECRUITING","2026-02-10",{"date":109,"type":34},"2026-02-17",{"date":111,"type":20},"2026-02-01",{"date":113,"type":20},"2030-12-31",{"name":115,"class":65},"Zhejiang University",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":96,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":127,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100611452","phase-2-hrs-4642-in-combination-with-nimotuzumab-and-chemotherapy-for-brpc-with-kras-g12d-mutation-100611452","NCT07240766","HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation","Phase II Study of HRS-4642 in Combination With Nimotuzumab and Chemotherapy for Subjects With Borderline Resectable Pancreatic Cancer With KRAS G12D Mutation","Inclusion Criteria:\n\n* Aged between 18 and 75 years (inclusive).\n* Histopathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium).\n* Radiologically confirmed borderline resectable pancreatic cancer (according to the latest NCCN guidelines definition), with no distant metastases.\n* Tumor tissue testing confirms KRAS G12D mutation.\n* No prior systemic anti-tumor therapy.\n* At least one evaluable lesion according to RECIST v1.1 criteria.\n* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.\n* Expected survival time ≥ 3 months.\n* Adequate organ function meeting the following requirements (no use of any blood components or colony-stimulating factors within 2 weeks prior to enrollment):\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n  2. Platelets ≥ 80 × 10⁹\u002FL\n  3. Hemoglobin ≥ 100 g\u002FL\n  4. Serum albumin ≥ 30 g\u002FL\n  5. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN and ALP ≤ 2.5 × ULN\n  6. Creatinine clearance ≥ 50 mL\u002Fmin or Serum creatinine ≤ 1.5 × ULN (Calculation formula see section 13.3)\n  7. Electrocardiogram: QTcF ≤ 450 ms (male), QTcF ≤ 470 ms (female)\n  8. Cardiac ultrasound: LVEF (Left Ventricular Ejection Fraction) ≥ 50%\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment, must be non-lactating, and must be willing to use adequate contraception during the trial and for 6 months after the end of treatment. For men, they must be surgically sterile or agree to use adequate contraception during the study and for 6 months after the end of treatment.\n* Voluntary participation in this study and signing of informed consent, good compliance, and agreement to cooperate with follow-up.\n\nExclusion Criteria:\n\n* 1\\. Prior Treatment:\n\n  1. Major surgical procedure or significant traumatic injury within 4 weeks prior to enrollment, or palliative local therapy (including but not limited to palliative radiotherapy, interventional therapy) within 2 weeks prior to enrollment.\n  2. Treatment with any investigational drug from another clinical study within 4 weeks prior to enrollment, except for participation in an observational (non-interventional) clinical study or the follow-up phase of an interventional study.\n  3. Use of strong inhibitors or inducers of hepatic drug-metabolizing enzymes CYP3A4 or CYP2C8 within 14 days prior to enrollment.\n* 2\\. Acute or chronic pancreatitis requiring clinical intervention.\n* 3\\. History or presence of symptoms\u002Fsigns of gastrointestinal obstruction within 6 months prior to the start of study treatment. Subjects may be screened if they have undergone surgical procedure resulting in complete resolution of the obstruction.\n* 4\\. Third-space fluid accumulation (e.g., significant pleural effusion, ascites, etc.) that is unstable (unable to remain stable without intervention after drainage removal) within 2 weeks prior to enrollment. Subjects with only small amounts of fluid visible on imaging and without clinical symptoms may be enrolled.\n* 5\\. Severe infection within 4 weeks prior to enrollment, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; Unexplained fever \\>38.5°C within 2 weeks prior to enrollment (subjects with fever judged by the investigator to be due to the tumor may be enrolled); Presence of signs\u002Fsymptoms of infection requiring intravenous antibiotic therapy within 2 weeks prior to enrollment (excluding prophylactic antibiotic use).\n* 6\\. Severe cardiovascular and cerebrovascular diseases:\n\n  1. Important arterial\u002Fvenous thrombotic events within 6 months prior to enrollment, such as cerebrovascular accident (including cerebral hemorrhage, cerebral infarction), deep vein thrombosis (excluding muscular venous thrombosis not requiring anticoagulation), and pulmonary embolism.\n  2. Poorly controlled cardiac symptoms or diseases, such as:\n\n     1. Myocardial infarction within 6 months.\n     2. Unstable angina.\n     3. Heart failure of NYHA class II or above.\n     4. Subjects with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n* 7\\. Patients with known or suspected interstitial lung disease, with the exception of interstitial changes visible only on imaging without clinical symptoms.\n* 8\\. History of definite neurological or psychiatric disorders, including epilepsy and dementia.\n* 9\\. Presence of non-healed wounds (severe, non-healing, or dehisced) or unhealed fractures.\n* 10\\. Adverse events from prior anti-cancer therapy have not recovered to NCI-CTCAE grade ≤1 (except for alopecia and parameters already specified in the inclusion criteria; except for AEs judged by the investigator as not affecting study drug administration).\n* 11\\. History of other malignant tumors within 5 years prior to enrollment, except for those with low risk of metastasis and death: adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, etc.\n* 12\\. Concurrent active Hepatitis B (if HBsAg positive, HBV DNA must be tested; HBV DNA \\\u003C2000 IU\u002FmL is required for enrollment and the subject must receive standard antiviral therapy during the study), Hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection of the assay). Known history of acquired immunodeficiency syndrome or positive HIV test. Active syphilis infection. Active tuberculosis or history of active tuberculosis infection within 48 weeks prior to screening, regardless of treatment.\n* 13\\. Known allergy to any component of HRS-4642; history of allergy to Nimotuzumab, other monoclonal antibody\u002Ffusion protein drugs, albumin-bound paclitaxel, or gemcitabine.\n* 14\\. Any other condition that, in the judgment of the investigator, may affect the study results or lead to the premature termination of the study, such as alcoholism, drug abuse, other serious concomitant diseases (including psychiatric disorders) requiring treatment, severely abnormal laboratory test values, family or social factors, and other circumstances that may affect patient safety or reliability of data collection.",{"count":98,"type":20},[53],"This study is a Phase II clinical trial that plans to enroll 40 patients with borderline resectable pancreatic cancer harboring a KRAS G12D mutation, aiming to evaluate the efficacy of HRS-4642 in combination with Nimotuzumab and AG in borderline resectable pancreatic cancer. The study process includes a screening period (from the signing of the informed consent form until the first dose), a treatment period (from the first dose to the discontinuation of study treatment), and a follow-up period (safety follow-up and survival follow-up after the discontinuation of study treatment).",[27],[128,129,130],"pancreatic adenocarcinoma","borderline resectable","KRAS G12D mutation",{"date":132,"type":34},"2026-02-13",{"date":134,"type":20},"2026-02-15",{"date":136,"type":20},"2028-11-15",{"name":115,"class":65},2,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":154,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"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":148,"type":20},66,[23,53],"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.",[152,27,153],"Localized Pancreatic Adenocarcinoma","Resectable Pancreatic Adenocarcinoma",[155,156,157,158,159,160,161,162,163,164,165],"neoadjuvant treatment","checkpoint inhibition","chemotherapy","stereotactic radiotherapy","surgical resection","progression free survival","resectable pancreatic cancer","localized pancreatic cancer","borderline resectable pancreatic cancer","FOLFIRINOX","pembrolizumab",{"date":132,"type":34},{"date":168,"type":34},"2024-09-23",{"date":170,"type":20},"2028-03",{"name":172,"class":65},"Amsterdam UMC, location VUmc",4,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":96,"enrollmentInfo":182,"targetDuration":184,"studyType":185,"phases":4,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":138},"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",{"count":183,"type":20},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.",[27,153],"2025-07-24",{"date":190,"type":34},"2025-07-29",{"date":192,"type":34},"2025-05-20",{"date":194,"type":20},"2027-11-20",{"name":196,"class":65},"Ruijin Hospital",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":207,"briefSummary":208,"conditions":209,"keywords":212,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":220,"locationsCount":222},"100445654","phase-2-preoperative-mfolfirinox-or-gem-nab-p---isotoxic-high-dose-sbrt-for-borderline-resectable-pancreatic-adenocarcinoma-100445654","NCT05083247","Preoperative mFOLFIRINOX (or Gem-Nab-P) +\u002F- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma","Preoperative Treatment With mFOLFIRINOX (or Gem-Nab-P) +\u002F- Isotoxic High-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for Borderline Resectable Pancreatic Adenocarcinoma: a Randomised Phase II Study (STEREOPAC)","STEREOPAC","Inclusion criteria:\n\n* Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinated process or body or tail. Diagnosis should be verified by local pathologist\n* cTNM stage: T1-4N0-2M0\n* Confirmation of clinical and radiographic stage as borderline resectable (CT scan and\u002For MRI scan with contrast according to the NCCN criteria) by a multidisciplinary board, composed by a dedicated oncological surgeon, radiologist and GI oncologist)\n* Age \\> 18 years old\n* No prior chemotherapy or radiation for pancreatic cancer\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* No grade ≥ 2 neuropathy\n* Laboratory parameters as follows:\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³\n* Platelet count ≥ 100,000\u002Fmm³\n* Hemoglobin ≥ 9 g\u002FdL\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated GFR \\>45 mL\u002Fmin\n* Bilirubin ≤ 1.5 x ULN, including after adequate biliary stenting with metal stent (ideally 4 cm length)\n* Aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) ≤ 2.5x ULN\n* CA 19.9 \\\u003C 2500 kU\u002Fl (baseline, prior to any therapy and absence of cholestasis)\n\nExclusion Criteria:\n\n* Evidence of extrapancreatic disease on diagnostic imaging (CT, MRI or PET scan), histologically proven or at laparoscopy, including distal nodal involvement beyond the peripancreatic tissues (including non-regional lymph node involvement, ie: proven involvement of precaval lumbar lymphadenopathy(ies) and\u002For distant metastases\n* Locally advanced disease as defined by the NCCN criteria (version 2.2021) ie \\> 180° arterial encasement (SMA and CA) unreconstructible venous encasement (SMV\u002FPV) due to tumor involvement or occlusion of a long segment.\n* CA 19.9 \\> 2500 kU\u002Fl (baseline and absence of cholestasis)\n* Contraindication of surgery (general)\n* Contraindications to receive FFX or gemcitabine-nab-Paclitaxel\n* History of radiotherapy of the upper abdomen\n* Prior treatment with oxaliplatin, irinotecan, fluoruouracil or capecitabin\n* Patient \\\u003C 18 years old\n* Major surgery within 4 weeks of study entry\n* Uncontrolled pre-existing disease including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina, social \u002F psychiatric disorder that would limit compliance to treatment and good understanding of the informed consent form\n* Other concurrent anticancer therapies\n* Existence of another active neoplasia other than basal cell carcinoma of the skin, cervical carcinoma in situ or non-metastatic prostate cancer. Patients who have a history of neoplasia must have been in remission for more than 5 years to be included in the protocol\n* Pregnant or breastfeeding women; for women of childbearing potential only, a negative pregnancy test done \\\u003C 7 days prior to registration is required. Using of reliable contraception for at least 1 month before treatment is mandatory\n* Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3, subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study\n\nAdditional exclusion criteria before randomisation:\n\n* Progressive disease (RECIST or PETCT, including non locoregional nodal involvement and increase of CA 19.9 by 20%) after receiving 4 cycles of FFX (or G\u002FNP), including shift chemotherapy in case of early progression.\n* CA 19.9 \\> 1000 kU\u002Fl after neoadjuvant therapy.\n* Presence of unmanageable toxicity during the first part of neoadjuvant chemotherapy (first 4 cycles or 6 doses of FFX or G\u002FNP, respectively.\n* Pancreatic tumour \\> 7.0 cm in greatest axial dimension at the time of randomization\n* Massive invasion of the stomach or intestines and\u002For direct intestinal invasion of the mucosae visible at ultrasoundendoscopy\n* Active gastric or duodenal ulcer disease at the time of randomization. Tolerated in case of antecedent without active ulcer (confirmation by endoscopy before iHD-SBRT)",{"count":206,"type":20},256,[53],"Surgical resection is the only potentially curative treatment for patients with pancreatic cancer with the aim of curative R0 resection and related improvement of survival. As a standard, surgery is usually followed by adjuvant therapy that improves survival but neoadjuvant therapy (NAT) is a rapidly emerging concept that needs to be explored and validated in terms of therapeutic options in borderline resectable pancreatic tumors. In this setting, preoperative FFX seems to be feasible and can be prolonged by radiation therapy. However, the exact and best therapeutic sequence is not yet known and the additional role of adding isotoxic high-dose stereotactic body radiotherapy (iHD-SBRT) to chemotherapy requires validation in randomised trials. We propose to evaluate the impact and efficacy of adding iHD-SBRT to preoperative neoadjuvant mFFX or Gem-NabP in patients with borderline resectable pancreatic adenocarcinoma.",[210,211,27],"Pancreatic Neoplasm","Pancreatic Adenocarcinoma",[163,105,213,157],"stereotactic body radiation therapy","2023-05-22",{"date":216,"type":34},"2023-05-23",{"date":218,"type":34},"2023-03-24",{"date":113,"type":20},{"name":221,"class":65},"Erasme University Hospital",10,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":185,"phases":4,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":66},"100466615","survival-quality-of-life-and-resectability-in-locally-advanced-pancreatic-cancer-100466615","NCT05356039","Survival, Quality of Life and Resectability in Locally Advanced Pancreatic Cancer","Survival, Quality of Life and Resectability in Locally Advanced Pancreatic Cancer - a Multicenter Prospective Observational Study","SQUARE","Inclusion Criteria:\n\n* Confirmed or suspected invasive pancreatic primary tumor\n* Tumor classified as borderline resectable or locally advanced disease according to NCCN guidelines\n\nExclusion Criteria:\n\n* Suspected endocrine tumor\n* Suspected non-pancreatic periampullary tumor\n* Distant metastasis\n* Age \\\u003C 18 years\n* Patient unable to understand verbal or written information interfering with informed consent or treatment\n* Mental or organic disorder interfering with informed consent or treatments",{"count":232,"type":20},300,"This study aims to assess overall survival, quality of life and resection rates in locally advanced pancreatic cancer",[235,236,237,79,238,239,240,28,27],"Pancreas Cancer","Pancreas Neoplasm","Pancreas Disease","Surgery","Chemotherapy Effect","Quality of Life","2022-11-23",{"date":243,"type":34},"2022-11-30",{"date":245,"type":34},"2022-04-19",{"date":247,"type":20},"2028-05",{"name":249,"class":65},"Umeå University"]