[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658739":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":71,"studyPopulation":71,"armGroups":75,"interventions":84,"overallOfficials":71,"centralContacts":101,"locations":107,"responsibleParty":230,"collaborators":71,"id":234,"slug":235,"hasResults":236,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":236,"sex":242,"minAge":243,"maxAge":244,"enrollmentInfo":245,"targetDuration":71,"studyType":248,"phases":249,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":140,"whyStopped":71,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":268},{"fullName":5,"class":6},"West China Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Pathological Complete Response (pCR) Rate","The proportion of enrolled participants who achieve pathological complete response (pCR), defined as no residual viable tumor cells in the resected primary tumor and all sampled regional lymph nodes after neoadjuvant treatment (ypT0N0).\n\nParticipants who do not undergo surgical resection or for whom pathological response cannot be adequately assessed will not be considered to have achieved pCR in the primary efficacy analysis.","At pathological evaluation of the surgical resection specimen, with surgery planned approximately 4-6 weeks after the final neoadjuvant treatment.",[14,18,21,25,29,33,37],{"measure":15,"description":16,"timeFrame":17},"Objective Response Rate (ORR)","The proportion of enrolled participants who achieve a complete response (CR) or partial response (PR) as their radiographic tumor response before surgery, as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.","At preoperative radiographic reassessment, approximately 4-6 weeks after the final neoadjuvant treatment.",{"measure":19,"description":20,"timeFrame":12},"Major Pathological Response (MPR) Rate","The proportion of enrolled participants who achieve major pathological response (MPR), defined as ≤10% residual viable tumor cells within the primary tumor bed in the resected lung specimen after neoadjuvant treatment, based on pathological assessment according to IASLC recommendations.\n\nPathological response in regional lymph nodes will be assessed and reported separately and will not be included in the primary definition of MPR.",{"measure":22,"description":23,"timeFrame":24},"R0 resection rate","The proportion of participants undergoing surgical resection who achieve an R0 resection, defined as complete macroscopic resection of the tumor with microscopically negative surgical margins and no residual tumor at the resection margins.","At surgical and pathological evaluation of the resection specimen, with surgery planned approximately 4-6 weeks after the final neoadjuvant treatment.",{"measure":26,"description":27,"timeFrame":28},"Event-Free Survival (EFS)","Event-free survival (EFS) is defined as the time from enrollment to the first occurrence of any of the following events: radiographic disease progression; local disease progression resulting in unresectability; inability to undergo the planned curative-intent surgery because of treatment-related toxicity or deterioration in clinical condition attributable to study treatment; failure to achieve tumor resection because of intraoperative unresectability; local or distant disease recurrence after surgery; or death from any cause. Participants without an EFS event will be censored at the date of the last disease assessment.","From enrollment until the first EFS event, death, last disease assessment, or end of follow-up, up to approximately 5 years.",{"measure":30,"description":31,"timeFrame":32},"Overall Survival (OS)","Overall survival (OS) is defined as the time from enrollment to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive.","From enrollment until death from any cause or the end of follow-up, up to approximately 5 years.",{"measure":34,"description":35,"timeFrame":36},"Change From Baseline in EORTC QLQ-C30 Global Health Status\u002FQuality of Life Score","Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The Global Health Status\u002FQuality of Life scale is transformed to a score ranging from 0 to 100, with higher scores indicating better overall health status and quality of life. Changes from baseline will be evaluated across predefined perioperative assessment time points.","Baseline before Cryo-Thermal Ablation; preoperative assessment approximately 4-6 weeks after the final neoadjuvant treatment; and approximately 30 days after surgical resection.",{"measure":38,"description":39,"timeFrame":40},"Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)","The proportion of participants who experience one or more treatment-emergent adverse events (TEAEs). Adverse events will be assessed for type, severity, and relationship to study treatment and graded according to NCI-CTCAE version 5.0. Safety assessments will include events associated with Cryo-Thermal Ablation, neoadjuvant chemoimmunotherapy, and the perioperative treatment course.","From Cryo-Thermal Ablation through 30 days after surgical resection; for participants not undergoing surgery, through 30 days after discontinuation of protocol-defined treatment.",[42,46,50,54,58,62,65],{"measure":43,"description":44,"timeFrame":45},"Changes in the Spatial Tumor Immune Microenvironment Assessed by Atera In Situ Spatial Transcriptomics","Atera In Situ single-cell spatial transcriptomic profiling will be performed on FFPE tumor specimens. Within-participant changes from the baseline tumor biopsy before Cryo-Thermal Ablation to the surgical tumor specimen after neoadjuvant chemoimmunotherapy will be evaluated. Spatial immune features in the surgical specimen will also be compared among residual tumor, adjacent tissue, and normal lung tissue when available. Analyses will characterize spatial distributions and transcriptional states of CD8+ T cells, regulatory T cells, myeloid populations, interferon-related signaling, antigen-presentation pathways, and T-cell activation\u002Fexhaustion programs. Features will also be compared between participants with and without MPR; pCR will be explored as a subgroup.","Baseline tumor biopsy before Cryo-Thermal Ablation and surgical resection approximately 4-6 weeks after the final neoadjuvant treatment.",{"measure":47,"description":48,"timeFrame":49},"Changes in Peripheral and Tumor T-cell Receptor Clonality Assessed by Bulk TCR Sequencing","Bulk T-cell receptor sequencing (TCR-seq) will be performed on peripheral blood mononuclear cells and tumor tissue to characterize treatment-associated T-cell clonal dynamics. Peripheral blood will be collected at baseline before Cryo-Thermal Ablation, approximately 14 days after ablation before Cycle 1, before Cycles 2 and 3 of neoadjuvant chemoimmunotherapy, and after completion of neoadjuvant therapy before surgery. TCR repertoire diversity, clonality, and clonal expansion will be evaluated longitudinally. Tumor tissue from the baseline biopsy and surgical resection specimen will also undergo TCR-seq. Changes in intratumoral T-cell clonality and overlap between blood and tumor TCR clonotypes will be explored in relation to pathological response and treatment-related toxicity.","Peripheral blood: baseline; Day 14 after ablation before Cycle 1; before Cycle 2 (approximately Day 35) and Cycle 3 (approximately Day 56); and preoperative assessment 4-6 weeks after Cycle 3. Tumor tissue: baseline biopsy and surgical resection.",{"measure":51,"description":52,"timeFrame":53},"Tumor Genomic Alterations Assessed by a 919-Gene Next-Generation Sequencing Panel","Baseline FFPE tumor biopsy specimens will undergo next-generation sequencing using a 919-gene cancer-associated panel. Somatic genomic alterations, including relevant mutations and other detectable genomic features, will be characterized. Exploratory analyses will evaluate associations between baseline tumor genomic characteristics and pathological response to Cryo-Thermal Ablation combined with neoadjuvant chemoimmunotherapy.","Baseline tumor biopsy before Cryo-Thermal Ablation.",{"measure":55,"description":56,"timeFrame":57},"Longitudinal Changes in Circulating Tumor DNA and Molecular Residual Disease","Circulating tumor DNA (ctDNA) will be longitudinally assessed to characterize changes in tumor-derived molecular signals during treatment and postoperative surveillance. During neoadjuvant treatment, ctDNA levels and detectable tumor-associated alterations will be evaluated at baseline before ablation, 14 days after ablation, and at the preoperative assessment after completion of neoadjuvant therapy. ctDNA clearance and changes in variant allele abundance will be explored according to pathological response. Serial postoperative ctDNA testing will be used to assess molecular residual disease (MRD) and its relationship with subsequent disease recurrence. Longitudinal ctDNA profiles will also be explored for changes in detectable tumor clones over time.","Baseline before ablation; Day 14 after ablation; at the preoperative assessment approximately 4-6 weeks after the final neoadjuvant treatment; and Months 1, 4, 7, 10, 16, 22, 28, and 34 after surgery.",{"measure":59,"description":60,"timeFrame":61},"Spatial Immune Phenotypes Assessed by Imaging Mass Cytometry","Imaging Mass Cytometry (IMC) will be performed on selected FFPE surgical tumor specimens after neoadjuvant treatment as an orthogonal protein-level validation of spatial immune findings. Analyses will quantify selected immune cell populations and protein markers, including CD8+ T cells, regulatory T cells, myeloid populations, PD-L1, antigen-presentation markers, and markers of immune activation or proliferation such as granzyme B (GZMB) and Ki-67. Spatial relationships between immune cells and tumor cells, including immune-cell density, cellular proximity, and tumor-immune spatial organization, will be compared between participants with MPR and those without MPR. pCR cases will be explored as a subgroup where evaluable tissue is available.","At surgical resection, approximately 4-6 weeks after the final neoadjuvant treatment.",{"measure":63,"description":64,"timeFrame":61},"Intratumoral Microbial Relative Abundance Assessed by Metagenomic Sequencing","Tumor or tumor-bed specimens obtained at surgical resection will undergo metagenomic sequencing to characterize the intratumoral microbiome. The relative abundance of detected microbial taxa will be quantified and reported as the percentage of the total microbial abundance represented by each taxon. Microbial relative abundance profiles will be compared between participants with major pathological response (MPR) and those without MPR. Pathological complete response (pCR) cases will be explored as a subgroup when tumor-bed specimens are technically evaluable.",{"measure":66,"description":67,"timeFrame":61},"Intratumoral Metabolite Abundance Assessed by Metabolomic Profiling","Tumor or tumor-bed specimens obtained at surgical resection will undergo metabolomic profiling to characterize intratumoral metabolic features. Detected metabolites will be quantified using normalized metabolite abundance, expressed as normalized signal intensity in arbitrary units. Metabolite abundance profiles will be compared between participants with major pathological response (MPR) and those without MPR. Pathological complete response (pCR) cases will be explored as a subgroup when tumor-bed specimens are technically evaluable.",{"allocation":69,"interventionModel":70,"interventionModelDescription":71,"primaryPurpose":72,"observationalModel":71,"timePerspective":71,"maskingInfo":73},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":74,"maskingDescription":71,"whoMasked":71},"NONE",[76],{"label":77,"type":78,"description":79,"interventionNames":80},"Neoadjuvant Cryo-Thermal Ablation Combined With Toripalimab and Platinum-Based Doublet Chemotherapy","EXPERIMENTAL","Participants will receive CT-guided Cryo-Thermal Ablation followed by 3 planned cycles of toripalimab plus histology-appropriate platinum-based doublet chemotherapy administered every 3 weeks, followed by curative-intent surgical resection after preoperative reassessment.",[81,82,83],"Procedure: Cryo-Thermal Ablation","Drug: Toripalimab","Drug: Platinum-based doublet chemotherapy",[85,92,97],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":90},"PROCEDURE","Cryo-Thermal Ablation","Cryo-Thermal Ablation is a CT-guided percutaneous local ablation procedure performed on the primary lung tumor before initiation of neoadjuvant systemic therapy. Under CT guidance, one or more ablation probes are placed percutaneously into the target lesion. Sequential cryogenic and thermal treatment is delivered according to the study protocol and device operating instructions. Technical parameters, including probe placement, treatment cycles, treatment duration, and target temperatures, will be standardized according to the protocol.",[77],[91],"Ablation",{"type":93,"name":94,"description":95,"armGroupLabels":96,"otherNames":71},"DRUG","Toripalimab","Toripalimab, an anti-programmed cell death protein 1 (PD-1) monoclonal antibody, will be administered intravenously at a dose of 240 mg every 3 weeks (q3w) in combination with platinum-based doublet chemotherapy for 3 planned cycles following Cryo-Thermal Ablation. Dose interruption, delay, or discontinuation will be permitted when clinically indicated for treatment-related toxicity.",[77],{"type":93,"name":98,"description":99,"armGroupLabels":100,"otherNames":71},"Platinum-based doublet chemotherapy","Participants will receive protocol-specified platinum-based doublet chemotherapy in combination with toripalimab every 3 weeks for 3 planned cycles following Cryo-Thermal Ablation. The specific regimen will be selected according to tumor histology and the study protocol. Chemotherapy dosing, administration, dose modification, and supportive treatment will follow the protocol-defined regimen and standard clinical practice. After neoadjuvant therapy, disease reassessment will be performed before curative-intent surgical resection.",[77],[102],{"name":103,"role":104,"phone":105,"phoneExt":71,"email":106},"Beinuo Wang, MD","CONTACT","+86-191-0807-4950","wang_beinuo@163.com",[108,127,138,149,160,174,188,202,216],{"facility":109,"status":110,"city":111,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"The Third People's Hospital of Chengdu","NOT_YET_RECRUITING","Chengdu","Sichuan","610031","China","CN",{"type":117,"coordinates":118},"Point",[119,120],104.06667,30.66667,{"lat":120,"lon":119},[123],{"name":124,"role":104,"phone":125,"phoneExt":71,"email":126},"Yi Yang","+86 28 61312288","191888@qq.com",{"facility":128,"status":110,"city":111,"state":112,"zip":129,"country":114,"countryCode":115,"cosmosGeoPoint":130,"geoPoint":132,"contacts":133},"Sichuan Cancer Hospital & Institute","610041",{"type":117,"coordinates":131},[119,120],{"lat":120,"lon":119},[134],{"name":135,"role":104,"phone":136,"phoneExt":71,"email":137},"Xuefeng Leng","+86 28 85420305","leng724@163.com",{"facility":139,"status":140,"city":111,"state":112,"zip":129,"country":114,"countryCode":115,"cosmosGeoPoint":141,"geoPoint":143,"contacts":144},"West China Hospital, Sichuan University","RECRUITING",{"type":117,"coordinates":142},[119,120],{"lat":120,"lon":119},[145],{"name":146,"role":104,"phone":147,"phoneExt":71,"email":148},"Hu Liao, MD","19108074950","drliaohu@scu.edu.cn",{"facility":150,"status":110,"city":111,"state":112,"zip":151,"country":114,"countryCode":115,"cosmosGeoPoint":152,"geoPoint":154,"contacts":155},"Public Health Clinical Center of Chengdu","610066",{"type":117,"coordinates":153},[119,120],{"lat":120,"lon":119},[156],{"name":157,"role":104,"phone":158,"phoneExt":71,"email":159},"Xiaojun Yao","+86 28 65233185","flyingyao@163.com",{"facility":161,"status":110,"city":162,"state":112,"zip":163,"country":114,"countryCode":115,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"The Affiliated Hospital of Southwest Medical University","Luzhou","646000",{"type":117,"coordinates":165},[166,167],105.42575,28.8903,{"lat":167,"lon":166},[170],{"name":171,"role":104,"phone":172,"phoneExt":71,"email":173},"Jiangtao Pu","18980605130","pjtapollo@sohu.com",{"facility":175,"status":110,"city":176,"state":112,"zip":177,"country":114,"countryCode":115,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Meishan People's Hospital","Meishan","620010",{"type":117,"coordinates":179},[180,181],103.83696,30.04392,{"lat":181,"lon":180},[184],{"name":185,"role":104,"phone":186,"phoneExt":71,"email":187},"Qiwei Kan","+86 28 38509261","646967480@qq.com",{"facility":189,"status":110,"city":190,"state":112,"zip":191,"country":114,"countryCode":115,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Affiliated Hospital of North Sichuan Medical College","Nanchong","637000",{"type":117,"coordinates":193},[194,195],106.08473,30.79508,{"lat":195,"lon":194},[198],{"name":199,"role":104,"phone":200,"phoneExt":71,"email":201},"Maoyong Fu","+86 817 2262120","fumaoyongmd@163.com",{"facility":203,"status":110,"city":204,"state":112,"zip":205,"country":114,"countryCode":115,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Suining Central Hospital","Suining","629000",{"type":117,"coordinates":207},[208,209],105.57332,30.50802,{"lat":209,"lon":208},[212],{"name":213,"role":104,"phone":214,"phoneExt":71,"email":215},"Haining Zhou","+86 825 2291234","haining_zhou@zmu.edu.cn",{"facility":217,"status":110,"city":218,"state":112,"zip":219,"country":114,"countryCode":115,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Zigong Fourth People's Hospital","Zigong","643000",{"type":117,"coordinates":221},[222,223],104.77689,29.34162,{"lat":223,"lon":222},[226],{"name":227,"role":104,"phone":228,"phoneExt":71,"email":229},"Yun Huang","+86 813 2102560","zgsdsrmyygcp@163.com",{"type":231,"investigatorFullName":232,"investigatorTitle":233,"investigatorAffiliation":5,"oldNameTitle":71,"oldOrganization":71},"PRINCIPAL_INVESTIGATOR","Hu Liao","Deputy Director & Medical Team Leader, Department of Thoracic Surgery, West China Hospital, Sichuan University; Associate Professor of Surgery; Master's Supervisor","100658739","phase-2-multicenter-single-arm-prospective-phase-ii-study-of-neoadjuvant-cryo-thermal-ablation-combined-with-toripalimab-and-chemotherapy-for-resectable-stage-ib-iiib-non-small-cell-lung-cancer-100658739",false,"NCT07855965","Multicenter, Single-Arm, Prospective Phase II Study of Neoadjuvant Cryo-Thermal Ablation Combined With Toripalimab and Chemotherapy for Resectable Stage IB-IIIB Non-Small Cell Lung Cancer","Efficacy and Safety of Cryo-Thermal Ablation Combined With Toripalimab and Chemotherapy as Neoadjuvant Treatment for Resectable Stage IB-IIIB Non-Small Cell Lung Cancer: A Multicenter, Single-Arm, Prospective Phase II Clinical Trial","NEOCTATC","Inclusion Criteria\n\n1. Diagnosis, Stage, and Resectability\n\n   * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).\n   * Clinical stage IB-IIIB according to the 9th edition IASLC\u002FAJCC TNM classification.\n   * For stage IB disease, only patients with a maximum tumor diameter of 4.0 cm (cT2aN0M0) are eligible.\n   * The disease must be considered resectable by multidisciplinary team (MDT) assessment with curative-intent surgery planned after neoadjuvant treatment.\n   * The primary lung lesion must be technically amenable to percutaneous biopsy and CT-guided Cryo-Thermal Ablation..\n   * No prior systemic or local anti-tumor therapy for the current NSCLC.\n2. Age, Performance Status, and General Condition\n\n   * Age 18-80 years.\n   * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n   * Estimated life expectancy \\>6 months.\n   * Able to understand and voluntarily sign the informed consent form and willing to comply with study treatment, specimen collection, and follow-up requirements.\n3. Tumor Tissue and Pulmonary Function\n\n   * Willing to provide tumor tissue and blood samples required by the study protocol.\n   * Adequate pulmonary function for the planned treatment and subsequent pulmonary resection, including: FEV1 ≥1.2 L or ≥50% of predicted value; and predicted postoperative FEV1≥30% of predicted value.\n4. Adequate Organ Function\n\n   Laboratory assessments performed within 7 days before the first study intervention must meet the following criteria:\n   * Hemoglobin ≥9.0 g\u002FdL;\n   * absolute neutrophil count ≥1.0 × 10⁹\u002FL;\n   * platelet count ≥90 × 10⁹\u002FL;\n   * total bilirubin ≤2.0 × upper limit of normal (ULN);\n   * alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤2.5 × ULN;\n   * serum creatinine ≤2.0 mg\u002FdL and creatinine clearance ≥60 mL\u002Fmin;\n   * adequate thyroid function. If thyroid-stimulating hormone (TSH) is outside the normal range, free T3 and free T4 must be within clinically acceptable limits; no clinically significant abnormality in cardiac enzyme testing;\n   * international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5 × ULN, unless abnormalities are attributable to protocol-permitted anticoagulation.\n5. Reproductive Requirements\n\n   * Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (HCG) pregnancy test within 7 days before initiation of study treatment.\n   * Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception from enrollment until at least 180 days after the last dose of study systemic therapy.\n\nExclusion Criteria\n\n1. Histological or Molecular Characteristics\n\n   * Small-cell lung cancer (SCLC) or mixed histology containing a small-cell component.\n   * Presence of protocol-defined actionable oncogenic alterations detected by tumor tissue and\u002For plasma-based molecular testing, including:\n   * EGFR sensitizing or protocol-defined activating alterations, including exon 19 deletion, L858R, G719X, S768I, L861Q, or exon 20 insertion;\n   * ALK rearrangement;\n   * ROS1 rearrangement;\n   * MET exon 14 skipping alteration or protocol-defined MET amplification;\n   * KRAS G12C;\n   * BRAF V600E;\n   * NTRK1\u002F2\u002F3 fusion;\n   * RET rearrangement; or HER2 alteration as defined in the study protocol.\n2. Contraindications to Percutaneous Biopsy or Cryo-Thermal Ablation\n\n   * Active clinically significant hemoptysis, defined as ≥1\u002F2 teaspoon of fresh blood, within 2 weeks before the planned procedure.\n   * Clinically significant bleeding tendency or coagulation disorder that cannot be adequately corrected before biopsy or ablation.\n   * Therapeutic anticoagulant or vitamin K antagonist treatment that cannot be safely interrupted or managed during the periprocedural period according to the study protocol and institutional practice. Stable anticoagulation may be permitted when appropriate periprocedural interruption or management is considered safe by the investigator.\n   * Active infection involving the planned biopsy or ablation site or access pathway.\n   * Any anatomical or clinical condition considered by the investigator to make percutaneous biopsy or combined Cryo-Thermal Ablation unsafe.\n3. Clinically Significant Cardiovascular or Systemic Disease\n\n   * Uncontrolled hypertension.\n   * Unstable angina, myocardial infarction within 3 months before enrollment, New York Heart Association (NYHA) class II or higher heart failure considered clinically significant by the investigator, or severe\u002Funcontrolled arrhythmia.\n   * Severe or uncontrolled hepatic, renal, metabolic, or other systemic disease that could interfere with study treatment or assessment.\n4. Immunotherapy-Related Contraindications\n\n   * Active or suspected autoimmune disease requiring systemic treatment, except for conditions permitted by the protocol, such as vitiligo, type 1 diabetes mellitus, or adequately controlled autoimmune hypothyroidism.\n   * History of autoimmune disease requiring systemic treatment with disease-modifying agents, corticosteroids, or immunosuppressive therapy within 2 years before enrollment, except as specifically permitted by the protocol.\n   * Requirement for chronic systemic immunosuppressive treatment.\n   * Systemic glucocorticoid treatment within 7 days before initiation of systemic study treatment, except physiologic replacement therapy equivalent to prednisone ≤10 mg\u002Fday.\n   * Uncontrolled peripheral neuropathy of grade ≥2 or other condition that, in the investigator's judgment, would substantially increase the risk of study treatment.\n   * Psychiatric, cognitive, or other conditions that would prevent adequate informed consent or compliance with study procedures.\n5. Active or Clinically Significant Infection\n\n   * Active tuberculosis or inadequately controlled tuberculosis treated within 1 year before enrollment.\n   * Human immunodeficiency virus (HIV) infection with clinically significant immunodeficiency or acquired immunodeficiency syndrome (AIDS), as defined by the study protocol.\n   * Active hepatitis B infection with HBV DNA above the protocol-defined acceptable limit.\n   * Active hepatitis C infection with detectable HCV RNA.\n   * Other uncontrolled active infection requiring systemic therapy that, in the investigator's judgment, would interfere with study treatment.\n6. Pulmonary Conditions\n\n   * Interstitial lung disease, interstitial pneumonia, pneumoconiosis, drug-induced pneumonitis, or other clinically significant diffuse pulmonary disease that may increase the risk of study treatment.\n   * Severe impairment of pulmonary function incompatible with the planned ablation, systemic therapy, or subsequent surgical resection.\n   * Clinically uncontrolled pleural or pericardial effusion. Participants whose effusion is adequately controlled and clinically stable after drainage may be eligible according to investigator assessment and the study protocol.\n7. Other Malignancies\n\n   * Another malignancy diagnosed within 2 years before enrollment, except malignancies with a negligible risk of metastasis or death that have been adequately treated, such as basal cell or squamous cell carcinoma of the skin or carcinoma in situ treated with curative intent.\n8. Concurrent or Recent Treatments\n\n   * Participation in another interventional clinical trial or receipt of another investigational drug or investigational device within 4 weeks before the first study intervention.\n   * Receipt of anti-cancer traditional Chinese patent medicines or systemic immunomodulatory agents, including thymosin, interferons, or interleukins, within 2 weeks before initiation of study treatment.\n   * Receipt of a live attenuated vaccine within 30 days before initiation of study treatment. Inactivated vaccines, including inactivated influenza vaccines, are permitted.\n9. Pregnancy, Lactation, and Transplantation\n\n   * Pregnancy or breastfeeding.\n   * Unwillingness to comply with protocol-specified contraceptive requirements.\n   * Previous organ or bone marrow transplantation, or planned transplantation during the study period.\n10. Other Exclusion Criteria\n\n    * Known severe hypersensitivity or contraindication to toripalimab, protocol-specified chemotherapy agents, their excipients, or materials used in the ablation procedure.\n    * Any other medical, psychological, social, or logistical condition that, in the investigator's judgment, makes the participant unsuitable for study enrollment or could interfere with treatment safety, protocol compliance, or interpretation of study results.","ALL","18 Years","80 Years",{"count":246,"type":247},40,"ESTIMATED","INTERVENTIONAL",[250],"PHASE2","Neoadjuvant chemoimmunotherapy has improved outcomes in patients with resectable non-small cell lung cancer (NSCLC), but a substantial proportion of patients do not achieve a major pathological response. Cryo-Thermal Ablation may induce immunogenic tumor cell death and remodel the tumor immune microenvironment, potentially enhancing the antitumor activity of subsequent chemoimmunotherapy.\n\nThis multicenter, single-arm, open-label, prospective Phase II study will evaluate the efficacy and safety of CT-guided Cryo-Thermal Ablation followed by toripalimab plus platinum-based doublet chemotherapy as neoadjuvant treatment for patients with resectable stage IB-IIIB NSCLC. For stage IB disease, only patients with cT2aN0M0 disease and a maximum primary tumor diameter of 4.0 cm are eligible. Patients with more advanced disease must be considered resectable by multidisciplinary team assessment according to the study protocol.\n\nApproximately 40 participants will receive Cryo-Thermal Ablation followed by 3 planned cycles of toripalimab plus platinum-based doublet chemotherapy and subsequent curative-intent surgical resection.\n\nThe primary outcome is the pathological complete response (pCR) rate. Secondary outcomes include major pathological response (MPR) rate, objective response rate (ORR), R0 resection rate, event-free survival (EFS), overall survival (OS), treatment-emergent adverse events (TEAEs), and health-related quality of life.\n\nExploratory translational analyses will investigate treatment-associated local and systemic antitumor immune responses and molecular dynamics using spatial transcriptomics, T-cell receptor sequencing, tumor genomic profiling, circulating tumor DNA analysis, imaging mass cytometry, and exploratory intratumoral metagenomic and metabolomic profiling.",[253],"Carcinoma, Non-Small-Cell Lung (NSCLC)",[255,256,91,94,257,258],"Neoadjuvant therapy","Resectable non-small cell lung cancer","PD-1 inhibitor","Chemoimmunotherapy","2026-09-28",{"date":261,"type":262},"2026-10-02","ACTUAL",{"date":264,"type":262},"2026-09-10",{"date":266,"type":247},"2033-08-05",{"name":5,"class":6},9]