[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653996":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":27,"interventions":39,"overallOfficials":20,"centralContacts":46,"locations":52,"responsibleParty":70,"collaborators":20,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":20,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":20,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":20,"overallStatus":55,"whyStopped":20,"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":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Overall survival (OS)","time from first antitumor treatment to death from any cause","1year",[14,16],{"measure":15,"description":15,"timeFrame":12},"Progression-free survival (PFS)",{"measure":17,"description":18,"timeFrame":19},"DCR ORR","RECIST 1.1","3MONTH",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":20},"NONE",[28,34],{"label":29,"type":30,"description":31,"interventionNames":32},"IRE + chemotherapy continuation","EXPERIMENTAL","IRE may be performed by open or percutaneous access, based on lesion location, vascular or biliary anatomy, patient condition, and operator judgment. Procedure planning, anesthesia, imaging guidance, perioperative antibiotics, and post-procedure monitoring will follow institutional standards.",[33],"Other: IRE+chemotherapy",{"label":35,"type":36,"description":20,"interventionNames":37},"chemotherapy continuation alone","PLACEBO_COMPARATOR",[38],"Other: chemotherapy",[40,43],{"type":6,"name":41,"description":41,"armGroupLabels":42,"otherNames":20},"IRE+chemotherapy",[29],{"type":6,"name":44,"description":41,"armGroupLabels":45,"otherNames":20},"chemotherapy",[35],[47],{"name":48,"role":49,"phone":50,"phoneExt":20,"email":51},"Huikai Li","CONTACT","18622228639","tjchlhk@126.com",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Tianjin Cancer Hospital Airport Hospital","RECRUITING","Tianjin","Tianjin Municipality","300308","China","CN",{"type":62,"coordinates":63},"Point",[64,65],117.17667,39.14222,{"lat":65,"lon":64},[68],{"name":69,"role":49,"phone":50,"phoneExt":20,"email":51},"Li Huikai, MD",{"type":71,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100653996","hccanano-hope1-ire-after-chemotherapy-for-locally-advanced-unresectable-perihilar-cholangiocarcinoma-100653996",false,"NCT07795619","HCCANANO-HOPE1: IRE After Chemotherapy for Locally Advanced Unresectable Perihilar Cholangiocarcinoma","A Prospective, Randomized Controlled Phase II Clinical Study of Sequential or Non-sequential Irreversible Electroporation After Chemotherapy Induction in Patients With Locally Advanced Unresectable Perihilar Cholangiocarcinoma","Inclusion Criteria:\n\n\\- Age 18-75 years, both sexes\n\nHistologically or cytologically confirmed locally advanced perihilar cholangiocarcinoma (Bismuth-Corlette type III\u002FIV or equivalent)\n\nNon-progressive disease (PR or SD) after 3 cycles of standard induction chemotherapy\n\nMDT-confirmed unresectable disease after induction therapy\n\nNo prior palliative systemic therapy\n\nAt least one measurable lesion per RECIST 1.1\n\nECOG Performance Status 0-1\n\nAdequate organ and marrow function: Hb ≥9.0 g\u002FdL, ANC ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, TBIL ≤3×ULN, AST\u002FALT ≤5×ULN, serum creatinine ≤1.5×ULN or CrCl \\>60 mL\u002Fmin\n\nLife expectancy ≥3 months\n\nWilling to use contraception if of childbearing potential\n\nWritten informed consent\n\nExclusion Criteria:\n\n\\- Refusal to receive systemic chemotherapy or possible surgery\n\nMetastasis to liver, peritoneum, lung, bone, brain, or other distant sites\n\nHistory of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ)\n\nSevere uncontrolled comorbidities (e.g., NYHA III\u002FIV heart failure, unstable angina, uncontrolled arrhythmia, uncontrolled hypertension, active infection, uncontrolled diabetes, significant effusions, severe portal hypertension, gastric outlet obstruction, respiratory insufficiency)\n\nMajor surgery within 30 days before screening\n\nEGFR monoclonal antibody or EGFR-TKI within 30 days before screening\n\nAllergy to any protocol-related drug or component\n\nKnown HIV infection or chronic hepatitis B\u002FC (active)\n\nUnresolved toxicity ≥CTCAE grade 2 from prior treatment (except anaemia, alopecia, skin pigmentation, or chemotherapy-induced neuropathy)\n\nAny condition judged by the investigator to make participation inappropriate","ALL","18 Years","75 Years",{"count":83,"type":84},60,"ESTIMATED","INTERVENTIONAL",[87],"NA","Irreversible electroporation is a non-thermal ablative technology that uses high-voltage electric pulses to create permanent nanopores in tumor cell membranes, leading to apoptosis or other forms of cell death. Because the mechanism is primarily non-thermal, IRE may better preserve extracellular matrix, bile ducts, vessels, and other critical structures than thermal ablation, which is relevant for tumors adjacent to major vascular or biliary anatomy.\n\nThe main anticipated clinical value of IRE in these protocols is local disease control and potential survival benefit when used after induction therapy in patients with non-progressive disease. The procedure may be performed by open or percutaneous access according to tumor location, safety considerations, and institutional expertise. Perioperative management, imaging guidance, and post-procedure monitoring will follow institutional standards.\n\nPost-IRE gastrointestinal dysfunction may occur. Symptom-directed supportive care, including electroacupuncture where appropriate and approved by the investigator, may be used as supportive management. Such care is not intended to replace oncologic treatment and will be recorded as concomitant treatment when administered.",[90],"IRE","2026-08-26",{"date":93,"type":94},"2026-08-31","ACTUAL",{"date":96,"type":94},"2026-04-01",{"date":98,"type":84},"2027-12-31",{"name":5,"class":6},1]