[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-burden-metastatic-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-burden-metastatic-solid-tumors":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"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":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"High-Burden Metastatic Solid Tumors",[28,29,30,31,32,33,34],"Iodine-125 seed implantation","Cryoablation","High tumor burden","Multiple metastases","Lesion allocation","Tumor zoning","Local control","NOT_YET_RECRUITING","2026-02-22",{"date":38,"type":39},"2026-02-27","ACTUAL",{"date":41,"type":20},"2026-02",{"date":43,"type":20},"2028-07-01",{"name":45,"class":46},"Li Min","OTHER"]