[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoadjuvant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoadjuvant":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,51,78,105,136,164,186],{"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":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100584515","phase-2-a-study-to-assess-anti-tumor-activity-of-intravenously-iv-infused-carboplatin-with-mirvetuximab-soravtansine-in-participants-with-newly-diagnosed-folate-receptor-alpha-frexpressing-advanced-stage-serous-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-cancer-100584515",false,"NCT06890338","A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.","A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects With FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n* Be judged by the investigator and\u002For treating physician to be an appropriate candidate to receive neoadjuvant chemotherapy.\n* Diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer.\n* Participant meets the following disease criteria:\n\n  * Stage III or IV disease by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system, and\n  * Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of \\>= 75% of viable tumor cells with moderate \\>= 2+ membrane staining by the Ventana Folate Receptor Alpha (VENTANA FOLR1) assay, FOLR1 Eligibility Testing - Ventana FOLR1 (FOLR1-2.1) RxDx - Commercial or Central, and\n  * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria.\n\nExclusion Criteria:\n\n* Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade\u002Fborderline ovarian tumor.\n* Previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis.\n* Previously treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin\n* Participants with the following ocular history and\u002For concurrent disorders:\n\n  * History of corneal transplantation;\n  * Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery;\n  * Confluent superficial punctate keratopathy (SPK) not expected to resolve to non-confluence or better within the screening window with standard of care (SOC) intervention;\n  * Active or chronic clinically significant (\\>= Grade 3) corneal dystrophy (e.g., Fuchs dystrophy);\n  * Active ocular conditions requiring ongoing treatment\u002Fmonitoring, such as glaucoma, which is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema or an ocular condition with high risk of retinal detachment;\n  * Monocular vision with visual acuity in the worse eye, worse than 20\u002F200 or visual fields less than 20 degrees (i.e., functional blindness in at least one eye).\n* History of other malignancy within 3 years prior to signing study consent. -- Note: Participants with tumors with a negligible risk for metastasis or death (e.g., adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible.","FEMALE","18 Years",{"count":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC).\n\nMirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States.\n\nParticipants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years .\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.",[26,27,28,29],"Epithelial Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Cancer","Neoadjuvant",[26,27,28,29,31,32,33,34,35,36,37],"Interval Debulking Surgery","Mirvetuximab Soravtansine","MIRV","IMGN853","ELAHERE(R)","Carboplatin","Bevacizumab","RECRUITING","2026-06-15",{"date":41,"type":42},"2026-06-16","ACTUAL",{"date":44,"type":42},"2025-11-21",{"date":46,"type":20},"2030-02",{"name":48,"class":49},"AbbVie","INDUSTRY",66,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":17,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100496014","phase-3-neoadjuvant-of-axitinib-plus-pd-1-to-improve-disease-free-survival-of-patients-with-renal-cell-carcinoma-100496014","NCT05738694","Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma","A Multicenter Randomized Controlled Clinical Study of Neoadjuvant Combination of Axitinib Plus PD-1 Monoclonal Antibody to Improve Disease Free Survival of Patients With Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Voluntarily agree to participate in this study and sign the informed consent form;\n2. Males or females between 18 years old and 80 years old;\n3. Diagnosed as clear cell carcinoma or renal cell carcinoma predominantly composed of clear cell carcinoma through histopathological examination\n4. CT or MRI clinical staging is T2G4 or T2 with sarcomatoid differentiation, T3-4, N1;\n5. ECOG performance status: 0 or 1 point;\n6. Sufficient heart, bone marrow, liver, and kidney functions:\n\nCardiac function: Cardiac function class 0-2; Blood routine test: WBC≥3.5×10\\^9\u002FL, absolute neutrophil count ≥1.5×10\\^9\u002FL, PLT≥75.0×10\\^9\u002FL, HGB≥80g\u002FL; Liver function: Total bilirubin ≤1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; Renal function: GFR ≥ 45 ml\u002Fmin.\n\nExclusion Criteria:\n\n1. With distant metastasis\n2. Severe liver and renal dysfunction, combined with other serious diseases;\n3. Serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) in the past 1 year;\n4. Severe\u002Funstable angina pectoris; uncontrolled hypertension;\n5. Class III or IV heart failure by New York Heart Association (NYHA) Functional Classification;\n6. Ventricular arrhythmia requiring drug treatment.","ALL","80 Years",{"count":61,"type":20},298,[63],"PHASE3","The study included 298 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1). They were randomly divided to receive axitinib plus PD-1 + surgery or surgery alone at a ratio of 1:1, so as to determine the efficacy of the neoadjuvant combination of axitinib plus PD-1.",[66,29],"Renal Cell Carcinoma","2026-03-15",{"date":69,"type":42},"2026-03-17",{"date":71,"type":42},"2023-04-19",{"date":73,"type":20},"2027-12-31",{"name":75,"class":76},"ZHOU FANGJIAN","OTHER",8,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":58,"minAge":17,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100622544","phase-1-a-prospective-multicenter-phase-ibii-trial-of-ivonescimab-ak112-combined-with-albumin-paclitaxel-and-cisplatin-as-neoadjuvant-therapy-for-escc-100622544","NCT07385001","A Prospective, Multicenter, Phase Ib\u002FII Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC","Phase Ib\u002FII Trial of Atezolizumab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Informed Consent: Written informed consent must be obtained before any study-related procedures are initiated.\n* Age and Gender: Participants must be between 18 and 75 years of age, inclusive of both 18 and 75 years, and may be either male or female.\n* Diagnosis and Stage: Participants must be histologically confirmed to have resectable, locally advanced esophageal squamous cell carcinoma (ESCC) with the following criteria:-T1 N1-N3 M0 or T2-T4a N0-N3 M0 (with T2 ≥ 2 cm or poorly differentiated).\n* Lymph Node Status: No suspicious lymph nodes in the neck region (excluding lymph nodes in the upper thoracic esophageal area) as per neck ultrasound or enhanced CT scan; no evidence of systemic metastasis on imaging.\n* R0 Resectability: The participant is expected to achieve R0 resection.\n* Measurable Lesion: At least one measurable tumor lesion must be present.\n* Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Expected Survival: The participant is expected to have a survival duration of at least 3 months.\n* Thyroid Function: Normal thyroid function is defined as a thyroid-stimulating hormone (TSH) level within the normal range. Participants with baseline TSH levels outside the normal range may still be eligible if total T3 (or free T3) and free T4 levels are within the normal range.\n* Organ Function: Laboratory results must meet the following criteria:\n\nHematology (no blood transfusion or blood component or granulocyte colony-stimulating factor treatment within 14 days): Neutrophil count (NEU) ≥ 1.5 × 10⁹\u002FL (1,500\u002Fmm³); Platelet count (PLT) ≥ 100 × 10⁹\u002FL (100,000\u002Fmm³); Hemoglobin ≥ 90 g\u002FL.\n\nLiver: Total bilirubin (TBil) ≤ 1.5 × upper limit of normal (ULN); or for participants with TBil \\\u003C 1.5 × ULN, direct bilirubin must be within the normal range; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n\nRenal: Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (using the Cockcroft-Gault formula).\n\nCoagulation: International Normalized Ratio (INR) ≤ 1.5; Prothrombin time (PT) or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.\n\nCardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50%.\n\n* Pregnancy Testing and Contraception: For screening-period eligible female participants of reproductive age, a serum pregnancy test must be negative. Female or male participants of reproductive capacity must be willing to use a reliable contraceptive method throughout the study period (i.e., from the date of informed consent to 90 days after the last dose of study drug), including but not limited to: abstinence, vasectomy in the male partner, sterilization in the female, effective intrauterine devices, and effective oral contraceptives.\n* Compliance: The participant must be willing and able to comply with the study schedule, including visits, treatment regimen, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\n* History of Other Malignancies: Participants who have had any other malignancy within 5 years prior to enrollment are excluded, except for those with localized or in situ malignancies such as basal or squamous cell carcinoma, superficial bladder cancer, cervical or breast intraepithelial neoplasia, or other conditions that are considered curable with local therapy.\n* Prior Treatment with PD-1\u002FPD-L1 Inhibitors or Other Immune-Modulating Drugs: Participants who have previously received treatment with PD-1\u002FPD-L1 inhibitors or other drugs targeting T-cell receptors (e.g., CTLA-4, OX-40) or anti-angiogenic agents (e.g., bevacizumab, endostar) are excluded.\n* Systemic Non-Specific Immune Modulation: Participants who have received systemic non-specific immune-modulating therapy (e.g., interleukins, interferons, thymopentin) within 2 weeks prior to the first dose of study drug, or who have used traditional Chinese medicine or herbal preparations with anti-tumor indications within 2 weeks prior to the first dose, are excluded.\n* Active Autoimmune Disease Requiring Systemic Treatment: Participants with active autoimmune diseases requiring systemic treatment (e.g., using disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) are excluded. Substitutive treatments (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered as systemic treatment.\n* Brainstem, Meningeal, or Spinal Metastasis or Compression: Participants with brainstem, meningeal, or spinal metastasis, or with evidence of compression, are excluded.\n* Significant Pleural, Pericardial, or Peritoneal Effusion: Participants with clinically significant pleural, pericardial, or peritoneal effusions requiring diuretic therapy and\u002For repeated drainage are excluded.\n* Gastrointestinal Obstruction or Complications Within 6 Months of First Dose: Participants with a history of clinically significant gastrointestinal obstruction, perforation, intra-abdominal abscess, or fistula formation within 6 months prior to the first dose of study drug are excluded.\n* Active Inflammatory Gastrointestinal Diseases: Participants with active inflammatory gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, radiation enteritis, hemorrhagic enteritis, chronic diarrhea) are excluded.\n* Tumor Encircling Major Vessels or Severe Necrosis\u002FHemorrhage: Participants with imaging findings showing tumor encircling major vessels, significant necrosis, or cavitation, and whose researchers determine that entry into the study would pose a bleeding risk, are excluded.\n* Interstitial Lung Disease ≥ Grade 2: Participants with interstitial lung disease ≥ Grade 2 are excluded.\n* Severe Cardiovascular Disease:\n\nUncontrolled hypertension or pulmonary hypertension; Unstable angina pectoris, myocardial infarction within 6 months prior to the first dose of study drug, coronary artery bypass grafting, or stent implantation; Chronic heart failure with NYHA functional class ≥ 2; Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n\n* Severe arrhythmias requiring drug treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia), such as QTcF \\> 450 msec in males or \\> 470 msec in females, complete left bundle branch block, or third-degree heart block; Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 4 weeks prior to the first dose of study drug.\n* Severe Infection Within 4 Weeks Prior to First Dose: Participants with a history of severe infection (e.g., sepsis, bacteremia, or severe pneumonia) within 4 weeks prior to the first dose of study drug, or who have received systemic antimicrobial therapy for an active infection (excluding antiviral treatment for hepatitis B or C) within 2 weeks prior to the first dose, are excluded.\n* Active Tuberculosis or Syphilis: Participants with known active tuberculosis (TB) or syphilis are excluded. Suspected TB cases must be ruled out with clinical evaluation.\n* Positive HIV Antibody or Active Hepatitis B or C:","75 Years",{"count":87,"type":20},45,[89,23],"PHASE1","A Prospective, Multicenter, Phase Ib\u002FII Trial of Ivonescimab (AK112) Combined with Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma",[92,93,29],"Esophageal Squamous Cell Carcinoma","Ivonescimab",[29,92],"2026-01-29",{"date":97,"type":42},"2026-02-03",{"date":99,"type":20},"2026-01-28",{"date":101,"type":20},"2028-01-28",{"name":103,"class":76},"Tang-Du Hospital",1,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":58,"minAge":17,"maxAge":85,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":123,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":104},"100478631","phase-2-camrelizumab-plus-apatinib-and-temozolomide-as-neoadjuvant-in-high-risk-acral-melanoma-100478631","NCT05512481","Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma","A Phase 2 Clinical Trial of Neoadjuvant Camrelizumab Plus Apatinib and Temozolomide in High Risk Clinical Stage Ⅱ-Ⅲ Acral Melanoma","Inclusion Criteria:\n\n1. age:18-75 years, male or female.\n2. Histopathologically confirmed acral melanoma (stage Ⅱ\u002FⅢ).\n3. Has not received any systematic anti-tumor drug treatment.\n4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.\n5. ECOG 0-1.\n6. Adequate organ function.\n7. Life expectancy of greater than 12 weeks.\n8. Patient has given written informed consent.\n\nExclusion Criteria:\n\n1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.\n2. Known history of hypersensitivity to any component of apatinib, temozolomide, Camrelizumab.\n3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);\n4. Subjects with any active autoimmune disease or history of autoimmune disease\n5. Patients with any unstable systemic disease, including but not limited to: serious infection, uncontrolled diabetes, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, myocardial infarction, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease;\n6. Received a live vaccine within 4 weeks of the first dose of study medication.\n7. Pregnancy or breast feeding.\n8. Decision of unsuitableness by principal investigator or physician-in charge.",{"count":113,"type":20},60,[23],"Neoadjuvant therapy is feasible in stage Ⅱ-Ⅲ melanoma, Carrelizumab combined with apatinib and temozolomide has synergistic antitumor effects and may improve pathological response.",[117,118,119,120,121,29,122],"Melanoma","Acral Melanoma","Temozolomide","Apatinib","Camrelizumab","Pathological Response",[118,124,125,126],"Immune Checkpoint Inhibitors","Protein Kinase Inhibitors","Antineoplastic Agents, Alkylating","2025-02-28",{"date":129,"type":42},"2025-03-03",{"date":131,"type":42},"2022-09-13",{"date":133,"type":20},"2026-12-31",{"name":135,"class":76},"Peking University Cancer Hospital & Institute",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":143,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":104},"100552928","clinical-application-of-ctdna-dynamic-monitoring-in-neoadjuvant-therapy-for-her2-positive-breast-cancer-patients-100552928","NCT06479460","Clinical Application of ctDNA Dynamic Monitoring in Neoadjuvant Therapy for HER2-positive Breast Cancer Patients","Director, Department of Pathology, Jiangsu Provincial People's Hospital","Inclusion Criteria:\n\n1. Women with breast cancer diagnosed clinically and pathologically, aged 18-75 years;\n2. ECOG performance score is 0-1;\n3. Histologically confirmed as early or locally advanced invasive breast cancer: the diameter of the primary tumor is more than 2 cm, and HER2 is positive (confirmed by IHC or FISH).\n4. The patient did not receive any treatment for breast cancer before enrollment;\n5. Having lesions measurable according to RECIST 1.1 standards;\n6. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up; 7) Breast cancer patients who plan to use neoadjuvant therapy.\n\nExclusion criteria\n\n1. Patients with known metastatic or stage IV breast cancer;\n2. There are other untreated malignant tumors other than breast cancer;\n3. Patients with one or more serious systemic diseases that, in the eyes of researchers, can impair their ability to complete research;\n4. According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors, which may affect the safety of the subjects or the collection of experimental data.\n5. Unable to follow up with the study according to the determined clinical follow-up period;\n6. Cannot accept or provide specified efficacy evaluation methods such as CT.\n7. Unable to obtain sufficient tumor tissue samples or peripheral blood samples.\n\nExclusion Criteria:\n\n\\- 1) Patients with known metastatic or stage IV breast cancer; 2) There are other incurable malignant tumors present; 3) One or more serious systemic diseases that, in the eyes of researchers, can impair the patient's ability to complete the study; 4) According to the researcher's judgment, there are other factors that may cause the subject to be forced to terminate the study midway, such as other serious illnesses (including mental illness) requiring concurrent treatment, severe abnormal laboratory test values, family or social factors, which may affect the safety of the subject or the collection of trial data.\n\n5\\) Unable to follow the determined clinical follow-up period in conjunction with the study for follow-up; 6) Unable to accept or provide specified efficacy evaluation methods such as CT.",{"count":144,"type":20},50,"OBSERVATIONAL","1. To explore the predictive value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population;\n2. To evaluate the prognostic value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population.",[148,29,149,150],"Breast Cancer","HER2-positive Breast Cancer","Circulating Tumor DNA",[152,153,154],"breast cancer","circulating tumor DNA","MRD","2024-07-23",{"date":157,"type":42},"2024-07-24",{"date":159,"type":42},"2024-03-08",{"date":161,"type":20},"2026-03-31",{"name":163,"class":76},"The First Affiliated Hospital with Nanjing Medical University",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100516161","phase-2-a-study-of-neoadjuvant-tchpypyrotinib-trastuzumabcarboplatin-and-paclitaxelfor-erher2-breast-cancer-100516161","NCT06000917","A Study of Neoadjuvant TCHpy（Pyrotinib ，Trastuzumab，Carboplatin and Paclitaxel）for ER+\u002FHER2+ Breast Cancer","A Multicenter, Single-arm, Prospective Study of Neoadjuvant Pyrotinib Combined With Trastuzumab，Carboplatin and Paclitaxel for ER+\u002FHER2+ Early or Locally Advanced Breast Cancer","Inclusion Criteria:\n\n* Newly treated female patients aged ≥18 years and ≤75 years;\n* ECOG score 0\\~1;\n* Pathologically diagnosed as HER2-positive breast cancer patients with early or locally advanced tumor stage, primary tumor diameter T≥2cm or lymph node positive;\n* Hormone receptor status (ER and PgR) is known, where ER≥10%\n* Normal function of major organs:\n\n  1. The standard of blood routine examination should meet: ANC ≥1.5×109\u002FL; PLT≥90×109\u002FL; Hb ≥90g\u002FL\n  2. Biochemical examination should meet the following standards: TBIL≤ the upper limit of normal value(ULN); ALT and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL\u002Fmin (CockcroftGault formula);\n  3. Cardiac color ultrasound and echocardiography: left ventricular ejection fraction(LVEF≥55%)\n  4. Fridericia calibrated QT interval (QTcF) for 18-lead ECG \\\u003C470 ms;\n* For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment;\n* Volunteer to join the study and sign the informed consent.\n\nExclusion Criteria:\n\n* Stage IV (metastatic) breast cancer;\n* Inflammatory breast cancer;\n* Previous antitumor therapy or radiation therapy for any malignancies, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma;\n* Also receiving antitumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy;\n* Had a major surgery not related to breast cancer in the 4 weeks prior to enrollment, or had not fully recovered from such surgery;\n* Serious heart disease or discomfort, including but not limited to the following:\n\n  * History of heart failure or systolic dysfunction (LVEF \\\u003C 50%)\n  * High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \\>100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-grade atrioventricular block (i.e. Mobitz II second- degree atrioventricular block or third-degree atrioventricular block\n* Inability to swallow, intestinal obstruction, or other factors affecting the use and absorption of the drug;\n* Known allergic history of the drug components of this protocol; A history of immunodeficiency, including HIV testing positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;\n* Women who are pregnant or nursing, women who are fertile and have a positive baseline pregnancy test, or women of childbearing age who are unwilling to use effective contraception throughout the trial period and within 7 months after the last study medication;\n* Have a serious concomitant condition or other comorbid condition that interferes with planned treatment, or any other condition in which the investigator deems the patient unsuitable for participation in the study.",{"count":172,"type":20},62,[23],"This study is a multicenter, single-arm, prospective, open clinical study to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, albumin paclitaxel, and carboplatin in neoadjuvant therapy for ER+\u002FHER2+ early or locally advanced breast cancer.",[148,29],"2023-08-18",{"date":178,"type":42},"2023-08-21",{"date":180,"type":42},"2023-05-11",{"date":182,"type":20},"2028-05-11",{"name":184,"class":76},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",2,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":58,"minAge":17,"maxAge":59,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":195,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":104},"100434172","phase-2-prospective-multicenter-clinical-study-of-neoadjuvant-imatinib-mesylate-for-gastrointestinal-stromal-tumors-100434172","NCT04933669","Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors","ZJGIST-01","Inclusion Criteria:\n\n* Preoperative histologically confirmed primary gastrointestinal stromal tumor\n* Tumor must stain positive for c-Kit (CD117) and\u002For discovered on gist-1 (DOG-1) by immunohistochemistry\n* Gene mutation test report including c-kit exons 9,11,13 and 17 and platelet-derived growth factor receptor alpha (PDGFRA) exons 12 and 18\n* High risk GIST (as modified National Institutes of Health (NIH) 2008): stomach (maximum tumor diameter\\> 10.0cm), nonstomach (maximum tumor diameter\\> 5.0cm)\n* Gender is not limited. Age: ≥ 18 years and ≤ 80 years old\n* Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1\n* Patient had informed consent and signed a written consent form\n\nExclusion Criteria:\n\n* Asp842Val (D842V) mutation in Exon 18 of PDGFRA gene, or wild type (c-kit exon 9,11,13,17, and PDGFRA Exon 12,18), or c-kit exon 9 mutation\n* Treated with tyrosine kinase inhibitors including Imatinib\n* Aspartate aminotransferase (AST) and\u002For Alanine aminotransferase (ALT)\\>2.5×ULN(upper limit of normal)，or Total bilirubin (TBIL)\\>1.5×ULN，or Creatinine (Cr)\\>1.0×ULN\n* Absolute neutrophil count (ANC) \\\u003C 1.5 × 10 \\^ 9 \u002F L；or Platelet count (PLT) \\\u003C 75 × 10 \\^ 9 \u002F L；or Hemoglobin (Hb) ≥ 90 g \u002F L\n* Previous or concurrent other active malignant tumors (except for basal cell carcinoma of the skin, or cervical cancer in situ that has undergone curative therapy)\n* Distant metastases are present\n* Any of the following conditions during the 12 months prior to entry: myocardial infarction, severe \u002F unstable angina, coronary artery \u002F peripheral artery bypass surgery, symptomatic congestive heart failure, or cerebrovascular accidents\n* positive Human Immunodeficiency Virus (HIV) antibody\n* Currently participating in other clinical trials\n* Pregnant or lactating women or have fertility without taking contraception\n* Suffering from other serious acute and chronic physical or mental problems, or abnormal laboratory tests, will increase the risk of participation or drug use, or interfere with the judgment of the findings, judged by the researchers as participate in the study",{"count":194,"type":20},122,[23],"The R0 resection rate of gastrointestinal stromal tumor (GIST) with high recurrence risk was relatively low, and the relapse-free survival rate was relatively low, which needed to be further improved. A few retrospective analyses and a small sample of prospective studies have found that neoadjuvant therapy with imatinib mesylate can improve R0 resection rates. Whether neoadjuvant therapy prolongs long-term survival remains unclear. The primary objective of this study was to evaluate 5-year progression-free survival (PFS) for GIST patients with high recurrence risk after neoadjuvant treatment with imatinib mesylate.",[198,199,29],"Progression-free Survival","Gastrointestinal Stromal Tumor",[201,202,203],"Progression-free survival","Gastrointestinal Stromal Tumors","neoadjuvant","2021-10-09",{"date":206,"type":42},"2021-10-12",{"date":208,"type":42},"2021-09-07",{"date":210,"type":20},"2029-12-31",{"name":212,"class":76},"First Affiliated Hospital of Zhejiang University"]