[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"borderline-resectable-pancreatic-ductal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:borderline-resectable-pancreatic-ductal-adenocarcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,42,67,79,107,131,152,176,200,227],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053814","phase-1-samuraciclib-for-the-treatment-of-patients-with-resectable-borderline-resectable-or-locally-advanced-basal-pancreatic-cancer-100053814",false,"NCT07645651","Samuraciclib for the Treatment of Patients With Resectable, Borderline Resectable, or Locally Advanced Basal Pancreatic Cancer","Phase 1b Window-of-Opportunity Study Evaluating CDK7 Inhibition in Patients With Localized Basal Pancreatic Cancer","Inclusion Criteria:\n\n* Histologically or cytologically proven basal pancreatic adenocarcinoma. Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible.\n\n  * Basal tumors are defined as GATA6- and HMGA2+. Tumor cores are considered positive for GATA6 or HMGA2 if greater than 10% of tumor epithelial cells had positive nuclei\n* Resectable, borderline resectable, or locally advanced pancreatic ductal adenocarcinoma (PDA) at diagnosis based on contrast-enhanced CT or magnetic resonance imaging (MRI) (CT or MRI without contrast as part of positron emission tomography (PET)\u002FCT or PET\u002FMRI is NOT acceptable; CT or MRI with contrast as part PET\u002FCT or PET\u002FMRI is acceptable) of the chest, abdomen, and pelvis. The institutional radiologist must review the scans. Resectable, borderline resectable, and locally advanced will be defined by National Comprehensive Cancer Network (NCCN) guidelines version 2.2025.\n\n  * There must be no evidence of metastatic disease\n* Must be 18 years or older\n* Ability to understand and willingness to sign a written informed consent document\n* Archival biopsy specimen collected within 3 months must be available. If not available, a diagnostic EUS\u002FFNB will be performed during screening\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL (within 14 days prior to study drug)\n* Platelets ≥ 100,000\u002FmcL (within 14 days prior to study drug)\n* Hemoglobin ≥ 9 g\u002FdL (within 14 days prior to study drug)\n* Serum creatinine ≥ 1.5X upper limit of normal (ULN) or serum creatinine clearance ≥ 50 ml\u002Fmin by Cockcroft-Gault (within 14 days prior to study drug)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤ 2.5X ULN (within 14 days prior to study drug)\n* Total bilirubin ≤ 1.5X ULN (within 14 days prior to study drug)\n* Participants must not be pregnant or nursing. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test within 72 hours of treatment initiation, where WOCBP are defined as all female participants between 18 - 55 years of age. Participants of child-bearing potential must be willing to employ two highly effective and acceptable forms of contraception for up to 6 months after the final administered dose of investigational agent. A woman is considered to be of reproductive potential if she has had menses at any time in the preceding 12 consecutive months\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n\nExclusion Criteria:\n\n* Prior radiation\n* Unable to tolerate oral medication, per assessment of the principal investigator (PI)\n* Participants who are receiving other investigational agents\n* Concomitant mediation use should only exclude patients from trial participation when clinically relevant known or predicted drug-drug interactions or potential overlapping toxicities will impact safety or efficacy\n* Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection with clinically significant sequelae that precluded adequate absorption of samuraciclib\n* Uncontrolled seizures\n* Active infection\n* Active bleeding diatheses\n* Known active hepatitis B or hepatitis C infection\n* Breastfeeding or pregnancy\n* Receipt of systemic corticosteroids within 14 days before the first dose of study medication\n* Receipt of St. John's Wort within 21 days before the first dose of study medication or of another concomitant medication, herbal supplement, or food that was a strong inhibitor or inducer of CYP3A4, CYP2C19, CYP2D6, or P-glycoprotein activity within 21 days before the first dose of samuraciclib\n* Known hypersensitivity to samuraciclib or any excipient of the product","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to evaluate the safety and efficacy of samuraciclib in patients with localized pancreatic cancer.",[26,27,28],"Resectable Pancreatic Ductal Adenocarcinoma","Borderline Resectable Pancreatic Ductal Adenocarcinoma","Locally Advanced Pancreatic Ductal Adenocarcinoma","NOT_YET_RECRUITING","2026-07-09",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":20},"2026-10-01",{"date":37,"type":20},"2027-11-01",{"name":39,"class":40},"University of Washington","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100642918","phase-2-personalize-signature-driven-neoadjuvant-chemotherapy-trial-for-patients-with-resectable-borderline-pancreatic-ductal-adenocarcinoma-100642918","NCT07616362","Personalize (Signature Driven) Neoadjuvant Chemotherapy Trial for Patients With Resectable Borderline Pancreatic Ductal Adenocarcinoma.","a Multicenter Phase II Trial Using Transcriptomic Signatures to Personalize Neoadjuvant Chemotherapy for Patients With Resectable Borderline Pancreatic Ductal Adenocarcinoma.","NEOPREDICT","Inclusion Criteria:\n\n* Borderline resectable pancreatic ductal adenocarcinoma (BR-PDAC) defined by National Comprehensive Cancer Network (NCCN) criteria v2.2025 on contrast-enhanced CT-scan (including non-contrast acquisition, pancreatic phase and portal venous phase), with stage confirmed by a local pancreatic expert review board including at least medical oncologist\u002Fonco-gastroenterologist, pancreatic surgeon and pancreatic expert radiologist. No central review is required,\n* Measurable pancreatic lesion according to RECIST 1.1 (CT scan or MRI \\\u003C 28 days),\n* WHO PS 1 or 0,\n* Histologically proven pancreas ductal adenocarcinoma,\n* Available FFPE from pancreatic tumor sample with \\> 10% of tumor cells (assessed by a local expert pancreatic pathologist),\n* No prior chemotherapy or radiation for pancreatic cancer (except one cycle of mFOLFIRINOX during waiting time for GEM + signature) or resection of pancreatic cancer,\n* Age ≥18 years old and ≤ 80 years old if geriatric standardized evaluation validates the study chemotherapy regimen administration for patients between 75-80,\n* Written informed consent obtained from patient before any protocol related intervention,\n* Acceptation and ability to conform to the protocol requirement during all the duration of the investigation including treatment, scheduled visits, clinical and biological examinations and follow up,\n* Adequate organ function, as defined by the following:\n* AST and ALT \\\u003C 3.5 x upper limit of normal (ULN),\n* Total serum bilirubin \\\u003C 3 x ULN, (for patients with total serum bilirubin between 1.5 and 3 x ULN, the dose of irinotecan will be adjusted in accordance with the SmPC).\n* Serum albumin \\>30 g\u002FL,\n* Hemoglobin \\>9.0 g\u002Fdl,\n* Absolute neutrophil count (ANC) \\>1.5 G\u002FL,\n* Platelets \\>100 G\u002FL,\n* Creatinine clearance \\> 50 mL\u002Fmin (according to CKD-EPI),\n* Normal Kalemia, calcemia, magnesemia\n* Women of childbearing potential must agree to use contraception during treatment and for at least 15 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 12 months after discontinuation of the experimental treatments.\n* Patient affiliated to French social security\n\nExclusion Criteria:\n\n* Strictly resectable or locally advanced PDAC according to NCCN criteria,\n* Distant metastases (including inter aortic lymph nodes),\n* Any condition that contraindicates the use of IRINOTECAN, OXALIPLATIN, 5FU, GEMCITABINE or NAB-PACLITAXEL,\n* Partial or complete DPD deficiency (uracilemia ≥ 16 ng\u002FmL),\n* Any progressive pathology not stabilized over the past 6 months: liver impairment, renal impairment, respiratory or cardiac failure.\n* Other concomitant cancer or a history of cancer during the previous 3 years, except for localized cancer in situ, basal or squamous cell skin cancer adequately treated,\n* Other interventional clinical trial except for non-interventional trial (ie not modifying 1-year EFS),\n* QT\u002FQTc (Fredericia Correction) interval \\> 450 msec for men and \\> 460 msec for women,\n* Pregnant or breastfeeding woman,\n* Known Gilbert's syndrome or known homozygosity for UGAT1A1\\*28 polymorphism,\n* Treatment with millepertuis,\n* Uncompensated asthma,\n* Potentially severe infection \\\u003C 7 days,\n* Inflammatory bowel disease and\u002For intestinal obstruction,\n* Known severe allergy to contrast dye (for CT or MRI) without possible substitution,\n* Hypersensitivity to the active substance or to one of the excipients of one of the study treatments,\n* Treatment with brivudine within 4 weeks prior to the administration of protocol treatment,\n* Concomitant treatment with a strong inhibitor (i.e. ketoconazole) or inducer (i.e. rifampicin, carbamazepine, phenobarbital, phenytoin, apalutamide) of cytochrome P450 3A4 or 2C8 (CYP3A4 or CYP2C8),\n* Patient who has received a live attenuated vaccine (against yellow fever, chickenpox, shingles, measles, mumps, rubella, tuberculosis, rotavirus) in the 6 weeks prior to randomization,\n* Patient with sensitive peripheral neuropathy with functional discomfort,\n* Impossibility of undergoing medical monitoring during the trial for geographical, social, or psychological reasons,\n* Patient who is under judicial protection (patient who is legally institutionalized or under guardianship or curatorship) or not able to give consent. (as refered at art. art. L. 1121-6, art. L. 1121-8, art. L. 1121-8-1 du Code de la Santé Publique)","80 Years",{"count":52,"type":20},110,[54],"PHASE2","Pancreatic ductal adenocarcinoma (PDAC) exhibits significant heterogeneity, making the optimal choice of chemotherapy challenging. While targeted therapies benefit from companion biomarkers, few tools exist to guide the selection of cytotoxic chemotherapy. Transcriptomic signatures now allow for the prediction of sensitivity to cytotoxic agents. Several molecular classifications (such as basal-like, classical, etc.) have been established and correlated with prognosis, but they are rarely used in clinical practice. The PaCaOmics program has developed robust predictive signatures, grouped under the name Pancreas-View Signature, capable of analyzing FFPE samples using minimal material.\n\nLocally advanced or borderline resectable pancreatic cancer (BR-PDAC) accounts for approximately 20% of cases. Neoadjuvant chemotherapy (NAC) has become the standard of care, improving R0 resection rates and overall survival. The two main chemotherapy regimens used are mFOLFIRINOX and GEM\u002FNAB-paclitaxel, which show comparable efficacy and toxicity profiles. However, no clear consensus exists on the superiority of one over the other. Therefore, predictive biomarkers are crucial to help select the most appropriate neoadjuvant regimen, avoid unnecessary toxicities, and maximize the chances of curative surgery. The NEOPREDICT trial aims to evaluate the efficacy of treating patients with borderline resectable PDAC identified with a GEM+ sensitivity transcriptomic signature with GEMCITABINE + NAB-PACLITAXEL regimen compared to standard of care mFOLFIRINOX as NAC.",[27],"2026-06-09",{"date":59,"type":33},"2026-06-11",{"date":61,"type":20},"2026-06",{"date":63,"type":20},"2031-04",{"name":65,"class":40},"Federation Francophone de Cancerologie Digestive",5,{"id":68,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":24,"conditions":71,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":78,"locationsCount":41},"100643239",{"count":19,"type":20},[23],[26,27,28],"2026-06-08",{"date":74,"type":33},"2026-06-12",{"date":76,"type":20},"2026-07-01",{"date":37,"type":20},{"name":39,"class":40},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":41},"100637571","phase-1-ab801-in-combination-with-chemotherapy-and-immunotherapy-for-the-treatment-of-patients-with-borderline-resectable-locally-advanced-or-metastatic-cholangiocarcinoma-or-pancreatic-cancer-100637571","NCT07619313","AB801 in Combination With Chemotherapy and Immunotherapy for the Treatment of Patients With Borderline Resectable, Locally Advanced or Metastatic Cholangiocarcinoma or Pancreatic Cancer","A Phase 1\u002F1b Trial of AB801 in Combination With Chemotherapy and PD-1\u002FPD-L1 Blockade in Patients With Cholangiocarcinoma or 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, at least one measurable lesion via Response Evaluation Criteria in Solid Tumors (RECIST 1.1) of cholangiocarcinoma or pancreatic adenocarcinoma meeting following criteria:\n\n  * Cholangiocarcinoma\n\n    * Borderline resectable\u002Flocally advanced cholangiocarcinoma: to be defined as unresectable disease on evaluation by a hepatobiliary multi-disciplinary tumor board\u002Fsurgeon based on tumor size\u002Flocation, vascular involvement, and absence of extrahepatic metastasis.\n    * Metastatic cholangiocarcinoma: Patients with metastatic cholangiocarcinoma patient who have not received prior systemic therapy\n  * Pancreatic adenocarcinoma\n\n    * Borderline resectable pancreatic adenocarcinoma: There are multiple definitions of borderline resectable pancreatic ductal adenocarcinoma (PDAC). For the purposes of this study, borderline resectable disease will be identified per the National Comprehensive Cancer Network (NCCN) criteria. Per this definition, borderline resectable PDAC is defined as the presence of any one or more of the following on CT:\n\n      * An interface between the tumor and superior mesenteric artery (SMA) or celiac axis (CA) measuring \\\u003C 180º of the circumference of the vessel wall.\n      * An interface between the tumor with the common hepatic artery without extension into the celiac axis or hepatic artery bifurcation allowing for safe and complete resection and reconstruction.\n      * An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring ≥ 180° 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      * An interface between the primary tumor and the inferior vena cava (IVC)\n    * Locally advanced pancreatic adenocarcinoma: Multiple guidelines defining locally advanced PDAC have been developed. For the purposes of this study, locally advanced PDAC cases will be identified per the definition developed by the NCCN. Per this definition, locally advanced PDAC is defined as presence of any one or more of the following on CT:\n\n      * Interface between the tumor and SMA or CV measuring \\> 180º of the circumference of the vessel wall or solid tumor contact with the CA and aortic involvement.\n      * Occlusion of the SMV-PV that is not amenable to resection and venous reconstruction\n  * Metastatic pancreatic adenocarcinoma: Patients with metastatic pancreatic adenocarcinoma who have not received prior systemic therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Absolute neutrophil count (ANC) ≥ 1.5x10\\^9\u002FL\n* Platelets ≥ 100x10\\^9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n* Creatinine clearance (Ccr) ≥ 50 mL\u002Fmin (as calculated by Modified Cockcroft-Gault formula)\n* Serum total bilirubin ≤ 2x upper limit of normal (ULN) or \\\u003C 3x ULN if Gilbert's syndrome\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 2.5 X ULN; \\\u003C 5x ULN in patients with liver metastases\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, OR\n* Women of childbearing potential (defined as any female who has experienced menarche and is not permanently sterile or post-menopausal) 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) or practice true abstinence for the duration of the study and for up to 14 months after the last systemic treatment\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) or practice true abstinence as defined throughout the study and for up to 11 months after the systemic treatment\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 (≤ 10 mg\u002Fday of prednisone or its equivalent) or short pulses of corticosteroids (≤ 3 days) may be permitted\n* Products with known potential to prolong the corrected QT (QTc) interval should be avoided when possible. When able will replace non-prolonging QTc acting drug when available and if medically necessary\n* Major surgery as defined by the Investigator must be completed at least 4 weeks before study treatment administration. Participants should have recovered from the surgical procedure prior to the first dose being administered\n* Adequate baseline tumor tissue sample for correlative studies\n\nExclusion Criteria:\n\n* Previous treatment with any of planned study drugs in cholangiocarcinoma, though patients with one cycle of gemcitabine\u002Fcisplatin\u002Fdurvalumab will be considered eligible\n* Previous treatment with any of planned study drugs in pancreatic adenocarcinoma, though patients with one cycle of FOLFIRINOX will be considered eligible\n* Peripheral neuropathy \\> grade 2\n* Known status of HIV which is not well-controlled (CD4 \\\u003C 300) 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 known active or known history of infection or 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 opinion, will make the administration of investigational product (IP)(s) hazardous, including but not limited to:\n\n  * Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis\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  * 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* Any history of malignancy less than 5 years prior to the time of study eligibility (Patients with history of skin cancers excluding melanoma and cancers with a very low risk of recurrence i.e., low grade prostate cancer, thyroid cancer and low risk cervical cancer 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 family history or personal history of long QTc syndrome or previous drug-induced QTc prolongation of at least grade 3 (QTc \\> 500 ms)\n* Screening 12-lead electrocardiogram (ECG), in triplicate, with a measurable QTc interval of \\> 450ms\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 childbearing potential (WOCBP): Negative serum pregnancy test at screening and serum or urine 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 human chorionic gonadotropin \\[HCG\\]). WOCBP must also have a negative serum or urine pregnancy test every 3 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",{"count":87,"type":20},46,[23],"This phase I trial tests the safety, side effects, best dose and effectiveness of AB801 in combination with chemotherapy and immunotherapy in treating patients with cholangiocarcinoma or pancreatic adenocarcinoma that may be removed by surgery (borderline resectable), that has spread to nearby tissue or lymph nodes (locally advanced), or that has spread from where it first started (primary site) to other places in the body (metastatic). AB801 is a drug designed to block a protein called AXL. AXL is found on the surface of certain cancer cells and plays an important role in helping tumors grow, spread to other parts of the body, and avoid the immune system. It is thought to contribute to resistance against common cancer treatments such as chemotherapy, radiation and immunotherapy. In many cancers, including cholangiocarcinoma and pancreatic adenocarcinoma, AXL is overactive and associated with worse outcomes. AB801 inhibits AXL which may make cancer cells more sensitive to chemotherapy and allow immune cells to better recognize and attack the tumor. Chemotherapy drugs, such as gemcitabine, cisplatin, oxaliplatin, irinotecan, leucovrin 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. Immunotherapy with monoclonal antibodies, such as durvalumab and zimberelimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving AB801 in combination with chemotherapy and immunotherapy may better treat patients with borderline resectable, locally advanced or metastatic cholangiocarcinoma or pancreatic adenocarcinoma.",[27,91,92,93,94,95,96,97],"Locally Advanced Cholangiocarcinoma","Locally Advanced Pancreatic Adenocarcinoma","Metastatic Cholangiocarcinoma","Metastatic Pancreatic Adenocarcinoma","Stage II Pancreatic Cancer AJCC v8","Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","2026-06-02",{"date":100,"type":33},"2026-06-04",{"date":102,"type":20},"2026-06-01",{"date":104,"type":20},"2028-06-01",{"name":106,"class":40},"Jonsson Comprehensive Cancer Center",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":41},"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":115,"type":20},36,[54],"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.",[27,119,120,95,96],"Resectable Pancreatic Adenocarcinoma","Stage I Pancreatic Cancer AJCC v8","RECRUITING","2026-04-17",{"date":124,"type":33},"2026-04-22",{"date":126,"type":33},"2024-08-06",{"date":128,"type":20},"2027-12-31",{"name":130,"class":40},"Emory University",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":41},"100579261","phase-2-nalirifox-before-surgery-for-the-treatment-of-borderline-resectable-pancreatic-ductal-adenocarcinoma-nectar-trial-100579261","NCT06821997","NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial","A Phase 2 Clinical Trial of Nalirifox as Neoadjuvant Treatment for Patients With Borderline Resectable Pancreatic Ductal Adenocarcinoma (Nectar Study)","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) that is borderline resectable (BR) using the National Comprehensive Cancer Network criteria\n* Have a documented Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002FuL without the use of hematopoietic growth factors\n* Platelet count ≥ 100,000 cells\u002FuL\n* Hemoglobin ≥ 9 g\u002FdL\n* Plasma total bilirubin ≤ upper limit of normal (ULN) (biliary drainage is allowed for biliary obstruction)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Creatine clearance of \\> 30 mL\u002Fmin (per Cockroft-Gault equation)\n* Plasma albumin ≥ 3 g\u002FdL\n* Have measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form (ICF) prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Patients who have had previous chemotherapy or radiotherapy for PDAC\n* Patients with resectable, unresectable, or metastatic PDAC\n* Presence of germline glucuronosyltransferase (UGT) 1A1 (\\*28 or \\*6) or dihydropyrimidine dehydrogenase (DPD) polymorphisms (DPYD\\*2A \\[rs3918290, c.1905+1G\\>A, IVS14+1G\\>A\\], c.2846A\\>T \\[rs67376798, D949V\\], c.1679T\\>G \\[rs55886062, DPYD\\*13, I560S\\], and c.1236G\\>A \\[rs56038477, E412E, in haplotype B3\\]) known to significantly impact CPT-11 and fluorouracil metabolism and associated with increased risk for toxicities\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug",{"count":139,"type":20},20,[54],"This phase II trial tests how well liposomal irinotecan, oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) before surgery works in treating patients with pancreatic ductal adenocarcinoma that is close to major blood vessels, but is still potentially removable by surgery (borderline resectable). Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Liposomal irinotecan is a form of the anticancer drug irinotecan that is contained inside very tiny, fat-like particles. Liposomal irinotecan may have fewer side effects and work better than other forms of the drug. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. 5-fluorouracil, a type of antimetabolite, stops cells from making DNA and it may kill tumor cells. Leucovorin, a form of folic acid, is used to lessen the toxic effects of substances that block the action of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Giving NALIRIFOX before surgery may improve the chance of successful surgery and decrease the chance of the cancer returning after surgery in patients with borderline resectable pancreatic ductal adenocarcinoma.",[27],"2026-03-31",{"date":145,"type":33},"2026-04-01",{"date":147,"type":33},"2026-03-02",{"date":149,"type":20},"2027-03-01",{"name":151,"class":40},"Roswell Park Cancer Institute",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":41},"100362937","early-phase-1-targeted-pathway-inhibition-in-patients-with-pancreatic-cancer-100362937","NCT04005690","Targeted Pathway Inhibition in Patients With Pancreatic Cancer","A Window of Opportunity Strategy for Targeted Pathway Inhibition in Patients With Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Clinically-confirmed diagnosis of resectable, borderline resectable, locally-advanced or metastatic adenocarcinoma of the pancreas.\n\n  * Patients with disease that is eligible for curative surgery may not be eligible for all study arms.\n  * Participants may be treatment naïve or have received prior therapy for the treatment of their pancreatic ductal adenocarcinoma (PDAC). A minimum washout period of 10-days after completing the most recent line of therapy is required before a participant can initiate treatment with study agent(s)\n* Based on available imaging, participant must have at least one disease lesion that can be biopsied in accordance with institutional standards\n* Hemoglobin \\>= 9.0 g\u002FdL with no blood transfusion within 28 days of starting treatment (within 4 weeks prior to initiating window treatment). Note: laboratory tests performed after initial screening (but still within the screening window) will be evaluated by the investigator; should any of these values fall outside eligibility parameters, the patient may still be eligible per investigator discretion\n* White blood cells (WBC) \\> 3 x 10\\^9\u002FL (within 4 weeks prior to initiating window treatment). Note: laboratory tests performed after initial screening (but still within the screening window) will be evaluated by the investigator; should any of these values fall outside eligibility parameters, the patient may still be eligible per investigator discretion\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (\\> 1500 per mm\\^3) (within 4 weeks prior to initiating window treatment). Note: laboratory tests performed after initial screening (but still within the screening window) will be evaluated by the investigator; should any of these values fall outside eligibility parameters, the patient may still be eligible per investigator discretion.\n\n  * May be waived on a case-by-case basis for patient populations recognized to have normal baseline values below this level\n* Platelet count \\>= 100 x 10\\^9\u002FL (\\> 100,000 per mm\\^3) (within 4 weeks prior to initiating window treatment). Note: laboratory tests performed after initial screening (but still within the screening window) will be evaluated by the investigator; should any of these values fall outside eligibility parameters, the patient may still be eligible per investigator discretion\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN), OR measured or calculated creatinine clearance (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) \\>= 60 mL\u002Fmin\u002F1.73m\\^2 for participants with creatinine levels \\> 1.5 x institutional ULN (within 4 weeks prior to initiating window treatment). Note: laboratory tests performed after initial screening (but still within the screening window) will be evaluated by the investigator; should any of these values fall outside eligibility parameters, the patient may still be eligible per investigator discretion.\n\n  * Creatinine clearance should be calculated per institutional standard. For participants with a baseline calculated creatinine clearance below normal institutional laboratory values, a measured baseline creatinine clearance should be determined. Individuals with higher values felt to be consistent with inborn errors of metabolism will be considered on a case-by-case basis\n* Serum bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (within 4 weeks prior to initiating window treatment). Note: laboratory tests performed after initial screening (but still within the screening window) will be evaluated by the investigator; should any of these values fall outside eligibility parameters, the patient may still be eligible per investigator discretion\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x ULN (within 4 weeks prior to initiating window treatment). Note: laboratory tests performed after initial screening (but still within the screening window) will be evaluated by the investigator; should any of these values fall outside eligibility parameters, the patient may still be eligible per investigator discretion\n* Participants must be willing to undergo mandatory on-study tumor biopsies\n* Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* Participant must be able to swallow tablets or capsules. A participant with any gastrointestinal disease that would impair ability to swallow, retain, or absorb drug is not eligible\n* Participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Participants must agree to use an adequate method of contraception starting with the first dose of study therapy and for the required length of time ascribed to the assigned study drug assignment\n* No other prior invasive malignancy is allowed except for the following: adequately treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer, any malignancy treated with a curative intent without evidence of disease recurrence for at least 6 months\n* Individuals must not have known active hepatitis B virus (HBV). Those who have completed curative therapy for hepatitis C virus (HCV) are eligible. HCV infection permitted but patient must be Child's Pugh A. Patients with known human immunodeficiency virus (HIV) infection are eligible if they meet all of the following 3 criteria:\n\n  * CD4 counts \\>= 350 mm\\^3\n  * Serum HIV viral load of \\\u003C 25,000 IU\u002Fml and\n  * Treated on a stable antiretroviral regimen\n  * Note: HIV testing is not required at screening, unless if required by local regulations, where the testing will be done by local laboratory\n* AZENOSERTIB SPECIFIC CRITERIA: Those with prior treatment with a WEE1 inhibitor are not eligible\n* AZENOSERTIB SPECIFIC CRITERIA: Patients are not eligible if any of the following treatment interventions have occurred within the specified time frame(s) prior to starting study intervention:\n\n  * Major surgery within 28 days (the surgical incision should be fully healed prior to study drug administration)\n  * Radiation therapy within 21 days; however, if the radiation portal covered ≤ 5% of the bone marrow reserve, the subject is eligible irrespective of the end date of radiotherapy\n  * Autologous or allogeneic stem cell transplant within 3 months\n  * Current use of an investigational agent that is not expected to be cleared by the first dosing of study drug or that has demonstrated to have prolonged side effects\n  * Prescription, non-prescription drugs or food known as moderate to strong inducers of CYP3A within 2 weeks\n* AZENOSERTIB SPECIFIC CRITERIA: Patients are not eligible if there is a serious illness or medical condition(s) including, but not limited to, the following:\n\n  * Symptomatic brain metastases\n  * Leptomeningeal disease that requires or is anticipated to require immediate treatment.\n  * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the subject inappropriate for entry into this study\n  * Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for IV alimentation, active peptic ulcer, chronic diarrhea or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption\n  * Active or uncontrolled infection. Subjects with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ≥ 72 hours\n* AZENOSERTIB SPECIFIC CRITERIA: 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of \\>480 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid\n* AZENOSERTIB SPECIFIC CRITERIA: History or current evidence of congenital or family history of long QT syndrome or Torsade de Pointes\n* AZENOSERTIB SPECIFIC CRITERIA: Patients are not eligible in cases of unresolved toxicity of grade \\> 1 attributed to any prior therapies (excluding grade 2 neuropathy, alopecia or skin pigmentation)\n* AZENOSERTIB SPECIFIC CRITERIA: Patients are not eligible if there is known hypersensitivity to any drugs similar to ZN-c3 in class\n* AZENOSERTIB SPECIFIC CRITERIA: Individuals that are pregnant or breast-feeding are not eligible\n* AZENOSERTIB SPECIFIC CRITERIA: Participants must agree to use an adequate method of contraception as follows:\n\n  * Participants of childbearing potential agree to use adequate methods of contraception for the duration of study participation.\n  * Sperm-producing participants must agree to refrain from sperm donation during the study and for 30 days after the last dose of study drug\n* AZENOSERTIB SPECIFIC CRITERIA: Participant requiring any medications that can lead to significant QT prolongation are not eligible\n* AZENOSERTIB SPECIFIC CRITERIA: Participant requires administration of strong and moderate CYP3A4 inhibitors and inducers as well as strong and moderate P-glycoprotein (P-gp) inhibitors are not eligible\n* AZENOSERTIB SPECIFIC CRITERIA: Due to potential CYP3A4 interaction with the study medication, participants are asked to refrain from consumption of seville oranges, grapefruit or grapefruit juice, ppomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices) from 7 days prior to the initiating study agent and during the entire study. NOTE: Orange juice is permitted\n* AZD5305 SPECIFIC CRITERIA: Participants must agree to use an adequate method of contraception as follows:\n\n  * Participants of childbearing potential must agree to use adequate methods of contraception starting with the first dose of study therapy through at least 6 months after the last dose of study therapy\n  * Sperm-producing participants must use a condom during treatment and for 6 months after the last dose of AZD5305 when having sexual intercourse with an individual that is pregnant or of childbearing potential. Individuals that are partners of sperm-producing participants should also use a highly effective form of contraception if they are of childbearing potential\n* TREMELIMUMAB SPECIFIC CRITERIA: Participants of childbearing potential must agree to use adequate methods of contraception starting with the first dose of study therapy through at least 3 months after the last dose of study therapy\n\nExclusion Criteria:\n\n* Tumor not accessible for core biopsy\n* Medical co-morbidities that are deemed to make risk of surgery unacceptably high as determined by institutional standards\n* Recent major surgery within 4 weeks prior to starting study treatment. Minor surgery within 2 weeks of starting study treatment. Patients must be recovered from effects of surgery\n* Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil)\n* Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil)\n* Concomitant use of other anti-cancer therapy (chemotherapy, immunotherapy, hormonal therapy (hormone replacement therapy is acceptable), radiotherapy (except for palliative), biological therapy or other novel agent) or live virus and live bacterial vaccines while the patient is receiving study medication. Strong or moderate CYP3A inhibitors and inducers should not be taken with study treatment; however, if no other suitable alternative concomitant medication is available, dose reductions may be allowed under careful monitoring\n* Known severe hypersensitivity to the study agent(s) (or equivalent agents, respectively), or any excipient of these medicinal products, or history of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent(s)\n* Clinically significant cardiac disease or impaired cardiac function, including any of the following:\n\n  * Clinically significant and\u002For uncontrolled heart disease such as congestive heart failure (New York Heart Association grade \\>= 2) uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment\n  * Corrected QT using Fridericia's formula (QTcF) \\> 470 msec for females, or \\> 450 msec for males, on screening electrocardiogram (ECG) or congenital long QT syndrome\n  * Acute myocardial infarction or unstable angina pectoris \\\u003C 6 months prior to screening\n* Clinically significant cardiac disease or impaired cardiac function\n* Female participant who is pregnant or lactating\n* Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally\n* Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment)\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Participants with a history of hypersensitivity reactions to study agents or their excipients\n* Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through at least 120 days after the last dose of trial treatment\n* AZD5305 SPECIFIC CRITERIA: Known allergy or hypersensitivity to AZD5305 or any of its excipients\n* AZD5305 SPECIFIC CRITERIA: Patients with myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML\n* AZD5305 SPECIFIC CRITERIA: Cardiovascular disease, QTc \\> 450 ms, or any factors that increase the risk of QTc prolongation or risk of arrhythmic events\n* AZD5305 SPECIFIC CRITERIA: History of persisting (\\> 2 weeks) severe pancytopenia due to any cause (ANC \\\u003C 0.5 x 10\\^9\u002FL or platelets \\\u003C 50 x 10\\^9\u002FL)\n* TREMELIMUMAB SPECIFIC CRITERIA: Medical co-morbidities that are deemed to make risk of surgery unacceptably high as determined by institutional standards\n* TREMELIMUMAB SPECIFIC CRITERIA: Participants have received prior immunotherapy for the treatment of their PDAC\n* TREMELIMUMAB SPECIFIC CRITERIA: Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) \\> grade 2 from prior neoadjuvant therapy\n* TREMELIMUMAB SPECIFIC CRITERIA: History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, interstitial lung disease (ILD), pleural effusion, or pulmonary fibrosis diagnosed in the past 6 months prior to randomization\n* TREMELIMUMAB SPECIFIC CRITERIA: Active or prior documented autoimmune or inflammatory disorders",{"count":160,"type":20},90,[162],"EARLY_PHASE1","This early phase I trial aims to determine how cobimetinib, olaparib, onvansertib, azenosertib, AZD5305 or tremelimumab works in patients with pancreatic cancer. Validation of cobimetinib, olaparib, onvansertib azenosertib, AZD5305 and tremelimumab molecular targets will be explored by comparing pre-treatment biopsies with post-treatment specimens. This knowledge will help design future biomarker driven trials to determine whether giving cobimetinib, or olaparib, or onvansertib or azenosertib, or AZD5305, or tremelimumab will work better than standard treatments in patients with pancreatic cancer.",[28,165,95,96,97,166,27,26],"Metastatic Pancreatic Ductal Adenocarcinoma","Unresectable Pancreatic Ductal Adenocarcinoma","2026-02-26",{"date":169,"type":33},"2026-02-27",{"date":171,"type":33},"2019-08-01",{"date":173,"type":20},"2028-02-01",{"name":175,"class":40},"OHSU Knight Cancer Institute",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":41},"100560244","using-tumour-dna-and-proteins-to-better-understand-how-pancreatic-cancer-responds-to-treatment-100560244","NCT06574620","Using Tumour DNA and Proteins to Better Understand How Pancreatic Cancer Responds to Treatment","Accelerating the Actionability of Treatment in Resected and Locally Advanced Pancreatic Cancer","ACCELERATE","Inclusion Criteria:\n\nParticipants must meet all of the following criteria prior to Pre-Baseline registration:\n\n1. Age 18 years or older.\n2. Histological or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC.\n3. Medically fit and planned to undergo laparoscopic procedure as part of standard of care.\n4. Able to give informed consent for the study-related procedures performed during laparoscopy.\n\nParticipants must meet all of the following criteria to be eligible for enrollment in the Main Study:\n\n1. Age 18 years or older.\n2. Enrolled in the Personalized Oncogenomics (POG) Program at BC Cancer.\n3. Histological and\u002For radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC. Participants without a histological diagnosis of PDAC must undergo confirmatory histological diagnosis prior to treatment start date.\n4. Medically fit to undergo surgical resection of the primary lesion(s) as judged by the investigator (Resectable and Borderline Resectable Cohorts only).\n5. Planned for adjuvant (Resectable and Borderline Resectable Cohorts) or first-line (Locally Advanced Cohort) therapy with FOLFIRINOX or a gemcitabine-based regimen, either as part of routine care or in combination with an investigational agent(s) within another clinical trial. Participants may have received pre-operative therapy.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n7. Adequate organ function as defined by the following laboratory results obtained within 28 days prior to enrollment date:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL.\n   2. Hemoglobin ≥ 9 g\u002FdL.\n   3. Platelets ≥ 75 x 10\\^9\u002FL.\n   4. Prothrombin time test and international normalized ratio (PT\u002FINR) and partial thromboplastin time (PTT) ≤ 1.5 x Upper Limit of Normal (ULN).\n   5. Total bilirubin ≤ 1.5 x ULN. Isolated bilirubin \\> 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C 35%.\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (AST) ≤ 1.5 x ULN. If liver metastases are present, AST and ALT ≤ 5 x ULN is permitted.\n   7. Albumin ≥ 25 g\u002FL.\n   8. One of the following:\n\n      * Creatinine ≤ 1.5 x ULN.\n      * Calculated creatinine clearance (as calculated by Cockcroft-Gault formula) ≥ 40 mL\u002Fmin.\n      * 24-hour urine creatinine clearance ≥ 40 mL\u002Fmin.\n8. Life expectancy greater than 90 days as judged by the investigator.\n9. Able to give informed consent for the study procedures defined in this protocol.\n10. Measurable disease by RECIST 1.1. For those in the Resectable and Borderline Resectable Cohorts, measurable disease must be present prior to resection surgery.\n\nExclusion Criteria:\n\n1. Presence of distant or lymph node metastases. Individuals with metastatic PDAC are not eligible.\n2. Currently receiving adjuvant (Resectable and Borderline Resectable Cohorts) or systemic (Locally Advanced Cohort) anti-cancer therapy (chemotherapy or any other anti-cancer agent) with one exception: pre-operative therapy is permitted.\n3. Not fit for chemotherapy as judged by the investigator.\n4. Presence of brain metastases.\n5. Positive pregnancy test.\n6. Unable to comply with the study assessments and procedures defined in this protocol.\n7. Individuals who are otherwise judged by the investigator to be unfit to proceed with this protocol.",{"count":185,"type":20},200,[187],"NA","The goal of this study is to learn if the genetic information and proteins from tumours can help treat pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are:\n\n* Is it feasible to obtain genetic test results within a timeframe that can help inform treatment decisions for individuals with PDAC?\n* Can the genetic test results provide information about how a tumour will respond to or resist treatment?\n\nParticipants will:\n\n* Receive standard chemotherapy to treat their cancer.\n* Provide samples of their blood, tissue, and fluid for genetic testing.\n* Visit the clinic every 4 weeks for check-ups and tests.\n* Complete questionnaires every 12 weeks.",[190,26,27,28],"Pancreatic Ductal Adenocarcinoma","2026-01-15",{"date":193,"type":33},"2026-01-16",{"date":195,"type":33},"2025-11-28",{"date":197,"type":20},"2031-12",{"name":199,"class":40},"British Columbia Cancer Agency",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":207,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":21,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":41},"100613671","phase-2-pulsar-in-systemic-therapy-for-pancreatic-cancer-100613671","NCT07269626","PULSAR in Systemic Therapy for Pancreatic Cancer","A Prospective Phase II Study of Systemic Therapy With Combined Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy (PULSAR) in Pancreatic Cancer","Inclusion Criteria:\n\n* Age ≥ 19 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Histologically confirmed pancreatic ductal adenocarcinoma.\n* Disease extent classified as borderline resectable, locally advanced, or oligometastatic disease (defined as ≤ 3 metastatic lesions) at the time of staging evaluation.\n* Completion of at least 2-4 cycles of first-line systemic therapy (FOLFIRINOX, gemcitabine\u002Fnab-paclitaxel, or NALIRIFOX) without evidence of distant progression.\n* Presence of a lesion suitable for radiotherapy, as determined by the investigator, and measurable disease per RECIST 1.1 criteria.\n* Ability to understand the study requirements and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Presence of brain metastases or leptomeningeal disease.\n* History of prior radiotherapy to the intended treatment area.\n* Significant comorbid conditions that may interfere with study participation or the ability to safely receive study treatment, as determined by the investigator (e.g., uncontrolled infection, congestive heart failure, clinically significant arrhythmia, or severe psychiatric illness).\n* Patients deemed unlikely to comply with study procedures or follow-up requirements.\n* Any condition that, in the opinion of the principal investigator or treating physician, makes the patient inappropriate for participation in this trial.","19 Years",{"count":209,"type":20},47,[54],"Pancreatic cancer remains one of the malignancies with the lowest survival rates, largely due to late-stage diagnosis and the difficulty of achieving curative resection. A substantial proportion of patients present with locally advanced, unresectable disease at the time of diagnosis, making intensive systemic therapy the current standard of care. For selected patients, radiation therapy (RT) is integrated to improve local control. Local progression in the pancreas can lead to severe complications, including intractable pain, gastric outlet obstruction, and biliary obstruction, which ultimately contribute to morbidity, deteriorating quality of life, and reduced overall survival. Therefore, effective local therapy remains a critical component of comprehensive management.\n\nHowever, delivering high-dose radiation to pancreatic tumors is particularly challenging because the pancreas is anatomically surrounded by radiation-sensitive organs such as the stomach, duodenum, liver, kidneys, and small bowel. Conventional RT and stereotactic body RT (SBRT) have both been limited by gastrointestinal toxicity, making substantial dose escalation difficult and resulting in modest local control outcomes.\n\nPrevious studies combining systemic therapy with radiotherapy have shown signals of improved local progression-free survival (LPFS) and progression-free survival (PFS). Still, results have been inconsistent across trials, highlighting the need for rigorous clinical evaluation of the true therapeutic benefit of integrating radiotherapy with systemic treatment in this disease population.\n\nConventional RT often requires several weeks of treatment, during which interruption or modification of systemic therapy may increase the risk of distant progression. SBRT shortens the treatment duration but exposes patients to large per-fraction radiation doses, increasing the risk of gastrointestinal injury and limiting eligibility to highly selected cases.\n\nAgainst this backdrop, the recently proposed PULSAR (Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy) strategy offers an innovative approach to overcome the limitations of traditional radiation therapy. PULSAR delivers 3-4 ultra-fractionated, stereotactic \"pulses\" of radiation at intervals of approximately 3-4 weeks. Each pulse is delivered with adaptive planning based on interval changes in tumor anatomy and nearby organs at risk. This wide spacing minimizes interruptions to systemic therapy and provides time for tumor shrinkage and normal tissue recovery before subsequent pulses. These features may reduce toxicity while enabling more effective dose delivery to the tumor. Such advantages are particularly relevant for pancreatic tumors located adjacent to sensitive gastrointestinal structures, potentially improving upon the limitations of SBRT.\n\nThe proton beam therapy offers additional precision through the physical characteristics of proton beams, particularly the Bragg peak, which allows for high-dose deposition within the tumor while sparing surrounding normal tissues. The combination of proton therapy with the PULSAR framework may provide a highly targeted, organ-preserving local treatment strategy for a disease known for its complex anatomy and therapeutic difficulty.\n\nWithin this context, a clinical strategy that integrates intensive first-line systemic therapy followed by PULSAR-based adaptive proton radiotherapy holds promising potential. Systemic therapy may reduce tumor burden, after which personalized, pulse-based proton irradiation can be tailored according to treatment response, delivering biologically effective doses to maximize local control while maintaining systemic treatment intensity. This approach may enhance survival outcomes by addressing both local disease control and risk of distant metastasis.\n\nIn summary, given the critical need to improve survival in locally advanced pancreatic cancer and the inherent limitations of existing radiation approaches, combining PULSAR-guided adaptive proton therapy with contemporary systemic therapy represents a compelling new treatment paradigm. This study aims to systematically evaluate the clinical feasibility, safety, and therapeutic effectiveness of this integrated approach in patients with locally advanced pancreatic cancer.",[28,27,213],"Oligometastatic Pancreatic Ductal Adenocarcinoma",[215,216,217],"Pancreatic cancer","proton beam radiotherapy","PULSAR","2025-11-25",{"date":220,"type":33},"2025-12-08",{"date":222,"type":33},"2025-11-14",{"date":224,"type":20},"2028-12-31",{"name":226,"class":40},"Samsung Medical Center",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":236,"phases":4,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":41},"100561822","determining-the-link-between-dietary-patterns-fecal-microbiome-and-response-to-neoadjuvant-chemotherapy-100561822","NCT06595160","Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy","Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy in Pancreatic Ductal Adenocarcinoma Patients","Inclusion Criteria:\n\n* \\* Age ≥ 18 years with signed informed consent form\n\n  * Patients must have a histological diagnosis of PDAC\n  * Resectable or borderline resectable PDAC on imaging\n\nExclusion Criteria:\n\n* \\* Patients with locally advanced and metastatic stage IV PDAC\n\n  * Patients who have already received or completed neoadjuvant chemotherapy for PDAC\n  * Patients with active malignancy receiving systemic therapy",{"count":235,"type":20},87,"OBSERVATIONAL","This study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.",[27,26,120],"2025-07-30",{"date":241,"type":33},"2025-08-01",{"date":243,"type":33},"2024-08-05",{"date":245,"type":20},"2027-08-07",{"name":130,"class":40}]