[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pathological-complete-response\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pathological-complete-response":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,71,101,125],{"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":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100639879","ultrasound-monitoring-of-clipped-lymph-nodes-to-predict-axillary-response-after-chemotherapy-in-breast-cancer-100639879",false,"NCT07596472","Ultrasound Monitoring of Clipped Lymph Nodes to Predict Axillary Response After Chemotherapy in Breast Cancer","A Prospective Diagnostic Clinical Study Based on Longitudinal Multimodal Ultrasound Evaluation of Clipped Lymph Nodes to Assess Axillary Pathological Response After Neoadjuvant Chemotherapy in Breast Cancer","Inclusion Criteria:\n\n* Female patients aged 18 years or older.\n\nClinical stage of breast cancer: T1-T4, N1-N3, M0.\n\nAxillary lymph node metastasis confirmed by fine-needle aspiration (FNA) or core-needle biopsy.\n\nIndicated for and planned to receive standard neoadjuvant chemotherapy (NAC) regimen.\n\nThe biopsy-proven metastatic lymph node is clearly visible on ultrasound and suitable for clip placement.\n\nCompletion of NAC followed by breast surgery and axillary lymph node dissection, with complete pathological results available.\n\nUnderwent multimodal ultrasound monitoring during NAC, including conventional ultrasound, elastography, and contrast-enhanced ultrasound.\n\nSigned informed consent and willingness to complete all scheduled follow-ups.\n\nExclusion Criteria:\n\n* Bilateral breast cancer.\n\nPatients who are not suitable for neoadjuvant chemotherapy or plan to receive endocrine or targeted therapy only.\n\nPrior breast or axillary surgery, chemotherapy, or other treatments that may affect the current therapeutic assessment.\n\nPresence of distant metastasis or extensive axillary invasion making clip placement or evaluation difficult.\n\nPregnant or lactating women.\n\nPoor image quality on ultrasound or other imaging modalities.\n\nInability to provide informed consent due to psychological, family, or social factors","FEMALE","18 Years",{"count":19,"type":20},150,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate whether longitudinal multimodal ultrasound can accurately predict axillary pathological response in breast cancer patients who receive neoadjuvant chemotherapy. In this study, patients with biopsy-proven metastatic axillary lymph nodes will have a metallic clip placed in the positive node before chemotherapy. During and after treatment, the clipped lymph node will be monitored by ultrasound, including gray-scale imaging, shear wave elastography, and contrast-enhanced ultrasound. The changes in the morphological and functional features of the clipped node will be analyzed to establish a predictive model for axillary pathological complete response. The results are expected to help identify patients who may safely avoid unnecessary axillary lymph node dissection and improve individualized surgical decision-making.",[24,25,26,27],"Breast Cancer","Axillary Lymph Node Metastasis","Neoadjuvant Chemotherapy","Pathological Complete Response","NOT_YET_RECRUITING","2026-05-13",{"date":31,"type":32},"2026-05-19","ACTUAL",{"date":34,"type":20},"2026-05-20",{"date":36,"type":20},"2027-05-20",{"name":38,"class":39},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100631396","tissue--and-serum-derived-exosomal-micrornas-as-predictors-of-neoadjuvant-chemotherapy-response-in-breast-cancer-100631396","NCT07500129","Tissue- and Serum-Derived Exosomal microRNAs as Predictors of Neoadjuvant Chemotherapy Response in Breast Cancer","Clinical and Mechanistic Validation of a Tumor-Derived Extracellular Vesicle-Associated miRNA Signature Predicting Response to Neoadjuvant Chemotherapy in Breast Cancer","ExoTSS-BC","Inclusion Criteria:\n\n* Female patients aged 18 years or older\n* Histologically confirmed locally advanced breast cancer scheduled to receive neoadjuvant chemotherapy\n* Availability of residual tumor tissue and\u002For serum samples obtained during routine clinical care\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Male sex\n* Age under 18 years\n* Prior systemic chemotherapy or radiotherapy administered for the current breast disease before enrollment.\n* Evidence of metastatic disease at diagnosis (for breast cancer cohort)\n* Pregnancy or breastfeeding\n* Any condition that precludes the availability or adequate quality of tissue or blood samples for research purposes",true,{"count":51,"type":20},60,"This prospective observational study aims to evaluate whether exosomal microRNA profiles derived from tumor tissue and blood serum are associated with pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in patients with breast cancer.\n\nBreast cancer patients with similar clinical and pathological features may respond differently to treatment, underscoring the need for reliable biomarkers that can help predict therapeutic outcomes. Exosomes are small extracellular vesicles released by tumor cells that carry molecular signals, including microRNAs, which may reflect tumor behavior and treatment sensitivity.\n\nIn this study, patients with breast cancer receiving standard NAC as part of routine clinical care will be followed prospectively. Exosomal microRNA profiles obtained from tumor tissue and blood samples collected during routine diagnostic and treatment procedures will be analyzed and compared with pathological complete response (pCR) assessed after completion of neoadjuvant chemotherapy.\n\nA group of patients with benign breast disease will be included as a reference control for comparative analyses.\n\nThe results of this study may contribute to the identification of minimally invasive biomarkers that support personalized treatment strategies in breast cancer.",[24,54,55,56,27],"Invasive Breast Carcinoma","Exosomal microRNA","Neoadjuvant Chemotherapy Response",[24,58,55,59,60,61,27],"Breast Cancer Biomarkers","Circulating microRNA","Tissue-derived exosomes","Serum-derived exosomes","2026-03-24",{"date":64,"type":32},"2026-03-30",{"date":66,"type":20},"2026-04-12",{"date":68,"type":20},"2027-04-22",{"name":70,"class":39},"Atlas University",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":79,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":40},"100574828","phase-2-neoadjuvant-immunochemotherapy-and-chemoradiotherapy-followed-by-surgery-for-advanced-esophageal-squamous-cell-carcinoma-100574828","NCT06764355","Neoadjuvant Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Advanced Esophageal Squamous Cell Carcinoma","Total Neoadjuvant Therapy With Induction Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma","NICE-ESCC","Inclusion Criteria:\n\n1. Pathologically proven squamous cell carcinoma of the intrathoracic esophagus.\n2. Locally advanced disease, which is defined by the TNM system of the American Joint Committee on Cancer (AJCC) Cancer Staging System (8th edition), fulfilling one of the following criteria as determined by staging procedures (including but not limited to endoscopic ultrasound, computed tomography, bronchoscopy or positron emission tomography):\n\n   1. cT3\u002F4a, N0, M0;\n   2. cT1-4a, N1-3, M0.\n3. Tumor length longitudinal ≤ 10cm and radial ≤ 5cm.\n4. The tumor must not extend more than 2cm into the stomach.\n5. No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula.\n6. Age ≥ 18 and ≤ 75 years old.\n7. Performance status ECOG 0\\~1.\n8. Adequate bone marrow reserves, defined as:\n\n   1. white blood cells (WBC) ≥ 3,000\u002Fµl or neutrophil count (ANC) ≥ 1,500\u002Fµl;\n   2. platelets ≥ 100,000\u002Fµl.\n9. Adequate liver function reserves, defined as:\n\n   1. hepatic transaminases ≤ 2.5 x upper limit of normal (ULN);\n   2. serum total bilirubin ≤ 2.0 x upper limit of normal (ULN).\n10. Adequate renal function: Creatinine ≤1.5 x upper normal limit or estimated creatinine clearance ≥ 50 ml\u002Fmin (estimated by Cockcroft-Gault formulation)\n11. Written informed consent.\n12. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be mandatory.\n13. Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section - Contraception, for the course of the study through 120 days after the last dose of study medication.\n\n    Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n14. Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in Section - Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n\nNote: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n\nExclusion Criteria:\n\n1. Adenocarcinoma\n2. Previous thoracic irradiation\n3. Previous systemic chemotherapy\n4. Has received prior therapy with an anti-PD-1 or anti-PD-L1\n5. Synchronous diagnosis of squamous cell carcinoma in the aerodigestive tract, other than esophageal cancer.\n6. Prior malignancy, except for the following:\n\n   1. adequately treated basal cell or squamous cell skin cancer;\n   2. in-situ cervical cancer;\n   3. a \"cured\" malignancy more than 5 years prior to enrollment.\n7. Significant co-morbid disease, which prohibits the conduction of immunochemotherapy, concurrent CRT, or radical surgery, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders.\n8. Documented myocardial infarction within the 6 months preceding registration (pretreatment ECG evidence of infarct only will not exclude patients). Patients with a history of significant ventricular arrhythmia requiring medication. Patients with a history of 2nd or 3rd degree heart block.\n9. Pre-existing motor or sensory neurotoxicity greater than grade 1.\n10. Patients with prior allergic reactions to drug containing Cremophor, such as teniposide or cyclosporine.\n11. Weight loss \\> 15%.\n12. Dementia or altered mental status that would prohibit the understanding and completion of informed consent.\n13. Estimated life expectancy less than 3 months.\n14. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n15. Has a known history of active TB (Bacillus Tuberculosis)\n16. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n17. Has known history of, or any evidence of active, non-infectious pneumonitis, interstitial lung disease or pulmonary fibrosis.\n18. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n19. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies).\n20. Patients with untreated chronic HBV or chronic HBV carriers whose HBV DNA is ≥500 IU\u002FmL, or patients with active HCV. Patients who are inactive carriers or with treated and stable hepatitis B (detectable B surface antigen and HBV DNA \\\u003C500 IU\u002FmL); patients with non-reactive HCV can be enrolled. Patients with chronic HBV infection need to be treated with anti-HBV agents while receiving immunochemotherapy and chemoradiotherapy according to the local and institutional guidelines.\n21. Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines are live attenuated vaccines, and are not allowed.\n22. Has received organ transplantation.\n23. Has declined esophagectomy.","ALL","75 Years",{"count":82,"type":20},50,"INTERVENTIONAL",[85],"PHASE2","Effective systemic therapy such as nivolumab as an adjuvant therapy has been demonstrated to improve the outcomes of patients receiving neoadjuvant chemoradiotherapy (CRT) for locoregional esophageal cancer. A more effective systemic therapy with anti-PD-1 or anti-PD-L1 immune checkpoint inhibitors (ICIs) plus cisplatin-based doublet chemotherapy, which has shown with high tumor response rate and improved survivals in patients with late-stage ESCC, may provide crucial benefit to patients with locally advanced disease by improving the systemic control, downstaging the locoregional tumor burden and reducing recurrence and metastasis.\n\nCollectively, the investigators hypothesize that total neoadjuvant therapy (TNT) approach-consisting of induction immunochemotherapy followed by CRT-is a promising strategy to enhance the outcomes for participants with locally advanced esophageal squamous cell carcinoma.",[88,89,27],"ESCC","Total Neoadjuvant Treatment",[88],"RECRUITING","2026-01-25",{"date":94,"type":32},"2026-01-27",{"date":96,"type":32},"2025-07-23",{"date":98,"type":20},"2028-12",{"name":100,"class":39},"National Taiwan University Hospital",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":79,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":40},"100599735","deep-learning-model-predicts-pathological-complete-response-of-esophageal-squamous-cell-carcinoma-following-neoadjuvant-immunochemotherapy-100599735","NCT07088354","Deep Learning Model Predicts Pathological Complete Response of Esophageal Squamous Cell Carcinoma Following Neoadjuvant Immunochemotherapy","DL-ESCC","Inclusion Criteria:\n\n1. Pathologically confirmed esophageal squamous cell carcinoma (ESCC).\n2. Received at least one cycle of neoadjuvant chemotherapy combined with immunotherapy.\n3. Underwent contrast-enhanced chest CT before initiation of neoadjuvant treatment.\n4. Underwent contrast-enhanced chest CT after completion of neoadjuvant treatment and prior to surgery.\n\nExclusion Criteria:\n\n1. Diagnosis of other malignancies.\n2. Received other anti-tumor therapies before or during neoadjuvant chemo-immunotherapy.\n3. Incomplete clinical data.\n4. Poor-quality CT imaging.",{"count":109,"type":20},300,"This study aims to develop and validate a deep learning model to predict pathological complete response (pCR) in patients with esophageal squamous cell carcinoma who have undergone neoadjuvant immunochemotherapy. Clinical, imaging, and pathological data from previously treated patients will be collected and analyzed. The model is expected to assist in predicting treatment outcomes and guide personalized therapeutic strategies.",[112,113,27,114],"Esophageal Squamous Cell Carcinoma","Neoadjuvant Immunochemotherapy","Deep Learning",[112,113,114,27],"2025-07-24",{"date":118,"type":32},"2025-07-28",{"date":120,"type":32},"2025-03-01",{"date":122,"type":20},"2026-12-01",{"name":124,"class":39},"Tongji Hospital",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":83,"phases":135,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":40},"100511468","omission-of-alnd-in-breast-cancer-patients-with-axillary-pcr-100511468","NCT05939830","Omission of ALND in Breast Cancer Patients With Axillary pCR","Omission of Axillary Lymph Node Dissection in Breast Cancer Patients With Axillary Pathological Complete Response After Neoadjuvant Systemic Therapy","Inclusion Criteria:\n\n1. Female aged between 18 and 70 years;\n2. Pathologically confirmed invasive breast cancer (regardless of pathological type) with a clinical stage cT1-3;\n3. Pathologically confirmed positive axillary lymph nodes with a clinical stage of N1-3;\n4. Receiving a full course of neoadjuvant therapy (including neoadjuvant chemotherapy, neoadjuvant targeted therapy, neoadjuvant immunotherapy);\n5. Positive axillary lymph nodes successfully stained by carbon nanoparticles injection;\n6. All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki- 67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases;\n7. Preoperative clinical assessment (including physical examination, imaging, with or without nomogram assessment) suggests positive axillary lymph nodes converted to negative (ycN0);\n8. ECOG score 0 - 1;\n9. Patients voluntarily participated in this study and signed the informed consent form\n\nExclusion Criteria:\n\n1. Bilateral breast cancer;\n2. Breast cancer during lactation period or pregnancy;\n3. Physical examination or imaging examination confirmed presence of distant metastases;\n4. Previous history of malignant tumor;\n5. History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;\n6. History of radiation therapy to the breast or chest;\n7. Positive incision margins for breast-conserving surgery\u002Fmastectomy;\n8. Positive results of intraoperative rapid freeze pathology (including isolated tumor cells and micrometastases) for SrLNB (ypN+);\n9. Those who unable to complete the full course of follow-up adjuvant therapy as prescribed for various reasons;\n10. Aspartate transaminase (AST) and alanine transaminase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase（ALP） ≥ 2.5 times the upper limit of normal, total bile ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; Left Ventricular Ejection Fractions (LVEF) \\\u003C 50% in cardiac ultrasound;\n11. Severe coagulation dysfunction, serious systemic disease, or uncontrolled infection;\n12. Without personal freedom and independent civil capacity;\n13. Those with mental disorders, addictions, who were not eligible for enrollment in the judgment of the investigator.","70 Years",{"count":134,"type":20},92,[136],"NA","This prospective, single-arm, phase II trial studies axillary lymph node dissection (ALND) to see if it can be safely omitted in breast cancer patients with axillary pathological complete response (pCR) after neoadjuvant systemic therapy (NST). Breast cancer patients with biopsy-proven positive axillary lymph nodes at initial diagnosis, and converted to negative after NST, which is confirmed by Stained region Lymph Node Biopsy(SrLNB), will be enrolled in the study. In other words, a total of 92 patients will be exempted from ALND after SrLNB, and afterwards complete regional node irradiation (RNI) including the axilla. They will also undergo adjuvant chemotherapy, targeted therapy, endocrinotherapy after surgery. These patients will be followed up in the next three years for local-regional recurrence and long-time survival outcome.",[139,27,140,24,141],"Axillary Lymph Node Dissection","Neoadjuvant Systemic Therapy","Axillary Lymph",[24,140,143],"Axillary Surgery","2024-12-27",{"date":146,"type":32},"2024-12-30",{"date":148,"type":32},"2023-09-11",{"date":150,"type":20},"2026-07",{"name":152,"class":39},"The First Affiliated Hospital with Nanjing Medical University"]