[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627570":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":44,"locations":52,"responsibleParty":67,"collaborators":31,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":31,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":31,"enrollmentInfo":80,"targetDuration":31,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":94,"whyStopped":31,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Jinan Military General Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequential 125I Seed Implantation Followed by Cryoablation","EXPERIMENTAL","Participants receive percutaneous image-guided iodine-125 (125I) seed implantation, followed by image-guided cryoablation within a protocol-defined interval.",[13],"Procedure: Sequential 125I Seed Implantation Followed by Cryoablation",{"label":15,"type":16,"description":17,"interventionNames":18},"125I Seed Implantation Alone","ACTIVE_COMPARATOR","Participants receive standardized percutaneous image-guided iodine-125 (125I) seed implantation alone.",[19],"Procedure: Iodine-125 (125I) Seed Implantation",{"label":21,"type":16,"description":22,"interventionNames":23},"Cryoablation Alone","Participants receive standardized percutaneous image-guided cryoablation alone.",[24],"Procedure: cryoablation",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","Iodine-125 (125I) Seed Implantation","Percutaneous, image-guided implantation of 125I radioactive seeds into the prespecified target lesion(s) according to a protocol-defined treatment plan. Key planning and dosimetric parameters (e.g., prescription dose, target coverage, and organ-at-risk constraints) are recorded per protocol.",[15],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"cryoablation","Percutaneous, image-guided cryoablation of the prespecified target lesion(s) performed using a standardized protocol-defined technique (e.g., applicator placement and freeze-thaw cycles) with documentation of technical success and peri-procedural events per protocol.",[21],{"type":27,"name":9,"description":37,"armGroupLabels":38,"otherNames":31},"Combined sequential local therapy consisting of 125I seed implantation followed by cryoablation within a protocol-defined interval; both procedures are performed under image guidance and documented according to protocol-specified standards.",[9],[40],{"name":41,"affiliation":42,"role":43},"Min Li","The 960th Hospital of People's Liberation Army (PLA)","STUDY_DIRECTOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"Min Li, Dr.","CONTACT","0531-51665482","liminyingxiang.@163.com",{"name":46,"role":47,"phone":31,"phoneExt":31,"email":51},"924787237@qq.com",[53],{"facility":42,"status":31,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Jinan","Shandong","250031","China","CN",{"type":60,"coordinates":61},"Point",[62,63],116.99722,36.66833,{"lat":63,"lon":62},[66],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Li Min","Vice Director","100627570","phase-2-seed-cryo-sequential-125i-seed-implantation-followed-by-cryoablation-vs-single-modality-local-therapy-in-unresectable-solid-tumors-100627570",false,"NCT07450352","SEED-CRYO: Sequential 125I Seed Implantation Followed by Cryoablation vs Single-Modality Local Therapy in Unresectable Solid Tumors","A Randomized Phase II Study of Sequential Iodine-125 Seed Implantation Followed by Cryoablation Versus Iodine-125 Seed Implantation Alone or Cryoablation Alone in Unresectable Solid Tumors","Inclusion Criteria:\n\n* Adults aged ≥18 years;\n* Histologically or cytologically confirmed solid tumor that is unresectable and for which local therapy is clinically appropriate;\n* At least one prespecified target lesion suitable for percutaneous image-guided treatment and considered technically feasible for both 125I seed implantation and cryoablation per investigator assessment (and protocol-defined anatomic\u002Fdosimetric safety criteria);\n* ECOG performance status 0-2;\n* Adequate organ function, acceptable coagulation status, and the ability to safely undergo percutaneous image-guided procedures;\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* Prior 125I seed implantation or cryoablation to the same target lesion(s), or other local therapy to the target lesion(s);\n* Target lesion location or anatomy that, in the investigator's judgment, makes either procedure unsafe or unlikely to achieve protocol-defined coverage\u002Fablation (e.g., inability to meet organ-at-risk constraints or required safety margins);\n* Uncontrolled bleeding risk or coagulopathy not correctable per protocol; inability to safely hold\u002Fbridge anticoagulants\u002Fantiplatelets as required.\n\nActive, uncontrolled infection, including uncontrolled local infection at the intended procedure site;\n\n* Clinically significant uncontrolled comorbidities that increase procedural risk;\n* Severe organ dysfunction that precludes procedures or follow-up, per protocol-defined thresholds.;\n* Pregnancy or breastfeeding;\n* Known hypersensitivity to materials\u002Fmedications essential for the procedures (e.g., contrast agents or anesthetics) that cannot be adequately managed;\n* Any condition that would impair reliable outcome assessment or adherence (e.g., inability to undergo required imaging, expected poor compliance), per investigator judgment.","ALL","18 Years",{"count":81,"type":82},150,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","This open-label, randomized Phase II trial evaluates whether sequential iodine-125 seed implantation followed by cryoablation improves local tumor control versus single-modality local therapy (125I seeds alone or cryoablation alone) in unresectable solid tumors.\n\nThe study is based on a complementary treatment rationale: cryoablation provides rapid cytoreduction of the dominant tumor component, while 125I seed brachytherapy delivers sustained low-dose-rate irradiation that may better suppress residual viable tumor at the periphery and microscopic extension zones. The trial is designed to determine whether this spatial and temporal complementarity translates into superior local disease control without unacceptable toxicity.\n\nParticipants will be randomized in parallel to one of three arms: (1) sequential 125I seed implantation followed by cryoablation within a protocol-defined interval, (2) 125I seed implantation alone, or (3) cryoablation alone. Treatment assignment is open label; imaging-based efficacy endpoints will be assessed using a standard blinded assessment process (blinded evaluators), according to protocol-defined criteria.\n\nThe primary endpoint is local control rate (LCR) of prespecified target lesions and progression-free survival (PFS). Key secondary endpoints are local progression-free survival (LPFS), overall survival (OS), early pain response, technical success, target-lesion re-intervention rate, and safety (including grade ≥3 treatment-emergent adverse events, CTCAE v5.0). Exploratory analyses include dosimetry-outcome associations, imaging\u002Fradiomics biomarkers, and peripheral blood biomarker dynamics.",[88],"Unresectable Solid Tumors",[90,91,92,93],"Unresectable solid tumors","Iodine-125 seed implantation","Cryoablation","Sequential local therapy","NOT_YET_RECRUITING","2026-02-27",{"date":97,"type":98},"2026-03-04","ACTUAL",{"date":100,"type":82},"2026-02",{"date":102,"type":82},"2028-07-01",{"name":69,"class":6},1]