[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580985":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":48,"collaborators":30,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":30,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":30,"studyType":64,"phases":65,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":34,"whyStopped":30,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Shandong Cancer Hospital and Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Stereotactic Body Radiotherapy Combined with Chemotherapy and Enhancement of Novel Drug Ivonescimab","EXPERIMENTAL","1. Phase Ib (Dose Escalation):\n\n   In this phase, patients will receive Ivonescimab in escalating doses, with the aim of determining the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and the recommended Phase II dose (RP2D). The dose-escalation process will follow a 3+3 design over a 4-week period to establish the RP2D of Ivonescimab.\n2. Phase II (Efficacy Evaluation):\n\nAfter establishing the RP2D, patients will receive Ivonescimab combined with SBRT and modified FOLFIRINOX chemotherapy.",[13],"Drug: Ivonescimab",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","Ivonescimab",[9],[20,21],"Adapted Guided Stereotactic Body Radiotherapy","Chemotherapy",[23],{"name":24,"affiliation":5,"role":25},"Jinbo Yue, Doctor","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","0531-67626442",null,"jbyue@sdfmu.edu.cn",[33],{"facility":5,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Jinan","Shandong","0531","China","CN",{"type":41,"coordinates":42},"Point",[43,44],116.99722,36.66833,{"lat":44,"lon":43},[47],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},{"type":25,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Jinbo Yue","Director of Department Radiation Oncology","100580985","phase-1-adapted-guided-stereotactic-body-radiotherapy-combined-with-chemotherapy-and-enhancement-of-novel-drug-ivonescimab-for-pancreatic-cancer-ascend-100580985",false,"NCT06844422","Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND)","Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND) -A Single-Arm Phase Ib\u002FII Trial","Inclusion Criteria:\n\n1. Pathologically or cytologically confirmed unresectable LAPC, as defined by the 8th edition of the American Joint Committee on Cancer (AJCC);\n2. Age between 18 and 80 years;\n3. At least one measurable pancreatic cancer lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n5. Life expectancy of at least 3 months;\n6. Adequate hematological, renal, and hepatic function, as defined by the following criteria (within 14 days prior to enrollment): (1) Hemoglobin (Hb) ≥ 90 g\u002FL; Absolute Neutrophil Count (ANC) ≥ 1.0 × 10\\^9\u002FL; Platelet count (PLT) ≥ 75 × 10\\^9\u002FL; (2) No significant organ dysfunction, with the following criteria: Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) or direct bilirubin ≤ ULN if total bilirubin \\> 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Alkaline phosphatase (ALP) ≤ 2.5 × ULN, or ≤ 2.5 × ULN for the liver fraction if ALP \\> 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance (using the MDRD formula) ≥ 40 mL\u002Fmin if serum creatinine is \\> 1.5 × ULN; Urine protein \\\u003C 2+, or if ≥ 2+ on dipstick, 24-hour urine protein must be \\\u003C 2 g or the urine protein-to-creatinine ratio (UPC) must be \\\u003C 2; International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;\n7. Ability to provide tissue and blood samples for translational research;\n8. Ability to comprehend study details and provide written informed consent.\n\nExclusion Criteria:\n\n1. History of any malignant tumors within the past 5 years, except for cured localized tumors;\n2. Uncontrolled infections (e.g., active tuberculosis or hepatitis), uncontrolled systemic diseases, poorly controlled hypertension or diabetes, or severe comorbidities within the past six months, including myocardial infarction, cerebral embolism, or significant arrhythmias;\n3. Previous treatment with drugs targeting other stimulatory or co-inhibitory T-cell receptors;\n4. Prior radiotherapy within 2 weeks before enrollment;\n5. Known allergy to Ivonescimab or its excipients;\n6. Pregnancy or lactation;\n7. Current or planned use of strong CYP3A4\u002F5 or CYP1A2 inducers or strong CYP3A4\u002F5 inhibitors;\n8. Requirement for oral vitamin K antagonists for anticoagulation. Low-dose warfarin (≤ 2 mg\u002Fday) and other low-dose anticoagulants for maintaining central venous access or preventing deep vein thrombosis are permitted. Low-molecular-weight heparin is also permitted;\n9. Conditions affecting oral medication administration, such as a history of gastrointestinal perforation or fistula within the past 6 months, history of intestinal obstruction, extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea.","ALL","18 Years","75 Years",{"count":62,"type":63},37,"ESTIMATED","INTERVENTIONAL",[66,67],"PHASE1","PHASE2","This study aims to evaluate the safety and efficacy of Ivonescimab, a bispecific antibody targeting PD-1 and VEGF, in combination with stereotactic body radiotherapy (SBRT) and chemotherapy for treating locally advanced pancreatic cancer (LAPC). The Phase Ib portion is a dose-escalation study to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and the recommended Phase II dose (RP2D) of Ivonescimab. The Phase II portion will assess the median progression-free survival (mPFS) of patients receiving Ivonescimab with SBRT (25-50Gy\u002F5F) and modified FOLFIRINOX chemotherapy. The study aims to provide critical insights into treatment options for LAPC and inform future therapeutic strategies.",[70],"Pancreatic Cancer",[20,21,17,70],"2026-04-27",{"date":74,"type":75},"2026-04-28","ACTUAL",{"date":77,"type":75},"2025-02-08",{"date":79,"type":63},"2028-02-18",{"name":5,"class":6},1]