[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618595":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":24,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":24,"enrollmentInfo":66,"targetDuration":24,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":79,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Jinan Military General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard-of-Care Systemic Therapy","ACTIVE_COMPARATOR","Participants receive standard-of-care systemic anticancer therapy according to current clinical guidelines and treating physician discretion.",[13],"Other: Standard-of-Care Systemic Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"125I Seed Implantation plus Standard-of-Care Systemic Therapy","EXPERIMENTAL","Participants receive image-guided iodine-125 (125I) seed implantation to multiple metastatic lesions in combination with standard-of-care systemic anticancer therapy.",[13,19],"Procedure: Iodine-125 (125I) Seed Implantation",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Systemic anticancer therapy administered according to current clinical guidelines and treating physician discretion, which may include chemotherapy, immunotherapy, targeted therapy, and\u002For maintenance therapy.",[15,9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"PROCEDURE","Iodine-125 (125I) Seed Implantation","Image-guided implantation of iodine-125 (125I) radioactive seeds to multiple metastatic lesions for local tumor control, performed under CT guidance (with PET\u002FCT fusion planning when clinically indicated) according to institutional standards.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Min Li, M.D.","CONTACT","0531-51665482","liminyingxiang.@163.com",[37],{"facility":38,"status":24,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The 960th Hospital of People's Liberation Army (PLA)","Jinan","Shandong","250031","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.99722,36.66833,{"lat":48,"lon":47},[51],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":52},"liminyingxiang@163.com",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Li Min","Vice Director","100618595","phase-2-image-guided-125i-seed-implantation-plus-standard-systemic-therapy-for-patients-with-multiple-metastatic-lesions-100618595",false,"NCT07333664","Image-Guided 125I Seed Implantation Plus Standard Systemic Therapy for Patients With Multiple Metastatic Lesions","Standard-of-Care Systemic Therapy With or Without Image-Guided 125I Seed Implantation in Patients With Multiple (6-10) Metastatic Lesions: A Randomized Phase 2 Study","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed malignant solid tumor with metastatic disease.\n* Presence of more than five and up to ten (6-10) extracranial metastatic lesions, identified on CT or PET\u002FCT imaging and assessable by RECIST version 1.1 (and\u002For PERCIST when PET imaging is used).\n* At least one metastatic lesion considered suitable for image-guided iodine-125 (125I) seed implantation according to institutional assessment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Adequate organ function to undergo interventional procedures and systemic therapy, as determined by institutional standards.\n* Ability to understand and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Diffuse or unstable central nervous system involvement, including leptomeningeal disease or uncontrolled\u002Fsymptomatic brain metastases requiring immediate local intervention.\n* Medical conditions that preclude safe interventional procedures, including uncontrolled infection, severe cardiopulmonary dysfunction, or other serious systemic illness, as judged by the investigator.\n* Contraindications to percutaneous implantation, such as uncorrectable coagulation disorders, high bleeding risk, lack of a safe needle path, or unacceptable risk to critical organs.\n* Pregnancy or breastfeeding.\n* Inability to provide informed consent or comply with study procedures, due to severe psychiatric illness, cognitive impairment, or other limiting conditions.\n* Any other condition that, in the investigator's judgment, would make the patient unsuitable for study participation or compromise patient safety or study integrity.","ALL","18 Years",{"count":67,"type":68},120,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","Patients with more than five and up to ten metastatic lesions often have limited tolerance for surgery, radiotherapy, or thermal ablation because of cumulative treatment burden or expected toxicity. In this setting, systemic therapy alone frequently remains the primary treatment option.\n\nThis prospective, open-label, randomized phase 2 study evaluates whether image-guided iodine-125 (125I) seed implantation, when added to standard-of-care systemic therapy, can improve disease control compared with standard systemic therapy alone in patients with multiple metastatic lesions. Clinical outcomes including progression-free survival, overall survival, safety, and quality of life will be prospectively assessed.",[74],"Metastatic Solid Tumors",[76,77,78],"Multiple Metastases","lodine-125 Seed Brachytherapy","Image-Guided Therapy","NOT_YET_RECRUITING","2026-01-02",{"date":82,"type":83},"2026-01-12","ACTUAL",{"date":85,"type":68},"2026-01",{"date":87,"type":68},"2028-01-01",{"name":55,"class":6},1]