[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626591":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":64,"studyPopulation":60,"armGroups":65,"interventions":79,"overallOfficials":93,"centralContacts":98,"locations":106,"responsibleParty":121,"collaborators":60,"id":125,"slug":60,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":60,"eligibilityCriteria":130,"healthyVolunteers":126,"sex":131,"minAge":132,"maxAge":60,"enrollmentInfo":133,"targetDuration":60,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":150,"whyStopped":60,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Jinan Military General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":43},[9,13],{"measure":10,"description":11,"timeFrame":12},"Local Control Rate (LCR) of Treated Target Lesions","Proportion of prespecified treated target lesions without local progression by blinded independent imaging review per protocol-defined criteria.","6 months after completion of protocol local therapy",{"measure":14,"description":15,"timeFrame":16},"Local Progression-Free Survival (LPFS) of the Bulky Index Lesion","Time from randomization to local progression of the prespecified bulky index lesion or death from any cause, whichever occurs first, assessed by blinded independent imaging review.","Up to 12 months",[18,21,25,28,32,36,40],{"measure":19,"description":20,"timeFrame":16},"Progression-Free Survival (PFS)","Time from randomization to radiographic disease progression (including new lesions) or death from any cause, whichever occurs first (RECIST v1.1, blinded independent review when applicable).",{"measure":22,"description":23,"timeFrame":24},"Overall Response Rate (ORR)","Proportion of participants achieving complete response or partial response at the patient level per RECIST v1.1.","First assessment at ~8-12 weeks; up to 6 months",{"measure":26,"description":27,"timeFrame":16},"Time to Systemic Progression","Time from randomization to systemic progression, including appearance of new lesions and\u002For progression of non-target\u002Fnon-treated disease per protocol criteria.",{"measure":29,"description":30,"timeFrame":31},"Overall Survival (OS)","Time from randomization to death from any cause.","Up to 24 months",{"measure":33,"description":34,"timeFrame":35},"Tumor-Burden Reduction","Change from baseline in sum of diameters of measurable disease (RECIST) and\u002For total measurable tumor volume for the bulky index lesion (volumetric imaging) per protocol.","Baseline to 3 months and 6 months",{"measure":37,"description":38,"timeFrame":39},"Technical Success (Procedure-Level)","Successful completion of the assigned procedure(s) per protocol (e.g., planned seed placement\u002Fcoverage or planned ablation zone achieved) without immediate major protocol deviation.","Day of procedure to 7 days post-procedure",{"measure":41,"description":42,"timeFrame":16},"Re-intervention Rate of Treated Target Lesions","Proportion of treated target lesions requiring repeat local intervention due to local progression or incomplete control per protocol.",[44,48,52],{"measure":45,"description":46,"timeFrame":47},"Zonal Response of Bulky Index Lesion","Core versus peripheral\u002Fhigh-risk margin response of the bulky index lesion assessed by volumetric and\u002For functional imaging (e.g., necrosis fraction, enhancement change, metabolic response when available) and its association with LPFS.","Baseline to 8-12 weeks and 6 months",{"measure":49,"description":50,"timeFrame":51},"Peripheral Blood Biomarker Dynamics","Longitudinal changes in blood-based biomarkers (e.g., inflammatory indices, cytokines\u002Fimmune subsets per site capability) and their associations with local control and systemic progression.","Baseline; post-procedure\u002Fearly follow-up (~2-4 weeks); then through 6-12 months",{"measure":53,"description":54,"timeFrame":16},"Patterns of Failure","Site and type of first progression (treated lesion vs untreated lesion vs new lesion), and spatial pattern of recurrence within bulky lesions (core vs margin) when assessable.",{"allocation":56,"interventionModel":57,"interventionModelDescription":58,"primaryPurpose":59,"observationalModel":60,"timePerspective":60,"maskingInfo":61},"RANDOMIZED","PARALLEL","This strategy-based local therapy model uses (1) lesion allocation of prespecified metastatic targets to either 125I seed implantation or cryoablation using predefined suitability criteria, and (2) tumor-zoned treatment of a bulky index lesion (core debulking plus peripheral\u002Fhigh-risk margin control) under organ-at-risk constraints, compared with single-modality local therapy for all target lesions.","TREATMENT",null,{"masking":62,"maskingDescription":63,"whoMasked":60},"NONE","Due to the procedural nature of 125I seed implantation and cryoablation, blinding of participants and treating clinicians is not feasible; therefore, the study is open label. However, imaging evaluators-including independent radiologists and nuclear medicine physicians responsible for tumor response assessment and imaging-based efficacy evaluations-will remain blinded to treatment allocation, with adjudication when necessary to minimize assessment bias.","This open-label, randomized Phase II trial evaluates whether a strategy-based, multimodal local treatment approach can improve local control and disease outcomes compared with single-modality local therapy in patients with high-burden metastatic disease. The trial targets a population in which tumor burden is driven by both multiple metastatic deposits and at least one bulky lesion, where uniform local treatment is often limited by anatomic heterogeneity, safety constraints, and incomplete coverage of high-risk tumor regions.\n\nThe study is based on a complementary rationale at both the inter-lesion and intra-lesion levels. For multiple metastases, different lesions may be optimally treated with different modalities: cryoablation offers rapid cytoreduction and prompt symptom relief in appropriately accessible lesions with favorable safety margins, while iodine-125 (125I) seed implantation provides sustained low-dose-rate irradiation that can better sterilize residual disease in lesions where ablative margins are difficult to achieve or where durable peripheral control is prioritized. For bulky tumors, a tumor-zoned concept is applied to address intratumoral heterogeneity and margin risk: the core region is treated to achieve efficient debulking (typically with cryoablation), while the peripheral\u002Fhigh-risk margin zones are treated to enhance durable control (typically with 125I seeds) under protocol-defined organ-at-risk constraints. The trial is designed to determine whether this structured \"allocation plus zoning\" strategy translates into superior local disease control and meaningful tumor-burden reduction without unacceptable toxicity.\n\nParticipants will be randomized in parallel to one of two arms: (1) strategy-based combined local therapy, consisting of protocol-defined lesion allocation (each prespecified metastatic target lesion assigned to 125I seed implantation or cryoablation based on predefined anatomic\u002Ftechnical suitability criteria) plus tumor-zoned treatment for at least one prespecified bulky index lesion; or (2) single-modality local therapy, in which all prespecified target lesions are treated using a single local modality (either 125I seed implantation alone or cryoablation alone, as specified by the protocol and\u002For center capability) with standard supportive care. Treatment assignment is open label. To reduce assessment bias, imaging-based efficacy endpoints will be evaluated using a standardized blinded imaging review process by independent assessors according to protocol-defined criteria, with prespecified rules for target lesion selection, timing windows, and adjudication of progression events.\n\nThe primary endpoint is local control rate (LCR) of prespecified treated target lesions at a fixed time point and local progression-free survival (LPFS) of the bulky index lesion (as defined in the protocol). Key secondary endpoints include progression-free survival (PFS), overall response rate (ORR) (patient-level by RECIST), time to systemic progression (including appearance of new lesions), overall survival (OS), tumor-burden reduction metrics (e.g., change in sum of diameters and\u002For total measurable tumor volume), technical success rates for each procedure, need for re-intervention on treated target lesions.\n\nSafety will be assessed throughout the study and includes procedure-related and radiation-related adverse events graded by CTCAE v5.0, with focused monitoring for clinically relevant risks such as bleeding, infection, fistula\u002Forgan injury, nerve or vascular injury, cryo-related complications, seed migration, radiation injury to adjacent organs, and any grade ≥3 treatment-emergent adverse events. Prespecified dose planning and procedural quality assurance measures will be implemented for 125I seed implantation, and standardized cryoablation parameters and post-procedure imaging checks will be used to ensure consistent delivery and safety oversight. Exploratory analyses will evaluate dosimetry-outcome relationships (e.g., coverage and dose-volume parameters for seed implants), zonal treatment response patterns within bulky lesions, imaging biomarkers and radiomics features associated with benefit, and the dynamics of peripheral blood biomarkers as potential correlates of local control and systemic progression.",[66,72],{"label":67,"type":68,"description":69,"interventionNames":70},"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.",[71],"Other: Lesion Allocation and Tumor Zoning Strategy",{"label":73,"type":74,"description":75,"interventionNames":76},"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.",[77,78],"Procedure: Iodine-125 (125I) Seed Implantation (Low-Dose-Rate Brachytherapy)","Procedure: cryoablation",[80,85,89],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":60},"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.",[73],{"type":81,"name":86,"description":87,"armGroupLabels":88,"otherNames":60},"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.",[73],{"type":6,"name":90,"description":91,"armGroupLabels":92,"otherNames":60},"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.",[67],[94],{"name":95,"affiliation":96,"role":97},"Min Li","The 960th Hospital of People's Liberation Army (PLA)","STUDY_DIRECTOR",[99,104],{"name":100,"role":101,"phone":102,"phoneExt":60,"email":103},"Min Li, Dr.","CONTACT","0531-51665482","liminyingxiang.@163.com",{"name":100,"role":101,"phone":60,"phoneExt":60,"email":105},"924787237@qq.com",[107],{"facility":96,"status":60,"city":108,"state":109,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":118,"contacts":119},"Jinan","Shandong","250031","China","CN",{"type":114,"coordinates":115},"Point",[116,117],116.99722,36.66833,{"lat":117,"lon":116},[120],{"name":100,"role":101,"phone":102,"phoneExt":60,"email":103},{"type":122,"investigatorFullName":123,"investigatorTitle":124,"investigatorAffiliation":5,"oldNameTitle":60,"oldOrganization":60},"SPONSOR_INVESTIGATOR","Li Min","Vice Director","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":134,"type":135},90,"ESTIMATED","INTERVENTIONAL",[138],"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.",[141],"High-Burden Metastatic Solid Tumors",[143,144,145,146,147,148,149],"Iodine-125 seed implantation","Cryoablation","High tumor burden","Multiple metastases","Lesion allocation","Tumor zoning","Local control","NOT_YET_RECRUITING","2026-02-22",{"date":153,"type":154},"2026-02-27","ACTUAL",{"date":156,"type":135},"2026-02",{"date":158,"type":135},"2028-07-01",{"name":123,"class":6},1]