[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Li Min\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":184},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,45,69,94,118,138,159],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Unresectable Solid Tumors",[28,29,30,31],"Unresectable solid tumors","Iodine-125 seed implantation","Cryoablation","Sequential local therapy","NOT_YET_RECRUITING","2026-02-27",{"date":35,"type":36},"2026-03-04","ACTUAL",{"date":38,"type":20},"2026-02",{"date":40,"type":20},"2028-07-01",{"name":42,"class":43},"Li Min","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":68,"locationsCount":44},"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","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.",{"count":53,"type":20},90,[23],"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.",[57],"High-Burden Metastatic Solid Tumors",[29,30,59,60,61,62,63],"High tumor burden","Multiple metastases","Lesion allocation","Tumor zoning","Local control","2026-02-22",{"date":33,"type":36},{"date":38,"type":20},{"date":40,"type":20},{"name":42,"class":43},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":44},"100618594","phase-2-125i-seed-implantation-plus-systemic-therapy-for-oligoprogressive-nsclc-or-colorectal-cancer-100618594","NCT07333651","125I Seed Implantation Plus Systemic Therapy for Oligoprogressive NSCLC or Colorectal Cancer","Standard-of-Care Systemic Therapy With or Without Image-Guided 125I Seed Implantation in Patients With Oligoprogressive Metastatic Non-Small Cell Lung Cancer or Colorectal Cancer: An Open-Label, Randomized, Controlled Phase 2 Study","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed metastatic non-small cell lung cancer (NSCLC) or colorectal cancer (CRC).\n* Presence of metastatic disease with extracranial oligoprogression, defined as progression in up to five (≤5) individual lesions on CT or PET\u002FCT imaging, while other known disease sites remain stable or controlled.\n* Received at least one prior line of standard systemic anticancer therapy, including maintenance therapy, for metastatic disease.\n* All oligoprogressive lesions are technically feasible and considered safe for image-guided 125I seed implantation, as determined by the treating interventional team.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Adequate organ function to undergo interventional procedures and systemic therapy, per institutional standards.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Leptomeningeal disease or diffuse central nervous system involvement. Uncontrolled infection or serious medical comorbidities that, in the investigator's judgment, would preclude safe participation or interventional procedures.\n* Prior radiotherapy or brachytherapy requiring re-irradiation to the same tumor location planned for 125I seed implantation.\n* Known bleeding diathesis or uncorrectable coagulation disorders contraindicating interventional procedures.\n* Any other condition that, in the investigator's judgment, would make the patient unsuitable for the study.",{"count":53,"type":20},[23],"Most patients with metastatic cancer eventually develop resistance to systemic therapy. A subset of patients experience oligoprogression, characterized by progression at a limited number of lesions while other disease sites remain controlled by ongoing systemic therapy. This randomized phase 2 trial evaluates whether image-guided 125I seed implantation targeting all oligoprogressive extracranial lesions, combined with standard-of-care systemic therapy, improves progression-free survival compared with standard-of-care systemic therapy alone in patients with metastatic NSCLC or CRC.",[80],"Oligometastatic Disease",[82,83,84,85],"lodine-125 Seed Brachytherapy","Oligoprogression","Non-Small Cell Lung Cancer","Colorectal Cancer","2026-01-02",{"date":88,"type":36},"2026-01-12",{"date":90,"type":20},"2026-01",{"date":92,"type":20},"2028-01-01",{"name":42,"class":43},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":115,"leadSponsor":117,"locationsCount":44},"100618122","petct-guided-biological-target-volume-delineation-and-dose-optimization-for-radioactive-seed-implantation-therapy-in-malignant-tumors-100618122","NCT07327515","PET\u002FCT-Guided Biological Target Volume Delineation and Dose Optimization for Radioactive Seed Implantation Therapy in Malignant Tumors","A Phase I\u002FII Study of PET\u002FCT-Guided Biological Target Volume Delineation and Dose Optimization for Radioactive Seed Implantation Therapy in Malignant Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Pathologically or clinically confirmed malignant tumor (solid tumor, lymphoma, or leukemia with a localized lesion suitable for radioactive seed implantation).\n3. Tumor site accessible for image-guided implantation, with a target lesion visible on CT or PET\u002FCT.\n4. Life expectancy of at least 6 months.\n5. Ability to undergo PET\u002FCT imaging (FDG or tumor-specific tracers such as PSMA or FAPI).\n6. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. Uncontrolled infection or active systemic inflammatory disease.\n3. Severe cardiopulmonary dysfunction that contraindicates interventional procedures (e.g., heart failure, severe COPD).\n4. Coagulation disorders (INR \\> 1.5 or platelet count \\\u003C 50 × 10⁹\u002FL).\n5. Known allergy or intolerance to radiopharmaceuticals or iodinated contrast media.\n6. Prior radiation therapy overlapping with the planned implantation area.\n7. Participation in another clinical trial within the past 30 days that may interfere with study results.\n8. Any medical or psychosocial condition considered unsuitable for study participation by the investigators (e.g., poor compliance, unstable clinical status).",{"count":53,"type":20},[103],"NA","This prospective, open-label Phase I\u002FII trial evaluates a PET\u002FCT-guided planning strategy for radioactive seed implantation therapy in malignant solid tumors. The approach integrates metabolic information from PET\u002FCT into brachytherapy planning to improve the accuracy of biological target volume delineation, enhance dose coverage, and support biologically informed dose delivery. Eligible participants are assigned to one of three arms: conventional CT-guided implantation, PET\u002FCT-guided standard-dose implantation, or PET\u002FCT-guided biologically optimized implantation. All participants undergo image-guided treatment followed by post-implant dosimetric verification and standardized clinical follow-up.\n\nPrimary endpoints include technical success rate, dosimetric superiority, and 6-month local control. Secondary endpoints include dosimetric indices (D90, V100, conformity index, homogeneity index), pain relief, quality of life (EORTC QLQ-C30), treatment-related adverse events (CTCAE v5.0), progression-free survival (PFS), failure-free survival (FFS), and overall survival (OS). Exploratory analyses will evaluate associations between baseline PET metabolic parameters (SUVmax, metabolic tumor volume) and clinical outcomes, assess the feasibility of SUV-guided dose painting, and compare the performance of tumor-specific tracers (such as PSMA and FAPI) with FDG for target delineation and treatment response prediction.\n\nThe central hypothesis is that PET\u002FCT-guided planning-particularly when incorporating biological dose optimization-will achieve superior dosimetric performance and improved local control and survival outcomes compared with conventional CT-guided implantation.",[106],"Malignant Tumors",[108,109,110,111],"PET\u002FCT-Guided Brachytherapy","Iodine-125 Seed Implantation","Molecular Imaging-Guided Therapy","Biology-Guided Dose Planning",{"date":113,"type":36},"2026-01-08",{"date":90,"type":20},{"date":116,"type":20},"2028-06-01",{"name":42,"class":43},{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":136,"leadSponsor":137,"locationsCount":44},"100618595","phase-2-image-guided-125i-seed-implantation-plus-standard-systemic-therapy-for-patients-with-multiple-metastatic-lesions-100618595","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.",{"count":126,"type":20},120,[23],"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.",[130],"Metastatic Solid Tumors",[132,82,133],"Multiple Metastases","Image-Guided Therapy",{"date":88,"type":36},{"date":90,"type":20},{"date":92,"type":20},{"name":42,"class":43},{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":157,"leadSponsor":158,"locationsCount":44},"100614298","phase-2-125i-seed-brachytherapy-combined-with-immunotherapy-for-primary-recurrent-or-metastatic-malignant-tumors-100614298","NCT07277777","125I Seed Brachytherapy Combined With Immunotherapy for Primary, Recurrent, or Metastatic Malignant Tumors","A Prospective, Randomized, Open-Label, Parallel-Group Clinical Trial Evaluating the Efficacy and Safety of 125I Seed Interstitial Brachytherapy Combined With Immune Checkpoint Inhibitor Therapy in Patients With Primary, Recurrent, or Metastatic Malignant Tumors Compared With Immune Checkpoint Inhibitor Therapy Alone","Inclusion Criteria:\n\n* Age 18 to 80 years.\n* Histologically or clinically confirmed primary, recurrent, or metastatic malignant tumor.\n* At least one measurable lesion according to RECIST 1.1 or iRECIST.\n* Tumor site suitable for 125I seed implantation under CT or PET\u002FCT guidance.\n* Planned to receive or eligible to receive an immune checkpoint inhibitor (ICI).\n* ECOG performance status 0-2.\n* Adequate organ function:\n\nANC ≥ 1.5 × 10⁹\u002FL Platelets ≥ 80 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL AST\u002FALT ≤ 3 × ULN (≤ 5 × ULN for liver metastasis) Creatinine clearance ≥ 50 mL\u002Fmin\n\n* Life expectancy ≥ 3 months.\n* Ability to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Prior I-125 seed implantation at the planned treatment site.\n* Active uncontrolled infection or systemic inflammatory disease.\n* Known history of autoimmune disease requiring systemic immunosuppression.\n* Prior treatment with immune checkpoint inhibitors within the last 4 weeks.\n* Uncontrolled coagulopathy or contraindication to interventional seed implantation:\n\nINR \\> 1.5 Platelets \\\u003C 50 × 10⁹\u002FL\n\n* Tumor location that poses unacceptable procedural risk, including inability to obtain a safe puncture path.\n* Severe cardiopulmonary dysfunction (e.g., heart failure, unstable arrhythmia, severe COPD).\n* Pregnancy or breastfeeding.\n* Known allergy or contraindication to radiopharmaceuticals, contrast agents, or anesthesia agents used during implantation.\n* Any condition that, in the investigator's judgment, makes the participant unsuitable for the study (e.g., poor compliance, severe psychiatric disorder).","80 Years",{"count":53,"type":20},[23],"This prospective randomized trial evaluates the efficacy and safety of combining 125I seed interstitial brachytherapy with immune checkpoint inhibitor therapy in patients with primary, recurrent, or metastatic malignant tumors. Immunotherapy has become an important systemic treatment option, yet many patients experience limited benefit due to low tumor immunogenicity, insufficient T-cell infiltration, and an immunosuppressive tumor microenvironment.\n\n125I seed brachytherapy provides continuous low-dose-rate radiation to the tumor, promoting antigen release, enhancing dendritic cell activation, and potentially converting immunologically \"cold\" tumors into more responsive \"hot\" lesions. Integrating localized radiation with systemic immunotherapy may improve tumor response, prolong progression-free survival, and reduce recurrence.\n\nPatients will be randomized 1:1 to receive 125I seed implantation plus immunotherapy or immunotherapy alone. The primary endpoints are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include failure-free survival (FFS), overall survival (OS), disease control rate (DCR), duration of response (DoR), local control, recurrence rate, adverse events, and quality of life. Exploratory analyses will assess radiomics features, subgroup responses, and different patterns of recurrence. This study aims to determine whether adding 125I seed brachytherapy enhances the clinical benefits of immunotherapy across diverse malignant tumors.",[106],[82,151,152,153],"Immune Checkpoint Inhibitors","Local-Systemic Synergy","Recurrent or Refractory Tumors",{"date":155,"type":36},"2026-01-06",{"date":90,"type":20},{"date":92,"type":20},{"name":42,"class":43},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":171,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":44},"100606164","research-on-the-optimization-of-treatment-for-spinal-metastases-with-radioactive-particle-implantation-using-tps-and-mechanical-dual-simulation-100606164","NCT07171996","Research on the Optimization of Treatment for Spinal Metastases With Radioactive Particle Implantation Using TPS and Mechanical Dual Simulation","Inclusion Criteria:\n\n* Age ≥18 years.\n\nRadiologically or histologically confirmed bone metastasis with a lesion suitable for percutaneous radioactive seed implantation (e.g., I-125), per multidisciplinary assessment.\n\nIndication for local palliation\u002Fcontrol: moderate-to-severe pain at lesion (e.g., BPI\u002FVAS ≥4) and\u002For imaging evidence of progression or high-risk features warranting local therapy.\n\nMeasurable\u002Fevaluable target lesion on CT\u002FMRI; target location accessible for needle placement per institutional practice.\n\nECOG performance status 0-2.\n\nEstimated life expectancy ≥3 months.\n\nAdequate hemostasis: platelets ≥80×10\\^9\u002FL, INR ≤1.5 (or per protocol), and able to hold\u002Fbridge anticoagulation as clinically indicated.\n\nAdequate organ function to undergo the procedure and anesthesia\u002Fsedation per site standards.\n\nAble to undergo required imaging (CT; MRI if applicable).\n\nWilling and able to provide written informed consent and comply with follow-up.\n\nFor women of childbearing potential and men with partners of childbearing potential: agreement to use effective contraception during and for the protocol-defined period after implantation.\n\nExclusion Criteria:\n\n* Need for urgent surgical decompression or stabilization (e.g., acute\u002Fimpending neurologic compromise, unstable pathologic fracture) that precludes percutaneous implantation at this time.\n\nUncorrected coagulopathy or ongoing antithrombotic therapy that cannot be safely managed periprocedurally.\n\nActive systemic or local infection at\u002Fnear the planned access route.\n\nDiffuse marrow replacement or extensive cortical destruction where percutaneous implantation is unsafe or unlikely to achieve local control without stabilization, per MDT judgment.\n\nPrior radiation or surgery to the index lesion that, in the investigator's opinion, makes additional seed implantation unsafe or non-beneficial; postoperative bed without a discrete target for seed placement.\n\nKnown hypersensitivity to materials\u002Fagents required for the procedure (e.g., contrast) not amenable to premedication or alternative imaging.\n\nUncontrolled medical conditions posing prohibitive procedural risk (e.g., severe cardiopulmonary disease, uncontrolled hypertension\u002Farrhythmia).\n\nPregnant or breastfeeding.\n\nInability to lie still or contraindications to required imaging\u002Fsedation not correctable.\n\nConcurrent participation in another interventional study that could confound efficacy\u002Fsafety assessment at the treated site.\n\nAny condition that, in the investigator's judgment, would interfere with protocol adherence, safety monitoring, or outcome assessment.","55 Years",{"count":19,"type":20},[103],"This prospective, open-label randomized trial evaluates a dual-simulation planning strategy that combines standard brachytherapy TPS with patient-specific biomechanical modeling for radioactive seed implantation in bone metastases. The approach aims to improve dose coverage while accounting for fracture risk, needle path stability, and seed migration. Eligible patients with painful and\u002For progressive bone metastases are randomized to dual-simulation planning versus conventional TPS. All undergo image-guided implantation with post-implant dosimetric verification and standardized follow-up. The primary endpoint is 3-month pain response (BPI\u002FVAS, adjusted for analgesic use). Secondary endpoints include dosimetry (D90, V100, CI, HI), local control\u002Fprogression, seed migration, skeletal-related events and fractures, SINS and functional status, quality of life, procedure-related complications (CTCAE v5.0), and procedure metrics. We hypothesize the dual-simulation strategy will enhance dosimetric quality and reduce biomechanics-related complications, improving pain and function.",[170],"Bone Metastases in Subjects With Advanced Cancer",[172,173,174],"tps","dynamics","osseous metastasis","RECRUITING","2025-09-11",{"date":178,"type":36},"2025-09-15",{"date":180,"type":36},"2025-07-01",{"date":182,"type":20},"2027-06-01",{"name":42,"class":43},""]