[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608153":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":23,"locations":22,"responsibleParty":29,"collaborators":22,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":35,"sex":41,"minAge":42,"maxAge":43,"enrollmentInfo":44,"targetDuration":22,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":22,"overallStatus":55,"whyStopped":22,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":22},{"fullName":5,"class":6},"Qianfoshan Hospital","OTHER",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"MWA + huaier","EXPERIMENTAL",[12],"Drug: Huaier Granule",{"label":14,"type":10,"description":14,"interventionNames":15},"MWA",[12],[17],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Huaier Granule","Patients in this arm will undergo CT-guided percutaneous microwave ablation using a standard protocol (2450 MHz, 30-50 W, 5-10 minutes per lesion, multi-probe as needed based on tumor size). Seven days post-ablation, patients will start oral administration of Huaier granules at a dose of 10g, three times daily (TID), for 72 consecutive weeks. The combined therapy aims to improve local tumor control and modulate anti-tumor immunity.",[14,9],null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Nan Wang, Doctor","CONTACT","86-15864028114","drwangnan@126.com",{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"SPONSOR_INVESTIGATOR","Xin Ye","professor","100608153","phase-3-clinical-efficacy-and-safety-of-microwave-ablation-combined-with-huaier-granules-in-patients-with-inoperable-stage-ia-non-small-cell-lung-cancer-a-prospective-single-center-randomized-controlled-clinical-trial-100608153",false,"NCT07197853","Clinical Efficacy and Safety of Microwave Ablation Combined With Huaier Granules in Patients With Inoperable Stage IA Non-Small Cell Lung Cancer: A Prospective, Single-Center, Randomized Controlled Clinical Trial","A Prospective, Single-Center, Randomized Controlled Trial to Evaluate the Clinical Efficacy and Safety of Microwave Ablation Combined With Huaier Granules in Patients With Stage IA Non-Small Cell Lung Cancer","HAMSTER","Inclusion Criteria\n\nAge:\n\n≥ 18 years old.\n\nDiagnosis:\n\nHistologically or cytologically confirmed IA stage non-small cell lung cancer (NSCLC) that is inoperable.\n\nECOG Performance Status:\n\n0-2 (Eastern Cooperative Oncology Group performance status).\n\nPrevious Treatment:\n\nPatients must have received no prior systemic treatment for lung cancer.\n\nInformed Consent:\n\nAbility to provide written informed consent and willingness to comply with study requirements.\n\nAdequate Organ Function:\n\nPatients must have adequate hepatic, renal, and hematologic function as evidenced by:\n\nBilirubin ≤ 1.5 × upper limit of normal (ULN)\n\nALT\u002FAST ≤ 2.5 × ULN\n\nCreatinine clearance ≥ 30 mL\u002Fmin\n\nAbsolute neutrophil count (ANC) ≥ 1,500 cells\u002FμL\n\nExclusion Criteria\n\nOther Malignancies:\n\nActive or history of other malignancies within the past 5 years, except for non-melanoma skin cancer or in situ carcinoma.\n\nSevere Concurrent Diseases:\n\nAny serious or uncontrolled medical condition such as:\n\nCardiovascular disease (e.g., recent myocardial infarction, unstable angina, or severe arrhythmia)\n\nUncontrolled diabetes or hypertension\n\nActive infections requiring systemic antibiotics or antivirals\n\nPregnancy or Breastfeeding:\n\nWomen who are pregnant, breastfeeding, or planning to become pregnant during the study.\n\nImmunosuppressive Therapy:\n\nPatients who have received immunosuppressive therapy within 30 days prior to enrollment.\n\nOther Contraindications:\n\nKnown hypersensitivity to any of the components of the treatment regimen (e.g., microwave ablation, Huai Er Granules).\n\nOther Unspecified Conditions:\n\nAny other condition or circumstances that, in the investigator's opinion, may interfere with the study or pose a risk to the patient.\n\n\\-","ALL","18 Years","80 Years",{"count":45,"type":46},180,"ESTIMATED","INTERVENTIONAL",[49],"PHASE3","This prospective, single-center, randomized controlled clinical trial aims to evaluate the efficacy and safety of microwave ablation (MWA) combined with Huaier granules in patients with inoperable stage IA non-small cell lung cancer (NSCLC). A total of 180 eligible patients will be randomly assigned to receive either MWA alone or MWA combined with Huaier granules. The primary endpoint is progression-free survival (PFS) assessed by RECIST 1.1 criteria. Secondary outcomes include local progression rate (LPR), overall survival (OS), tumor markers, immune function, and quality of life. Safety will be evaluated using the CTCAE v5.0 criteria. The study seeks to determine whether the combined therapy offers improved tumor control and immune benefits over MWA alone.",[52,53,54],"Non-small Cell Lung Cancer (NSCLC)","Huaier Granules","Microwave Ablation","NOT_YET_RECRUITING","2025-09-26",{"date":58,"type":59},"2025-09-29","ACTUAL",{"date":61,"type":46},"2025-10-01",{"date":63,"type":46},"2028-06-30",{"name":31,"class":6}]