[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654423":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":24,"armGroups":30,"interventions":41,"overallOfficials":24,"centralContacts":24,"locations":49,"responsibleParty":70,"collaborators":24,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":24,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":24,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":52,"whyStopped":24,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"Overall Survival (OS)","Time from first antitumor treatment to death from any cause","Up to 48 months",{"measure":14,"description":15,"timeFrame":12},"Progression-Free Survival (PFS)","Time from randomization to disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.",[17,21],{"measure":18,"description":19,"timeFrame":20},"Disease Control Rate (DCR)","Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.","Every 2 months up to 18 months",{"measure":22,"description":23,"timeFrame":20},"Objective Response Rate (ORR)","Proportion of participants achieving CR or PR per RECIST 1.1.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":6,"observationalModel":24,"timePerspective":24,"maskingInfo":28},"RANDOMIZED","PARALLEL",{"masking":29,"maskingDescription":24,"whoMasked":24},"NONE",[31,36],{"label":32,"type":33,"description":24,"interventionNames":34},"IRE + chemotherapy continuation","EXPERIMENTAL",[35],"Other: IRE",{"label":37,"type":38,"description":24,"interventionNames":39},"chemotherapy continuation alone","PLACEBO_COMPARATOR",[40],"Other: PLACEBO",[42,45],{"type":6,"name":43,"description":43,"armGroupLabels":44,"otherNames":24},"IRE",[32],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":24},"PLACEBO","continue the original treatment regimen alone",[37],[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Tianjin Cancer Hospital Airport Hospital","RECRUITING","Tianjin","Tianjin Municipality","300308","China","CN",{"type":59,"coordinates":60},"Point",[61,62],117.17667,39.14222,{"lat":62,"lon":61},[65],{"name":66,"role":67,"phone":68,"phoneExt":24,"email":69},"Li Huikai, MD","CONTACT","18622228639","tjchlhk@126.com",{"type":71,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100654423","ire-after-chemotherapy-for-locally-advanced-pancreatic-cancer-100654423",false,"NCT07799935","IRE After Chemotherapy for Locally Advanced Pancreatic Cancer","A Prospective, Randomized Controlled Phase II Clinical Study on Sequential or Non-Sequential Irreversible Electroporation Ablation After Chemotherapy Induction in Patients With Locally Advanced Unresectable Pancreatic Cancer","Inclusion Criteria:\n\n* Age 18-75 years, any sex.\n\nPrimary tumor biopsy confirms pancreatic adenocarcinoma.\n\nNon-progressive disease (PR or SD) after three cycles of chemotherapy induction.\n\nLocally advanced pancreatic cancer with \\>180-degree involvement of major vessels (celiac axis, superior mesenteric artery, superior mesenteric vein, or portal vein), confirmed unresectable by MDT review.\n\nNo prior palliative chemotherapy (except neoadjuvant\u002Fadjuvant chemotherapy discontinued \\>6 months); no other systemic antitumor therapy.\n\nAt least one measurable lesion per RECIST 1.1.\n\nAdequate organ and marrow function: hemoglobin ≥9.0 g\u002FdL; neutrophils ≥1.5×10⁹\u002FL; platelets ≥100×10⁹\u002FL; TBIL ≤3×ULN; AST and ALT ≤5.0×ULN; serum creatinine ≤1.5×ULN or CrCl \\>60 mL\u002Fmin.\n\nECOG Performance Status 0-1.\n\nExpected survival ≥3 months.\n\nPatients of childbearing potential and partners agree to use contraception.\n\nVoluntary written informed consent.\n\nExclusion Criteria:\n\n* Refusal to receive systemic chemotherapy or possible surgery.\n\nMetastasis to other sites (liver, peritoneum, lung, bone, brain).\n\nHistory of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ).\n\nSevere uncontrolled comorbidities (NYHA III\u002FIV heart failure, unstable angina, uncontrolled arrhythmia\u002Fhypertension, active infection, uncontrolled diabetes, uncontrolled effusions\u002Fascites requiring drainage, severe portal hypertension\u002Fcavernoma, gastric outlet obstruction, respiratory insufficiency requiring oxygen).\n\nMajor surgery within 30 days before screening.\n\nEGFR monoclonal antibody within 30 days before screening.\n\nAllergy to any drug or component used in this protocol.\n\nKnown HIV infection or chronic hepatitis B\u002FC.\n\nUnresolved toxicity ≥CTCAE grade 2 from prior treatment (except anemia, alopecia, skin pigmentation, chemotherapy-induced neurotoxicity).\n\nAny other reason judged by the investigator to make participation inappropriate.","ALL","18 Years","75 Years",{"count":83,"type":84},60,"ESTIMATED","INTERVENTIONAL",[87],"NA","This is a prospective, randomized, controlled, exploratory Phase II clinical study. Approximately 60 eligible patients with locally advanced pancreatic cancer who have received three cycles of chemotherapy induction and have non-progressive disease will be enrolled. All patients must be considered unresectable by MDT review and must provide written informed consent. Participants will be randomized 2:1. Forty patients will undergo open IRE followed by continuation of the original chemotherapy regimen; twenty patients will continue the original treatment regimen alone. OS, PFS, tumor response, QoL, safety, and postoperative outcomes will be observed.",[43],[43],"2026-08-28",{"date":93,"type":94},"2026-09-02","ACTUAL",{"date":96,"type":94},"2026-05-20",{"date":98,"type":84},"2027-12-31",{"name":5,"class":6},1]