[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626591":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":41,"locations":49,"responsibleParty":64,"collaborators":27,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":27,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":27,"enrollmentInfo":77,"targetDuration":27,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":94,"whyStopped":27,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Jinan Military General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lesion-Allocated + Tumor-Zoned Combined Local Therapy (125I Seeds + Cryoablation)","EXPERIMENTAL","Participants receive strategy-based multimodal local therapy. Prespecified metastatic target lesions are prospectively allocated to either iodine-125 (125I) seed implantation or cryoablation according to protocol-defined anatomic and technical suitability criteria. In addition, at least one bulky index lesion is treated using a tumor-zoned approach (e.g., core debulking with cryoablation and peripheral\u002Fhigh-risk margin control with \\^125I seeds) under predefined organ-at-risk constraints. Standardized follow-up and supportive care are provided per protocol.",[13],"Other: Lesion Allocation and Tumor Zoning Strategy",{"label":15,"type":16,"description":17,"interventionNames":18},"Single-Modality Local Therapy (Cryoablation Alone or ^125I Seeds Alone)","ACTIVE_COMPARATOR","Participants receive single-modality local therapy for all prespecified target lesions, using either cryoablation alone or iodine-125 (125I) seed implantation alone as specified by the protocol and\u002For center capability, with standardized supportive care and follow-up. Imaging-based efficacy endpoints are assessed per protocol with standardized blinded independent review.",[19,20],"Procedure: Iodine-125 (125I) Seed Implantation (Low-Dose-Rate Brachytherapy)","Procedure: cryoablation",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Iodine-125 (125I) Seed Implantation (Low-Dose-Rate Brachytherapy)","Image-guided percutaneous implantation of 125I radioactive seeds into prespecified target lesions according to protocol-defined treatment planning and organ-at-risk constraints. Seed number and distribution are determined by pre-implant planning to achieve protocol-specified target coverage, with post-implant verification imaging and dosimetry as required.",[15],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"cryoablation","Image-guided percutaneous cryoablation of prespecified target lesions using standardized probe placement and freeze-thaw cycles per protocol. The ablation zone is planned to achieve protocol-defined tumor coverage while maintaining safety margins to adjacent critical structures, with intraprocedural monitoring and post-procedure imaging assessment.",[15],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Lesion Allocation and Tumor Zoning Strategy","Protocol-defined decision rules assign each prespecified metastatic target lesion to 125I seed implantation or cryoablation based on anatomic and technical suitability criteria. For at least one bulky index lesion, a tumor-zoned approach is applied (e.g., core debulking with cryoablation and peripheral\u002Fhigh-risk margin control with 125I seeds) under predefined organ-at-risk constraints and quality assurance requirements.",[9],[37],{"name":38,"affiliation":39,"role":40},"Min Li","The 960th Hospital of People's Liberation Army (PLA)","STUDY_DIRECTOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},"Min Li, Dr.","CONTACT","0531-51665482","liminyingxiang.@163.com",{"name":43,"role":44,"phone":27,"phoneExt":27,"email":48},"924787237@qq.com",[50],{"facility":39,"status":27,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Jinan","Shandong","250031","China","CN",{"type":57,"coordinates":58},"Point",[59,60],116.99722,36.66833,{"lat":60,"lon":59},[63],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Li Min","Vice Director","100626591","phase-2-lesion-allocated-therapy-for-multiple-metastases-and-tumor-zoned-treatment-for-bulky-tumors-a-phase-ii-study-of-iodine-125-seed-implantation-combined-with-cryoablation-in-high-burden-metastatic-disease-100626591",false,"NCT07437625","Lesion-Allocated Therapy for Multiple Metastases and Tumor-Zoned Treatment for Bulky Tumors: A Phase II Study of Iodine-125 Seed Implantation Combined With Cryoablation in High-Burden Metastatic Disease","A Multicenter, Open-Label, Randomized Phase II Trial of Lesion-Allocated Iodine-125 Seed Implantation Combined With Cryoablation for Multiple Metastases and Tumor-Zoned Local Therapy for Bulky Tumors in Patients With High-Burden Metastatic Disease","Inclusion Criteria:\n\n* Age ≥18 years;\n* Histologically or cytologically confirmed solid malignancy with metastatic disease not amenable to curative surgery or definitive curative-intent radiotherapy;\n* High-burden metastatic disease, defined as: Multiple metastases: ≥3 metastatic lesions on imaging, and at least 2 measurable lesions (RECIST v1.1) planned as protocol target lesions; and Bulky lesion: at least 1 lesion meeting bulky criteria (e.g., longest diameter ≥7 cm or tumor volume ≥100 mL, per protocol) designated as the bulky index lesion;\n* At least 2 and up to 5 prespecified target lesions are suitable for protocol local therapy and can be assigned per protocol (lesion allocation and\u002For tumor zoning);\n* ECOG performance status 0-2;\n* Adequate organ function;\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Lesions requiring emergent surgical decompression or other urgent intervention that cannot be deferred to protocol timelines;\n* Target lesions not safely accessible for percutaneous cryoablation and\u002For 125I seed implantation (e.g., no feasible needle path, unacceptable risk to critical structures despite protective maneuvers);\n* Active, uncontrolled infection; uncontrolled pleural effusion\u002Fascites requiring frequent drainage (unless stabilized);\n* Severe cardiopulmonary comorbidity prohibiting anesthesia\u002Fsedation or percutaneous intervention (e.g., unstable angina, recent MI, uncontrolled arrhythmia, severe COPD with high oxygen requirement);\n* Prior local therapy to the same bulky index lesion that would confound response assessment (prior treatment to other non-index lesions may be allowed);\n* Uncontrolled CNS metastases (symptomatic, requiring escalating steroids, or not stable after local therapy). Stable treated brain metastases may be allowed per protocol;\n* Any condition that, in the investigator's judgment, would compromise protocol compliance or make participation unsafe.","ALL","18 Years",{"count":78,"type":79},90,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","This open-label, randomized Phase II trial evaluates whether a strategy-based, multimodal local treatment approach improves local control compared with single-modality local therapy in patients with high-burden metastatic disease characterized by multiple metastases and at least one bulky lesion.\n\nIn the experimental arm, prespecified target lesions are prospectively allocated to either iodine-125 (125I) seed implantation or cryoablation using protocol-defined anatomic and technical suitability criteria, and at least one bulky index lesion is treated using a tumor-zoned approach (e.g., core debulking with cryoablation and peripheral\u002Fhigh-risk margin control with 125I seeds) under predefined organ-at-risk constraints. The control arm treats all prespecified target lesions with a single local modality (either 125I seed implantation alone or cryoablation alone), with standardized supportive care and follow-up.\n\nThe primary objective is to determine whether the \"lesion allocation plus tumor zoning\" strategy can improve local control of treated target lesions with acceptable safety. Imaging-based efficacy endpoints are evaluated using protocol-defined criteria with standardized blinded independent imaging review. Key secondary endpoints include local progression-free survival of the bulky index lesion, overall response rate (RECIST), progression-free survival, time to systemic progression (including new lesions), overall survival, tumor-burden reduction metrics, technical success, and re-intervention rates. Safety is assessed throughout the study using CTCAE v5.0, including monitoring for procedure-related and radiation-related complications. Exploratory analyses assess dosimetry-outcome relationships, zonal response patterns within bulky lesions, imaging\u002Fradiomics biomarkers, and peripheral blood biomarker dynamics.",[85],"High-Burden Metastatic Solid Tumors",[87,88,89,90,91,92,93],"Iodine-125 seed implantation","Cryoablation","High tumor burden","Multiple metastases","Lesion allocation","Tumor zoning","Local control","NOT_YET_RECRUITING","2026-02-22",{"date":97,"type":98},"2026-02-27","ACTUAL",{"date":100,"type":79},"2026-02",{"date":102,"type":79},"2028-07-01",{"name":66,"class":6},1]