[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575004":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":28,"locations":37,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":40,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stereotactic body radiation therapy group","EXPERIMENTAL",null,[13],"Procedure: Stereotactic Body Radiation Therapy (SBRT)",{"label":15,"type":10,"description":11,"interventionNames":16},"Radiofrequency ablation therapy group",[17],"Procedure: Radiofrequency ablation therapy",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"PROCEDURE","Stereotactic Body Radiation Therapy (SBRT)","Stereotactic radiosurgery for liver lesions: with a total dose of 40\\~50Gy\u002F3\\~5fraction;",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Radiofrequency ablation therapy","Radiofrequency ablation therapy:1 complete radiofrequency ablation of liver lesions for liver lesions",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Song Tianqiang T Song, MD","CONTACT","+86 18622221077","tjchi@hotmail.com",{"name":35,"role":31,"phone":36,"phoneExt":11,"email":11},"Meng Maobin M Meng, MD","+86 18526065681",[38],{"facility":39,"status":40,"city":41,"state":11,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Department of Hepatobiliary Oncology and Radiation Oncology,Tianjin Medical University Cancer Institute & Hospital,Key Laboratory of Cancer Prevention and Therapy,National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer","RECRUITING","Tianjin","300060","China","CN",{"type":46,"coordinates":47},"Point",[48,49],117.17667,39.14222,{"lat":49,"lon":48},[52,53,56],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},{"name":54,"role":31,"phone":36,"phoneExt":11,"email":55},"Meng Maobin M, MD","mmeng@tmu.edu.cn",{"name":57,"role":58,"phone":11,"phoneExt":11,"email":11},"Sun Liyu L Sun, MM","SUB_INVESTIGATOR",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100575004","phase-2-stereotactic-radiosurgery-versus-radiofrequency-ablation-for-primary-liver-cancer-100575004",false,"NCT06766643","Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer","A Prospective, Randomized, Controlled Phase II Clinical Trial of Stereotactic Radiosurgery Versus Radiofrequency Ablation in Primary Liver Cancer in a Special Site of Surgical Evaluation for Non-operable","Inclusion Criteria:\n\n1. Prior to implementing any trial-related procedures, written informed consent must be signed;\n2. Age ≥ 18 years and ≤ 75 years;\n3. Child-Pugh score ≤ 7;KPS score ≥ 70;\n4. The patient must be clearly diagnosed with hepatocellular carcinoma, usually confirmed through imaging (CT, MRI) or histological examination (biopsy);\n5. The tumor is located near major blood vessels\u002Fdiaphragm\u002Fliver capsule\u002Fliver hilum;\n6. Surgically assessed as inoperable hepatocellular carcinoma or recurrence of primary hepatocellular carcinoma within 2 years after radical treatment;\n7. According to the criteria for evaluating the efficacy of solid tumors, there should be at least one measurable lesion by imaging, with the lesion size not exceeding 5 cm; total number of lesions ≤ 3;\n8. No previous anti-tumor treatment;\n9. Normal liver (liver volume minus tumor volume) is sufficient;\n10. Normal major organ functions, including blood routine tests \\[absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9, platelets ≥ 70 × 10\\^9, hemoglobin ≥ 80 g\u002FL\\], liver function tests \\[bilirubin \\\u003C 3.0 mg\u002FdL, international normalized ratio (INR) \\\u003C 1.7, albumin ≥ 2.8 g\u002FdL, aspartate transaminase (AST)\u002Falanine transaminase (ALT) \\\u003C 6\\], serum creatinine \\\u003C 1.5 times the upper limit of normal, or creatinine clearance ≥ 60 mL\u002Fmin;\n11. Stable respiration for more than 10 minutes;\n12. Expected survival time \\> 2 years.\n\nExclusion Criteria:\n\n1. Possible surgical intervention;\n2. Presence of other serious comorbidities, such as uncontrolled cardiovascular diseases, pulmonary diseases, or dysfunction of other organs, where the overall health status is poor and may result in treatment intolerance;\n3. Severe liver dysfunction exceeding the specific criteria defined in the trial;\n4. Other malignancies diagnosed within 5 years prior to the first treatment or at the time of diagnosis of hepatocellular carcinoma;\n5. Significant clinically meaningful bleeding symptoms or a clear bleeding tendency within 3 months prior to enrollment;\n6. Currently participating in an interventional clinical trial treatment, or having received other investigational drugs or used investigational devices within 4 weeks before the first treatment;\n7. Previous treatment with anti-target tumor therapies;\n8. History of upper abdominal radiotherapy;\n9. Uncontrolled active comorbidities;\n10. Not meeting the expected survival prognosis or unable to provide informed consent.","ALL","18 Years","75 Years",{"count":72,"type":73},130,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites",[79],"Primary Liver Cancer",[81],"Primary liver cancer，Stereotactic body radiation therapy，Radiofrequency ablation therapy","2025-01-08",{"date":84,"type":85},"2025-01-09","ACTUAL",{"date":87,"type":73},"2025-01",{"date":89,"type":73},"2026-12",{"name":5,"class":6},1]