[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-pancreatic-ductal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-pancreatic-ductal-adenocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,42,54,78,110,136,157,181,208,229,253],{"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":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":44,"targetDuration":4,"studyType":21,"phases":45,"briefSummary":24,"conditions":46,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":53,"locationsCount":41},"100643239",{"count":19,"type":20},[23],[26,27,28],"2026-06-08",{"date":49,"type":33},"2026-06-12",{"date":51,"type":20},"2026-07-01",{"date":37,"type":20},{"name":39,"class":40},{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":41},"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":62,"type":20},56,[23,64],"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.",[67,28],"Borderline Resectable Pancreatic Adenocarcinoma","RECRUITING","2026-05-19",{"date":71,"type":33},"2026-05-22",{"date":73,"type":33},"2023-03-07",{"date":75,"type":20},"2027-03-02",{"name":77,"class":40},"Jonsson Comprehensive Cancer Center",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"100605016","phase-1-a-phase-1-study-to-evaluate-safety-and-efficacy-of-xer-001-amifostine-for-nasoduodenal-delivery-in-combination-with-sterotactic-body-radiotherapy-for-treatment-in-patients-with-locally-advanced-pancreatic-cancer-100605016","NCT07157033","A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment in Patients With Locally Advanced Pancreatic Cancer.","A Phase 1\u002F2a, Open Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of XER-001 (Amifostibe for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment of Locally-Advanced Pancreatic Adenocarcinoma","XER-001","Inclusion Criteria:\n\n1. Cytologic or biopsy confirmed adenocarcinoma of the pancreas\n2. Disease deemed amenable to definitive treatment with SBRT by being:\n\n   1. Locally-advanced and\u002For technically unresectable, as determined by a specialist pancreaticobiliary surgeon and as part of a multidisciplinary team review including of multiphase cross-sectional imaging, demonstrating: i. Greater than 180-degree tumor involvement of the superior mesenteric artery (SMA) ii. Greater than 180-degree tumor involvement of the celiac axis including major branches of the celiac axis that would render the tumor unresectable (e.g. common hepatic artery) iii. Tumor involvement of the first branch of the SMA that is not surgically reconstructible iv. Long segment involvement of the superior mesenteric vein\u002Fportal vein\u002Fhepatic artery that is not amenable to surgical reconstructible.\n   2. Potentially resectable anatomically but deemed not a surgical candidate after multidisciplinary review (such as unresectable due to comorbid conditions that render.\n\n      the risks of surgery prohibitive)\n   3. Potentially resectable but the patient elects to refuse surgery and prefers to pursue SBRT, and disease is deemed eligible for SBRT\n3. Primary tumor involvement abutment of the bowel is allowed, however bowel infiltration or invasion (identified endoscopically or by contrast enhanced imaging) is not allowed.\n4. No distant metastatic disease either prior to or following induction systemic therapy\n5. Completion of medically indicated first line systemic therapy, which may include but is not limited to regimens such as FOLFIRNOX, gemcitabine\u002Fabraxane, and similar regimens\n6. Patients must be able to understand and comply with any treatment related procedures for SBRT. including breath-hold techniques or tolerance of compression belt, or other motion management strategies for SBRT delivery.\n7. Age 18 years or older\n8. Eastern Cooperative Group (ECOG) performance status 0, 1, or 2\n9. Adequate hematologic function as indicated by:\n\n   1. Absolute neutrophil counts \\>\u002F= 1500\u002Fmm3\n   2. Hemaglobin \\>\u002F= 8.0 g\u002FdL\n   3. Plor current use of hepato atelet count \\>\u002F= 75,000\u002Fmm3\n10. No known liver disease or hepatic impairment, as well as no recent or current use of hepatotoxic drugs or substances that could compromise liver function unless a washout period has been completed. Adequate liver function as indicated by:\n\n    1. Total bilirubin \\\u003C\u002F= 1.5x upper limits of normal (per institutional laboratory reference standard)\n    2. Aspartate aminotransferase (AST) and alanine aminotranferase (ALT) \\\u003C\u002F= 2.5 upper limits of normal (per institutional reference standard)\n11. Baseline serum calcium level \\>\u002F= 8.4 mg\u002FdL\n12. No clinically significant history or presence of safety 12-lead ECG findings as judged by the investigator at screening and check-in(s), including each criterion as listed below:\n\n    1. Normal sinus rhythm (heart rate between 40 and 100 bpm)\n    2. QTcF interval \\\u003C\u002F= 470 msec\n    3. QRS interval \\\u003C\u002F= 110 msec\n    4. and PRS interval \\\u003C\u002F= 220 msec Repeat measurements may be performed at the discretion of the investigator or designee\n13. An understanding, ability, and willingness to fully comply with the protocol-defined schedule of assessments, procedures, and restrictions\n14. Must provide written informed consent prior to the initiation of any protocol specific procedures\n15. The effects of XER-001 on the developing human fetus are unknown. For this reason women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least six months following the last (fifth) day of radiotherapy on this study. Exceptions to this inclusion criterion are available to women who meet any of the following criteria:\n\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months or validated by follicle stimulating hormone \\[FSH\\] levels.\n    * History of hysterectomy or bilateral salpingo-oophorectomy\n    * Ovarian failure (FSH and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)\n    * History of bilateral tubal ligation or another surgical sterilization procedure\n16. Approved methods of birth control are as follows: hormonal contraception (I.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy, subject\u002Fpartner post vasectomy, implantable or injectable contraceptives, and condoms with spermacide. Not engaging in sexual activity through six months following the last (fifth) day of radiotherapy on this study is an acceptable practice; however periodic abstinence, the rhytm method, and the withdrawal method are not acceptable methods of birth control. 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\nFor male participants on this trial, contraception is required as above dusing the study and for at least three months following the last (fifth) day of radiotherapy on this study if the have partners who can become pregnant (woman of child-bearing potential). Similarly, male participants on this trial should not donate sperm during the study and for at lease three months following the last (fifth) day of radiotherapy on this study.\n\nExclusion Criteria:\n\n1. Prior radiotherapy to the upper abdomen with overlap of. the anticipated SBRT field\n2. Prior radiopharmaceutical therapy\n3. Prior surgical resection of the pancreatic tumor\n4. Uncontrolled or active gastric or duodenal ulcer disease within 30 days of enrollment\n5. Visable invasion of tumor into the bowel\u002Fstomach.duodenal lumen on endoscopic evaluation\n6. Residual or ongoing grade 3+ non-hemotological toxicity from chemotherapy other than alopecia\n7. Concurrent participation in another interventional clinical trial or use of another investigational agent within 30 days of study consent. Note that participation in non-interventional clinical trials (e.g. quality of life \\[QOL\\], imaging, etc) is not exclusionary\n8. Uncontrolled intercurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia\n9. Patients with history of myocardial infarction or unstable angina within 6 months prior to study enrollment\n10. Patients with history of symptomatic or (CTCAE-defined) grade 3+ hypocalcemia\n11. Patients with history of hypoparathyroidism\n12. Patients with history of hypertension where medical providers deem that interruption of antihypertensive regimen for one week is deemed unsafe.\n13. Patients with systolic blood pressure (BP) \\\u003C 100 or diastolic BP \\\u003C 65 at screening or baseline\n14. History or presence of a disease, such as hepatic impairment or renal insufficiency, that could affect the absorption, distribution, metabolism, or elimination of the investigational product, tolerance to radiotherapy, or could affect clinical or laboratory assessments.\n\n    Patients with an estimated glomerular filtration rate of less than 30 mL per minute are excluded from the trial. Patients with total bilirubin greater than 2.5 mg\u002FdL are excluded from the trial unless patient has history of Gilbert's syndrome. In case of suspected or confirmed Gilbert's syndrome, bilirubin will be fractionated, and patients with direct bilirubin greater than 1.5 mg\u002FdL will be excluded from the trial.\n15. History of cardiac-related condition, which may include, but is not limited to, torsades de pointes, ventricular fibrillation, or ventricular tachycardia\n16. Presence or family history (parents and siblings) of congenital lqt syndrome or any premature history of myocardial infarction considered clinically significant by the investigator or designee\n17. History or presence of palpitations, unexplained syncope, shortness of breath or any other symptoms that may relate to cardiac arrhythmias\n18. Any ECG evidence of physiological variants predisposing to electrical instability (eg. frequent pre-ventricular systolic beats)\n19. Medical disorder that may require treatment during the study or make the subject unlikely to complete the study.\n20. Inability to fast for 3 hours prior to study drug administration\n21. Known history of active hepatitis B\u002FC or active human immunodeficiency virus (HIV) not on highly-active anti-retroviral therapy for a minimum of 30 days\n22. Donation or loss of more than 500 ml of whole blood within 30 days prior to screening\n23. Difficulty with venous access or unstable or unwilling to undergo catheter insertion\n24. Female subjects who are currently pregnant (have a positive pregnancy test), are lactating, or planning to breastfeed. Pregnant or breastfeeding women are excluded from this study because there is an unknown risk for adverse events in nursing infants secondary to treatment of the mother with amifostine, breastfeeding should be discontinued if the mother is treated with amifostine\n25. An employee of the sponsor or research site personnel directly affiliated with this study or their immediate family member defined as a spouse, parent, child, or sibling, whether biological or legally adopted\n26. A subject who, in the opinion of the investigator or designee, is considered unsuitable or unlikely to comply with the study protocol for any reason",{"count":87,"type":20},36,[23,64],"The purpose of this study is to assess the safety, tolerability and efficacy of XER-001 and identify a best dose for future studies.",[91,92,28],"Locally Advanced Pancreatic Adenocarcinoma","Locally Advanced Pancreas Cancer",[94,95,96,97,98],"locally advanced pancreatic cancer","pancreatic cancer","locally advanced pancreatic adenocarcinoma","SBRT","amifostine","2026-04-29",{"date":101,"type":33},"2026-05-01",{"date":103,"type":33},"2026-01-01",{"date":105,"type":20},"2034-07-31",{"name":107,"class":108},"Xerient Pharma","INDUSTRY",4,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":119,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":41},"100599857","early-phase-1-omo-103-for-the-treatment-of-locally-advanced-or-metastatic-pancreatic-ductal-adenocarcinoma-100599857","NCT07089940","OMO-103 for the Treatment of Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma","An Early Phase 1 Trial to Assess Pharmacodynamic Effects of OMO-103 in Patients With Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Must provide written informed consent before any study-specific procedures or interventions are performed\n* Must be ≥ 18 years old at the time of informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Clinically-confirmed diagnosis of locally-advanced or metastatic adenocarcinoma of the pancreas\n\n  * Participants may be treatment naïve or have received prior therapy for the treatment of their PDAC. A minimum washout period of 14-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* Patient agrees to undergo a minimum of 2 biopsies (pre- and post-treatment). Note: at principal investigator (PI) discretion, archival sample may be obtained in lieu of pre-treatment biopsy\n* Hemoglobin ≥ 7.5 g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL (\\> 1500 per mm\\^3)\n* Platelet count ≥ 75 x 10\\^9\u002FL (\\> 100,000 per mm\\^3)\n* Calculated creatinine clearance \\> 50 mL\u002Fmin\u002F1.73m\\^2 (per Cockcroft-Gault equation)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT): ≤ 3 x upper limit of normal (ULN), or ≤ 5 x ULN in presence of liver metastases\n* Participants of childbearing potential (POCBP) must agree to abstain from sexual intercourse or use effective methods of contraception starting with the first dose of study therapy through 6 months from the last dose of study intervention\n* POCBP may participate provided they have a negative serum pregnancy test at screening and a negative serum OR urine pregnancy test within 7 days of starting treatment\n* Sperm-producing participants must agree to abstain from sexual intercourse or use effective contraception starting with the first dose through 6 months after last dose of study intervention\n\nExclusion Criteria:\n\n* Concomitant use of other anti-cancer therapy otherwise not permitted in this protocol, including: chemotherapy, immunotherapy, hormonal therapy (hormone replacement therapy is acceptable), radiotherapy (except for palliative), biological therapy, or other novel agent\n* Prior anti-cancer therapy within 2 weeks prior to study enrollment\n* Prior treatment with a MYC inhibitor\n* Known severe hypersensitivity to OMO-103 or to any excipient of these medicinal products, or history of allergic reactions attributed to compounds of similar chemical or biologic composition\n* Major surgery within 6 weeks prior to enrollment\n* Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and myocardial infarction within 3 months of initiating study intervention\n* History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent\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 6 months after the last dose of trial treatment\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements",{"count":118,"type":20},12,[120],"EARLY_PHASE1","This early phase I trial studies the biological activity of OMO-103 in patients with pancreatic ductal adenocarcinoma 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). OMO-103 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial may help researchers determine how exposure to OMO-103 changes pancreatic tumor cells.",[28,123,124,125,126],"Metastatic Pancreatic Ductal Adenocarcinoma","Stage II Pancreatic Cancer AJCC v8","Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","2026-03-19",{"date":129,"type":33},"2026-03-23",{"date":131,"type":33},"2026-01-27",{"date":133,"type":20},"2027-12-31",{"name":135,"class":40},"OHSU Knight Cancer Institute",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"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":144,"type":20},90,[120],"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.",[28,123,124,125,126,148,27,26],"Unresectable Pancreatic Ductal Adenocarcinoma","2026-02-26",{"date":151,"type":33},"2026-02-27",{"date":153,"type":33},"2019-08-01",{"date":155,"type":20},"2028-02-01",{"name":135,"class":40},{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"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":166,"type":20},200,[168],"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.",[171,26,27,28],"Pancreatic Ductal Adenocarcinoma","2026-01-15",{"date":174,"type":33},"2026-01-16",{"date":176,"type":33},"2025-11-28",{"date":178,"type":20},"2031-12",{"name":180,"class":40},"British Columbia Cancer Agency",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":188,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":21,"phases":191,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"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":190,"type":20},47,[64],"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.",[28,27,194],"Oligometastatic Pancreatic Ductal Adenocarcinoma",[196,197,198],"Pancreatic cancer","proton beam radiotherapy","PULSAR","2025-11-25",{"date":201,"type":33},"2025-12-08",{"date":203,"type":33},"2025-11-14",{"date":205,"type":20},"2028-12-31",{"name":207,"class":40},"Samsung Medical Center",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":217,"phases":4,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":41},"100562264","hyperpolarized-13c-mri-to-predict-response-in-pancreatic-cancer-100562264","NCT06600906","Hyperpolarized 13C MRI to Predict Response in Pancreatic Cancer","Translating Hyperpolarized 13C MRI as a Novel Tool to Predict Treatment Response in Pancreatic Cancer","Inclusion Criteria:\n\n* Participants must be 18 years or older.\n* Histological or cytological confirmation of pancreatic ductal adenocarcinoma (PDA).\n* Locally advanced or metastatic disease.\n* At least one target lesion in the abdomen measuring ≥ 1centimeter (cm), according to RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 (Karnofsky ≥ 50%)\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.\n* Poorly controlled hypertension, defined as either systolic \\> 170 or diastolic \\> 110. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.\n* Congestive Heart Failure ≥ Class III.\n* Participants who are pregnant.\n* Individuals of childbearing potential must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of HP 13C pyruvate to the study participant. A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (\\>= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n* Participants who are breastfeeding\u002Fchestfeeding. Breastfeeding\u002Fchestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to administration of HP 13C pyruvate to the study participant. Breastfeeding\u002Fchestfeeding should be discontinued before administration of HP 13C pyruvate.\n* Known hypersensitivity to HP 13C pyruvate or any of its excipients.\n* Participants with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures",{"count":216,"type":20},70,"OBSERVATIONAL","This study evaluates an investigational scan called hyperpolarized carbon-13 pyruvate magnetic resonance imaging (MRI) in assessing treatment response in patients with pancreatic ductal carcinoma (PDA) 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). MRI is a standard scan that helps doctors see tumors, organs, tissue, and bone. Standard contrast agents (e.g., gadolinium) are sometimes used to help make the scan images brighter, or easier to see. Hyperpolarized carbon-13 pyruvate is an experimental contrast agent that is different from standard MRI contrast in that it provides information on how a tumor processes nutrients. Hyperpolarized carbon-13 pyruvate MRI scans may work better than MRI with standard contrast agents in predicting how PDA tumors respond to treatment.",[171,123,28],"2025-11-07",{"date":222,"type":33},"2025-11-12",{"date":224,"type":33},"2024-10-01",{"date":226,"type":20},"2032-09-01",{"name":228,"class":40},"University of California, San Francisco",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":21,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":41},"100600760","phase-2-a-study-of-gnp-regimencombined-with-serplulimab-and-stereotactic-body-radiation-therapy-as-first-line-treatment-for-locally-advanced-pancreatic-cancer-100600760","NCT07101679","A Study of GnP RegimenCombined With Serplulimab and Stereotactic Body Radiation Therapy as First-line Treatment for Locally Advanced Pancreatic Cancer","A Phase II Clinical Study of GnP Regimen (Nab-paclitaxel + Gemcitabine) Combined With Serplulimab and Stereotactic Body Radiation Therapy (SBRT) as First-line Treatment for Locally Advanced Pancreatic Cancer","Inclusion Criteria:\n\n1. Inclusion Criteria (1)Histologically confirmed pancreatic ductal adenocarcinoma with diagnosis based on comprehensive assessment of pathology and imaging studies (CT or MRI), supplemented by fibroblast activation protein positron emission tomography-computed tomography (FAPI PET-CT) when necessary, determined as locally advanced pancreatic cancer by multidisciplinary team assessment (per 2022 CSCO guideline definition) and deemed unresectable; (2)Treatment-naïve patients with no prior anticancer therapy (including chemotherapy, radiotherapy, surgery, radiofrequency ablation, irreversible electroporation, or other investigational treatments); (3)Age 18-75 years, inclusive, regardless of sex; (4)Eastern Cooperative Oncology Group (ECOG) performance status 0-2; (5)Measurable primary tumor lesions: ≥10 mm in longest diameter on spiral CT, lymph nodes ≥15 mm in short axis diameter; for conventional CT or physical examination, maximum diameter must be ≥20 mm; (6)Adequate major organ function:\n\n   * Bone marrow function (no blood transfusion within 14 days prior to screening): White blood cell count (WBC) ≥4.0×10⁹\u002FL, absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelet count (PLT) ≥80×10⁹\u002FL, hemoglobin (Hb) ≥90 g\u002FL;\n   * Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (for subjects with hepatic metastases: ALT and AST ≤5×ULN, TBIL ≤2×ULN), Child-Pugh score ≤7;\n   * Renal function: Serum creatinine (Cr) ≤1.5×ULN, proteinuria ≤2+ or ≤2 g\u002F24h, glomerular filtration rate (GFR) ≥60 mL\u002Fmin\u002F1.73 m²;\n   * Coagulation function: Prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR) ≤1.5×ULN. Patients receiving stable anticoagulation therapy for at least 30 days prior to study drug treatment may have PT or INR \\>1.5×ULN if deemed appropriate for the study by investigator assessment, provided adequate justification is documented;\n   * Serum sodium, potassium, calcium, and magnesium levels ≤Grade 1 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0;\n   * Electrocardiogram showing corrected QT interval (QTc) ≤480 ms; (7)No history of autoimmune disease or current autoimmune disease; (8)Life expectancy ≥3 months; (9)Signed written informed consent prior to any study-related procedures, with ability to understand the protocol and comply with study requirements.\n\nExclusion Criteria:\n\n1. Known hypersensitivity or allergy to any of the study drugs;\n2. Patients with distant metastatic disease classified as Stage IV pancreatic cancer;\n3. Patients whose tumor lesions are determined by the surgical team or multidisciplinary team to be resectable or borderline resectable pancreatic cancer based on imaging studies (CT or MRI) (per 2022 CSCO guideline definition);\n4. Patients whose lesions are deemed unsuitable for stereotactic body radiation therapy (SBRT) by investigator assessment;\n5. Known or suspected central nervous system (CNS) metastases, defined as subjects with signs or symptoms suggestive of CNS metastases, unless CNS metastases have been excluded by CT or MRI;\n6. History of other malignancies within 5 years (except adequately treated basal cell carcinoma of the skin and cervical carcinoma in situ);\n7. Requirement for concurrent anticancer treatments other than the study treatment regimen during the study period, including chemotherapy, targeted therapy, hormonal therapy, immunotherapy regimens, radiotherapy, or traditional Chinese medicine with anticancer properties;\n8. Prior or current use of chemotherapy, focal adhesion kinase (FAK) inhibitors, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies (including ipilimumab or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways);\n9. Diagnosis of immunodeficiency or receiving chronic systemic corticosteroid therapy (daily dose exceeding 10 mg prednisone or equivalent) or any other form of immunosuppressive treatment within 7 days prior to first study drug administration;\n10. Receipt of live vaccines within 30 days prior to first study drug treatment (including but not limited to: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, bacillus Calmette-Guérin \\[BCG\\], and typhoid vaccines). Inactivated vaccines such as injectable seasonal influenza vaccines are permitted, but live attenuated vaccines such as intranasal influenza vaccines (e.g., FluMist) are not allowed;\n11. Uncontrolled hypertension (defined as systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg despite treatment);\n12. Significant cardiac disease, including congestive heart failure (New York Heart Association \\[NYHA\\] Class III-IV), prior myocardial infarction, or uncontrolled angina within 6 months;\n13. Cardiac arrhythmias requiring treatment, including atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or ventricular fibrillation; confirmed ECG abnormalities deemed by the investigator to require clinical intervention or treatment;\n14. History of hemorrhagic or thromboembolic events within 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or spontaneous major tumor bleeding;\n15. Need for surgical treatment within 28 days before or anticipated within 28 days after the last study drug administration;\n16. Presence of poorly controlled third-space fluid collections, such as large pleural effusions or ascites;\n17. istory of gastrointestinal perforation or suspected risk of gastrointestinal perforation;\n18. Investigator determination that concomitant medications required during the study period may affect study drug metabolism, such as strong CYP3A4 inhibitors or inducers, drugs primarily metabolized by CYP3A4, 2C8, 2C9, 2C19, or 2D6 with narrow therapeutic indices;\n19. Severe psychiatric disorders;\n20. Pregnancy, potential pregnancy, or lactation;\n21. Subjects of childbearing potential unwilling to use contraception during the study period and for 3 months after the last study drug administration;\n22. Participation in other drug or medical device clinical trials within 4 weeks prior to study entry;\n23. Any condition deemed inappropriate for study participation by investigator judgment.","75 Years",{"count":238,"type":20},23,[64],"This study is a single-arm phase II clinical trial. The study targets patients aged 18-75 years with ECOG performance status 0-2, diagnosed with locally advanced pancreatic ductal adenocarcinoma based on comprehensive assessment of pathology and imaging studies (CT or MRI). Participating patients will receive the GnP regimen every 21 days (nab-paclitaxel 125mg\u002Fm² ivgtt on days 1 and 8 + gemcitabine 1000mg\u002Fm² ivgtt on days 1 and 8, repeated every 21 days) combined with serplulimab (200mg ivgtt Q3W). In the second cycle, patients will receive SBRT targeting the primary tumor and\u002For retroperitoneal lymph nodes: 6.6Gy×5 fractions, 7Gy×5 fractions, or 8Gy×5 fractions, administered every other day with radiotherapy completed in 5 sessions (specific selection determined by investigators based on lesion size and organs at risk \\[OAR\\] assessment). Comprehensive evaluation including tumor markers and CT scans will be performed every 2 cycles with multidisciplinary team (MDT) review, and patients who meet surgical criteria will undergo radical resection surgery.",[28],[97,243],"serplulimab","2025-08-02",{"date":246,"type":33},"2025-08-07",{"date":248,"type":33},"2025-04-16",{"date":250,"type":20},"2029-04-15",{"name":252,"class":40},"West China Hospital",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":236,"enrollmentInfo":260,"targetDuration":4,"studyType":21,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":41},"100552357","phase-2-ag-combined-with-cadonilimab-sequential-short-course-radiotherapy-in-the-treatment-of-locally-apdac-100552357","NCT06472037","AG Combined With Cadonilimab Sequential Short-course Radiotherapy in the Treatment of Locally aPDAC","A Prospective, Single-arm, Phase II Study Assessing the Efficacy of Gemcitabine, Nab-paclitaxel, and Cadonilimab With Sequential Short-course Radiotherapy in Locally Advanced Pancreatic Ductal Adenocarcinoma Patients.","Inclusion Criteria:\n\nPatients eligible for this study must meet all of the following criteria:\n\n1. Obtain written informed consent before implementing any trial-related procedures;\n2. Age ≥ 18 years and ≤ 75 years, gender not specified;\n3. Pancreatic cancer confirmed by histopathology examination;\n4. Locally advanced pancreatic ductal adenocarcinoma and no prior anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) received;\n5. At least one measurable lesion on imaging according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n6. ECOG score 0-1;\n7. Expected survival time \\>3 months;\n8. Adequate organ function, subjects must meet the following laboratory criteria:\n\n1)Absolute neutrophil count (ANC) ≥1.5x10\\^9\u002FL without the use of granulocyte colony-stimulating factor in the past 14 days.\n\n2)Platelet count ≥100x10\\^9\u002FL without blood transfusion in the past 14 days. 3)Hemoglobin \\> 9g\u002FdL without blood transfusion or use of erythropoietin in the past 14 days; 4)Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); 5)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN; 6)Serum creatinine ≤ 1.5 times ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60ml\u002Fmin; 7)Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8)Normal thyroid function is defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be included in the study.\n\n9.For female subjects of childbearing potential, a urine or serum pregnancy test should be performed within 3 days before receiving the first dose of the study drug (Day 1 of Cycle 1) and the result should be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing potential female subjects are defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy.\n\n10.All subjects, male or female, were required to use contraception with an annual failure rate of less than 1% during the entire treatment period up to 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapeutic drug) if there was a risk of pregnancy.\n\nExclusion Criteria:\n\n1. Malignant diseases other than pancreatic cancer diagnosed within 5 years before the first administration (excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ after radical resection);\n2. Is currently participating in an interventional clinical study or has received other study medication or used the study device within 4 weeks prior to the first dose;\n3. Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs directed against another stimulatory or synergistic T cell receptor suppressor (e.g., CTLA-4, OX-40, CD137);\n4. Systemic treatment of Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control ascites) within 2 weeks before the first administration;\n5. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic therapy;\n6. Is receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal, inhaled, or other routes) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; Note: The use of physiological doses of glucocorticoids (≤10mg\u002Fday of prednisone or equivalent) is allowed;\n7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n8. Known allergy to the investigational drug carfilzomib, gemcitabine, or any excipient of albumin-bound paclitaxel;\n9. Have not fully recovered from any toxicities and\u002For complications due to any prior interventions before starting treatment (i.e., ≤ Grade 1 or back to baseline, excluding fatigue or alopecia);\n10. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV-1\u002F2 antibody positive);\n11. Uncontrolled active hepatitis B (defined as HBsAg positive with detectable HBV-DNA copies above the upper limit of normal for the testing laboratory at the study center);\n\nNote: Subjects with the following criteria can also be included:\n\n1. HBV viral load \\\u003C1000 copies\u002Fml (200 IU\u002Fml) before the first dose, subjects should receive anti-HBV treatment throughout the study drug treatment period to prevent viral reactivation\n2. Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) do not need to receive prophylactic anti-HBV treatment, but need close monitoring for viral reactivation 12.Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the detection limit); 13.Received live vaccines within 30 days before the first dose (Cycle 1, Day 1); Note: Administration of inactivated influenza vaccine for seasonal flu is allowed within 30 days before the first dose, but intranasal live attenuated influenza vaccine is not allowed.\n\n14.Pregnant or lactating women; 15.Presence of any severe or uncontrolled systemic diseases, such as:\n\n1. Resting electrocardiogram showing significant and symptomatic abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation;\n2. Unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) class ≥2;\n3. Any arterial thrombosis, embolism, or ischemia events such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to initiation of therapy;\n4. Suboptimal blood pressure control (systolic blood pressure \\>140mmHg, diastolic blood pressure \\>90mmHg);\n5. History of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to initial dosing, or current clinical active interstitial lung disease;\n6. Active pulmonary tuberculosis;\n7. Active or uncontrolled infections requiring systemic therapy.\n8. Clinical active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction;\n9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n10. Poorly controlled diabetes (fasting blood glucose (FBG) \\>10mmol\u002FL);\n11. Urinalysis shows urine protein ≥++, and confirmed 24-hour urine protein quantification \\>1.0g;\n12. Presence of mental disorders and inability to cooperate with treatment; 16 There may be potential risks that could interfere with the trial results, hinder the full participation of subjects in the study, such as medical history or evidence of diseases, abnormal treatment or laboratory test values, or other conditions deemed unsuitable for inclusion by the researchers. Researchers may also identify other potential risks that make participation in this study unsuitable.",{"count":261,"type":20},30,[64],"A prospective, single-arm, exploratory phase II clinical study evaluating the efficacy of Gemcitabine and Nab-palitaxe combined with Cadonilimab sequential short-course radiotherapy in the treatment of patients with locally advanced pancreatic ductal adenocarcinoma.",[28],"2024-12-01",{"date":267,"type":33},"2024-12-04",{"date":269,"type":33},"2024-07-01",{"date":271,"type":20},"2025-07-01",{"name":273,"class":40},"Tianjin Medical University Cancer Institute and Hospital"]