[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stereotactic-body-radiotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stereotactic-body-radiotherapy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,41,72,101,130,159,182,210,238],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100579499","phase-3-is-adaptive-sbrt-for-prostate-vs-image-guided-radiotherapy-a-true-evolution-aspire-100579499",false,"NCT06825091","Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)","ASPIRE","Inclusion Criteria:\n\n1. Age \\>18 years\n2. Histologic diagnosis of prostate adenocarcinoma\n3. Localized prostate cancer\n4. Low risk, intermediate risk, or high risk allowed\n5. Patient planned for prostate SBRT\n\nExclusion Criteria:\n\n1. Planned for elective nodal irradiation\n2. Contraindications to radiotherapy\n3. Patients with bilateral hip replacements, as they are ineligible for adaptive treatments at present time (either MR-guided or CT-guided)","MALE","18 Years",{"count":19,"type":20},320,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The ASPIRE study is a Phase III randomized, single-center study designed to evaluate whether adaptive stereotactic body radiotherapy (SBRT) offers superior clinical benefits compared to standard image-guided SBRT for patients with localized prostate cancer. It aims to explore whether adaptive SBRT can improve urinary outcomes while maintaining effective cancer control.\n\nThis interventional study is randomized, single-institution, and includes 320 participants with localized prostate cancer. Patients will be stratified based on fractionation schedules (5 vs. 7 fractions), use of rectal spacers, androgen deprivation therapy (ADT), and baseline alpha receptor antagonist use. Participants will be randomized to receive either adaptive SBRT or standard image-guided SBRT, with both arms adhering to established dosing protocols.\n\nInclusion criteria includes an age greater than 18 years, diagnosed with localized prostate adenocarcinoma, and an ECOG performance status of 0-1, Eligible for prostate SBRT. The exclusion criteria includes patients who plan for elective nodal irradiation and contraindications to radiotherapy or MRI (for MR-Linac patients).",[26,27],"Localized Prostate Cancer","Stereotactic Body Radiotherapy","RECRUITING","2026-05-29",{"date":31,"type":32},"2026-06-02","ACTUAL",{"date":34,"type":32},"2025-02-04",{"date":36,"type":20},"2030-02-04",{"name":38,"class":39},"University Health Network, Toronto","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100639385","phase-3-neoadjuvant-sf-sbrt-plus-toripalimab-and-chemotherapy-in-resectable-stage-ii-iii-nsclc-100639385","NCT07608159","Neoadjuvant SF-SBRT Plus Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC.","A Randomized, Controlled, Multicenter Phase III Clinical Study of Spatially Fractionated Stereotactic Body Radiotherapy Plus Toripalimab and Chemotherapy Versus Toripalimab Plus Chemotherapy in Patients With Resectable or Potentially Resectable Stage II-III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Male or female participants aged 18 to 75 years;\n* Eastern Cooperative Oncology Group performance status of 0 or 1;\n* Previously untreated, pathologically confirmed, resectable or potentially -resectable stage II, IIIA, or IIIB (N2) non-small cell lung cancer according to the 8th edition of the American Joint Committee on Cancer staging system;\n* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1;\n* Adequate pulmonary function, as assessed by the surgeon, to tolerate the planned lung resection;\n* Absence of sensitizing EGFR mutations or ALK rearrangements confirmed by tissue-based molecular pathological testing;\n* Adequate organ function, defined as follows:\n\nBone marrow function: absolute neutrophil count ≥1.5 × 10\\^9\u002FL, platelet count ≥80 × 10\\^9\u002FL, and hemoglobin ≥9 g\u002FdL; Liver function: total serum bilirubin ≤1.5 × upper limit of normal; alanine aminotransferase and aspartate aminotransferase ≤1.5 × upper limit of normal; Renal function: serum creatinine ≤1.5 × upper limit of normal or creatinine clearance ≥60 mL\u002Fmin, and blood urea nitrogen ≤200 mg\u002FL;\n\n* Participants must be fully informed about the study and voluntarily sign the written informed consent form.\n* Male participants with reproductive potential or female participants of childbearing potential must agree to use effective contraception during the study, such as oral contraceptives, an intrauterine device, or a barrier method combined with spermicide, and continue contraception for 6 months after completion of treatment.\n\nExclusion Criteria:\n\n* Locally advanced unresectable or metastatic disease. Unresectable disease is defined according to the multidisciplinary consensus for stage III non-small cell lung cancer (2019 edition), including some stage IIIA, stage IIIB, and all stage IIIC disease. This usually includes N2 disease with a single-station mediastinal lymph node with a short-axis diameter ≥3 cm, or multistation lymph node fusion\u002Fconglomeration with lymph nodes having a short-axis diameter ≥2 cm on CT; T4 disease invading the esophagus, heart, aorta, or pulmonary veins; and all N3 disease;\n* Non-small cell lung cancer involving the superior sulcus, large-cell neuroendocrine carcinoma, or sarcomatoid carcinoma;\n* Known sensitizing EGFR mutation or ALK rearrangement. For participants with non-squamous histology, EGFR and ALK mutation status must be confirmed;\n* Prior treatment with PD-1 or PD-L1 inhibitors, or agents targeting another T-cell receptor pathway, such as CTLA-4 or OX-40;\n* Active or suspected active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, and inflammatory bowel disease. Exceptions include type 1 diabetes mellitus or hypothyroidism controlled with stable replacement therapy, and dermatologic conditions not requiring systemic treatment, such as psoriasis or vitiligo;\n* History of interstitial lung disease of grade 2 or higher;\n* Use of systemic corticosteroids, defined as prednisone \\>10 mg\u002Fday or equivalent, or other immunosuppressive medications within 14 days before the first dose of study treatment;\n* History of immunodeficiency, including acquired or congenital immunodeficiency disorders, history of organ transplantation, or prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;\n* Receipt of a live vaccine within 4 weeks before the first dose of study treatment;\n* Severe cardiovascular or cerebrovascular disease, including:\n\nPoorly controlled hypertension or pulmonary hypertension;\n\n* Unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation within 6 months before study treatment;\n* Chronic heart failure with New York Heart Association class II or higher cardiac function;\n* Left ventricular ejection fraction \\\u003C50%;\n* Severe arrhythmias requiring medical treatment, except atrial fibrillation or paroxysmal supraventricular tachycardia. Examples include QTcF \\>450 msec in males or \\>470 msec in females, complete left bundle branch block, or third-degree atrioventricular block;\n* Cerebrovascular accident or transient ischemic attack within 6 months before study treatment;\n* Uncontrolled or severe underlying medical conditions, including but not limited to active infection requiring systemic antibiotic therapy;\n* Positive human immunodeficiency virus antibody test, active hepatitis B, or active hepatitis C. The following participants may be eligible:\n* Participants positive for hepatitis B core antibody or hepatitis B surface antigen may be enrolled if HBV DNA is below the lower limit of detection at the study site, or \\\u003C500 IU\u002FmL, and active infection is excluded by the investigator based on clinical treatment history and clinical manifestations;\n* Participants positive for hepatitis C antibody may be enrolled if HCV RNA is below the lower limit of detection at the study site;\n* Known active pulmonary tuberculosis. Participants suspected of having active tuberculosis must undergo chest X-ray, sputum examination, and assessment of clinical symptoms and signs to exclude active tuberculosis;\n* History of any active malignancy other than the study disease within 2 years before enrollment, except malignancies expected to be cured after treatment, including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery;\n* History of psychotropic drug abuse that cannot be discontinued, or history of psychiatric disorder;\n* Pregnant or breastfeeding women;\n* Any other severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that, in the investigator's judgment, may increase the risk associated with study participation or may interfere with interpretation of the study results.","ALL","75 Years",{"count":51,"type":20},201,[23],"This is an open-label, randomized, controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of spatially fractionated stereotactic body radiotherapy (SF-SBRT) combined with toripalimab and platinum-based chemotherapy versus toripalimab combined with platinum-based chemotherapy in patients with resectable or potentially resectable stage II-III non-small cell lung cancer (NSCLC). Eligible participants will be randomized 2:1 to receive either neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy for two cycles, or toripalimab and platinum-based chemotherapy for three cycles. Randomization will be stratified by disease stage and histological subtype. Surgery is planned 4-6 weeks after completion of neoadjuvant treatment, and postoperative adjuvant therapy will be determined by the investigator. The primary endpoint is the 2-year event-free survival rate. Secondary endpoints include pathological complete response rate, major pathological response rate, objective response rate, R0 resection rate, event-free survival, overall survival, and safety. Adverse events will be assessed according to NCI CTCAE version 5.0 or later.",[55,27,56,57],"Non Small Cell Lung Cancer","Neoadjuvant Chemoimmunotherapy","Surgery",[59,60,61,62],"Spatially fractionated radiotherapy","stereotactic body radiotherapy","non small cell lung cancer","neoadjuvant chemoimmunotherapy","NOT_YET_RECRUITING","2026-05-27",{"date":29,"type":32},{"date":67,"type":20},"2026-05",{"date":69,"type":20},"2030-05",{"name":71,"class":39},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100615210","phase-3-functional-lung-avoidance-planning-guided-by-lung-perfusion-petct-versus-anatomical-planning-for-lung-stereotactic-body-radiotherapy-100615210","NCT07289646","Functional Lung Avoidance Planning Guided by Lung Perfusion PET\u002FCT Versus Anatomical Planning for Lung Stereotactic Body Radiotherapy","Pegasus 2","Inclusion Criteria:\n\n* Patients aged \\> 18 years planned to be treated in the radiotherapy department of the participating centers with SBRT for primary or secondary lung tumors will be eligible to participate into the study\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Patientsunder guardianship or curatorship\n* Pregnant or breastfeeding women.\n* Contraindications to the radiolabeled product infused for lung perfusion PET\u002FCT.",{"count":80,"type":20},418,[23],"Stereotactic body radiotherapy (SBRT) has an increasing role in the treatment of both primary and secondary lung tumors. However, lung SBRT remains associated with significant radiation induced lung injury (RILI). Indeed, the reported incidence of symptomatic radiation induced lung injury (grade≥2) in the published literature is up to 20%. A current challenge of lung SBRT is therefore to better preserve lung function and to reduce pulmonary toxicity.\n\nDuring standard lung SBRT planning, dose constraints are defined on the anatomical lung volume. This planning considers the lung as functionally uniform and does not take into account the variability of regional lung function distribution. Functional lung avoidance is an emerging concept in lung radiotherapy (RT). The technique aims at personalizing RT treatment planning to individuals' lung functional distribution, by sparing functional pulmonary areas while prioritizing delivery of high doses to non-functional regions.\n\n68Ga-MAA lung perfusion PET\u002FCT is a novel imaging modality for regional lung function assessment. As compared with conventional lung scintigraphy, lung perfusion PET\u002FCT is inherently a vastly superior technology for image acquisition (higher sensitivity and spatial resolution, greater access to respiratory gated acquisition). A more accurate lung functional mapping improves the possibility of functional lung avoidance planning for SBRT.\n\nThe hypothesis is that functional lung avoidance planning guided by 68Ga-MAA perfusion PET\u002FCT, while delivering an optimal dose to the tumor, will reduce the frequency of RILI in patients treated with lung SBRT.",[27,84,85],"68Ga-MAA","Lung Cancer (Diagnosis)",[87,88,89,90],"Stereotactic body radiotherapy","68Ga-MAA lung perfusion","PET\u002FCT","lung radiotherapy","2026-01-13",{"date":93,"type":32},"2026-01-14",{"date":95,"type":20},"2026-01-15",{"date":97,"type":20},"2029-05-15",{"name":99,"class":39},"University Hospital, Brest",2,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":126,"leadSponsor":128,"locationsCount":40},"100614895","stereotactic-body-radiotherapy-with-continuous-tracking-for-primary-and-secondary-renal-cancer-100614895","NCT07285538","Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer","A Prospective Interventional Study of Stereotactic Body RadioTherapy (SBRT) With Continuous Tracking for Inoperable Patients With Primary and Secondary Renal Cancer (SBRTRC)","SBRTRC","Inclusion Criteria:\n\n1. Histological or clinical diagnosis of primary or secondary kidney tumors\n2. Patients aged ≥18 years\n3. Signed informed consent\n4. Tumor up to 10 cm in the greatest diameter (sum of diameters in case of multiple lesions)\n5. PS (ECOG) ≤2\n6. No prior local radiotherapy\n7. Fertile women using contraception methods previously initiated (a pregnancy test will be prescribed)\n\nExclusion Criteria:\n\n1. Patients aged \\\u003C 18 years\n2. Tumors \\> 10 cm\n3. PS ECOG ≥3\n4. Psychiatric or other disorders that may prevent the patient from signing informed consent\n5. Previous invasive cancer, except for skin cancer (excluding melanoma) unless the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the oral cavity or bladder)\n6. Pregnant women\n7. Collagen diseases\n8. Sjogren's syndrome",{"count":110,"type":20},60,[112],"NA","This is a prospective, interventional, monocentric, clinical study of Stereotactic Body Radiation Therapy (SBRT) for primary or secondary renal tumors, delivering from 25-26 Gy\u002F1 fraction to 42-48 Gy\u002F3-4 fractions or 40-50 Gy\u002F5 fractions (standard prescriptions for the internationl guidelines, according to tumor size), using a robotic accelerator -CyberKnife® (Accuray, Sunnyvale, CA)-, with fiducial-tracking, to observe the acute and late toxicity reduction (as primary objectives), due to the maximum precision of the treatment. Secondary objectives are Local Relpase-Free Survival (LRFS), Regional Relapse-Free Survival (RRFS), Distant Metastasis-Free Survival (DMFS), Disease-Free Survival (DFS), Cancer Specific Survival (CSS), Overall Survival (OS) and Quality-of-Life (QoL). A total of 60 participants are expected to be enrolled over four years, and the follow-up of enrolled patients will be three years.",[115,116,27],"Renal Cancer","Renal Secondary Cancer",[118,119,60,120,121],"Renal primary tumors","Renal secondary tumors","stereotactic ablative radiotherapy","Renal toxicity","2025-12-12",{"date":124,"type":32},"2025-12-16",{"date":95,"type":20},{"date":127,"type":20},"2033-01-15",{"name":129,"class":39},"IRCCS San Raffaele",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":141,"conditions":142,"keywords":147,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":40},"100557749","phase-2-elimination-of-ptv-margins-based-on-online-adaptive-stereotactic-radiotherapy-for-early-stage-non-small-cell-lung-cancer-or-pulmonary-oligometastases-100557749","NCT06542159","Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases","Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases: a Prospective, Randomized, Controlled Phase II Study","Inclusion Criteria:\n\n* Histologically or PET-CT confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0) that is inoperable or where the patient is unwilling to undergo surgery, or PET-CT\u002Fchest CT confirmed lung oligometastases (number of metastases ≤3, single lesion diameter ≤5cm).\n* Age 18 years or older, regardless of gender.\n* ECOG performance status score of 0-2.\n* Serum hemoglobin ≥ 80 g\u002FL, platelets ≥ 100,000\u002FμL, absolute neutrophil count ≥ 1,500\u002FμL.\n* Serum creatinine ≤ 1.25 times the upper normal limit (UNL) or creatinine clearance ≥ 60 ml\u002Fmin.\n* Serum bilirubin ≤ 1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL.\n* FEV1 ≥ 0.5 L.\n* Normal CB6 range.\n* The patient and their family agree and sign the informed consent form.\n\nExclusion Criteria:\n\n* Tumors with bronchial invasion are excluded.\n* Any other disease or condition that contraindicates radiotherapy (e.g., active infections, within 6 months post-myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmias).\n* Pregnant or breastfeeding women, women who have not undergone pregnancy testing, and pregnant individuals.\n* Individuals with substance abuse issues, chronic alcoholism, or AIDS.\n* Individuals with uncontrollable seizures or loss of self-control due to psychiatric disorders.\n* Individuals with a history of severe allergies or specific sensitivities.",{"count":138,"type":20},130,[140],"PHASE2","This study aims to explore the safety and efficacy of eliminating the PTV (planning target volume) margins based on online adaptive stereotactic radiotherapy for patients with early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases.",[143,27,144,145,146],"Adaptive Radiotherapy","Non-small Cell Lung Cancer","Lung Oligometastases","Toxicity",[148,87,144,149,146],"Online adaptive radiotherapy","Lung oligometastases","2025-11-13",{"date":152,"type":32},"2025-11-17",{"date":154,"type":32},"2024-05-22",{"date":156,"type":20},"2028-04-21",{"name":158,"class":39},"Sun Yat-sen University",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":40},"100574510","safety-and-efficacy-of-preoperative-sbrt-and-radical-surgery-for-soft-tissue-sarcoma-of-extremities-100574510","NCT06760221","Safety and Efficacy of Preoperative SBRT and Radical Surgery for Soft Tissue Sarcoma of Extremities","Safety and Efficacy of Preoperative Stereotactic Body Radiotherapy (SBRT) and Radical Surgery for Soft Tissue Sarcoma of Extremities","Inclusion Criteria:\n\n1. Aged ≥18 years;\n2. Confirmed diagnosis of soft tissue sarcomas;\n3. Highly malignant soft tissue sarcomas;\n4. Not received surgery, chemotherapy or other antitumor therapy;\n5. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;\n6. Signed informed consent;\n7. Willing to provide tissue from an excisional biopsy of a tumor lesion，willing to provide blood sample before and after treatment;\n\nExclusion Criteria:\n\n1. Patients with soft tissue sarcoma of extremities with shallow tumor location, small size, low grade pathology and operable surgical resection;\n2. Distant metastasis;\n3. Received surgery or chemotherapy or other antitumor therapy;\n4. Previously participated in other clinical trials;\n5. History of severe allergies, patients with allergic conditions, such as contrast agent allergy;\n6. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.\n7. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy;\n8. Active infection requiring systemic therapy;\n9. Known psychiatric or substance abuse disorders ;\n10. Pregnant or breastfeeding;\n11. Known history of human immunodeficiency virus (HIV: HIV 1\u002F2 antibodies);\n12. Received a live vaccine within 30 days before radiotherapy.\n13. Unable to lie flat.","80 Years",{"count":168,"type":20},20,[112],"Currently, the effectiveness and safety of preoperative hypo-fractionated radiotherapy in treating extremity soft tissue sarcomas remain inconclusive, warranting further investigation. Optimizing the neoadjuvant radiotherapy approach, including fractionation schedules and the interval between radiotherapy and surgery, is crucial to enhancing clinical efficacy while ensuring safety. This study proposes a multicenter, prospective, single-arm clinical trial utilizing preoperative SBRT for patients with high-grade extremity STS, tumors larger than 5 cm, or cases where achieving safe surgical margins is challenging due to involvement of surrounding blood vessels or nerves. The trial aims to preliminarily assess the impact of preoperative SBRT followed by radical surgery on surgical safety, quality of life, and tumor control in these patients.",[172,27,57],"Soft Tissue Sarcoma","2024-12-29",{"date":175,"type":32},"2025-01-06",{"date":177,"type":32},"2023-03-23",{"date":179,"type":20},"2029-12-31",{"name":181,"class":39},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":48,"minAge":190,"maxAge":166,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":193,"briefSummary":194,"conditions":195,"keywords":198,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":40},"100561818","atezolizumab-and-bevacizumab-with-stereotactic-body-radiotherapy-for-advanced-hepatocellular-carcinoma-100561818","NCT06595108","Atezolizumab and BEvacizumab With STereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma","Atezolizumab and Bevacizumab With Stereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma","A-BEST","Inclusion Criteria:\n\n1. Age 19 to 80 years old\n2. Liver function Child-Pugh class A\n3. ECOG 0-1\n4. Patient clinically or pathologically diagnosed with hepatocellular carcinoma\n5. Advanced hepatocellular carcinoma that is inoperable\n6. Satisfies the dose limits for normal organs and lesions of an appropriate size to be included in the scope of radiotherapy.\n\nExclusion Criteria:\n\n1. Brain metastases\n2. Have a history of malignancy other than hepatocellular carcinoma within the last 5 years (except for malignancies with little risk of metastasis or death, e.g., adequately treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, tubular carcinoma in situ, or stage 1 uterine cancer.)\n3. Subjects with a high probability of untreated gastric or esophageal varices or bleeding\n4. Serious uncontrolled medical comorbidities\n5. History of liver transplant surgery\n6. Autoimmune liver disease","19 Years",{"count":192,"type":20},33,[112],"To determine the efficacy and safety of atezolizumab-bevacizumab combination therapy plus stereotactic body radiotherapy(SBRT) in patients with advanced hepatocellular carcinoma, Subjects will start SBRT for one or more primary cancers and\u002For metastatic lesions and no more than 5 sites within two month before and after the start date of atezolizumab-bevacizumab combination therapy.\n\nIn this study, it is expected to improve the treatment response rate of atezolizumab-bevacizumab therapy, which is currently first-line chemotherapy but has a low treatment response rate.",[196,197,27],"Advanced Hepatocellular Carcinoma","Chemotherapy",[199,200],"atezolizumab-bevacizumab","SBRT","2024-10-30",{"date":203,"type":32},"2024-11-01",{"date":205,"type":32},"2024-05-28",{"date":207,"type":20},"2028-03-27",{"name":209,"class":39},"Yonsei University",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":166,"enrollmentInfo":218,"targetDuration":4,"studyType":21,"phases":220,"briefSummary":221,"conditions":222,"keywords":224,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":40},"100500930","single-ultra-high-dose-stereotactic-body-radiation-therapy-for-early-lung-cancer-100500930","NCT05802654","Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer","Clinical Study of Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer","USBRT-1","Inclusion Criteria:\n\n1. Signed written informed consent;\n2. Male or female aged ≥ 18 years and ≤ 75 years;\n3. patients with early stage lung cancer confirmed by pathology or clinical MDT;\n4. The physical state score (ECOG PS) of the eastern tumor cooperative group was 0 \\~ 1;\n5. Expected survival time ≥3 months;\n6. Laboratory results during screening must meet the following requirements:\n\n   1. Blood routine: neutrophil absolute count (ANC) ≥ 1.5 × 109\u002FL, platelet count (PLT) ≥ 100 × 109\u002FL, hemoglobin (HGB) ≥ 90 g\u002FL (no blood transfusion or erythropoietin dependence within 7 days);\n   2. Liver function: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 2.5 times ULN in subjects without liver metastasis, and ALT and AST were less than 5 times ULN in subjects with liver metastasis.\n   3. Renal function: serum creatinine (Cr) ≤1.5 times ULN or Cr clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula), and urine protein (UPRO) \\&lt on routine urine test; 2+ or 24 h urinary protein quantification \\< 1g;\n   4. International standardized ratio (INR) ≤1.5 times ULN and partial prothrombin time (PTT) or activated partial thrombin time (APTT) ≤1.5 times ULN during the 7 days prior to treatment;\n7. For female subjects of reproductive age, urine or serum pregnancy tests should be negative within 3 days prior to receiving the first fraction of SBRT. If the urine pregnancy test results cannot be confirmed negative, a blood pregnancy test is requested;\n8. Compliance with the research protocol is expected to be good.\n\nExclusion Criteria:\n\n1. currently participating in an interventional clinical trial;\n2. any unstable systemic disease, including but not limited to active infection, congestive heart failure \\[New York Heart Association (NYHA) class ≥ II\\], severe arrhythmia requiring medical therapy, liver, kidney, or metabolic disease; Type I and type II respiratory failure;\n3. other malignancies within 5 years before randomization, except adequately treated cervical carcinoma in situ, basal cell or squamous skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or papillary thyroid cancer;\n4. women who are pregnant or breastfeeding or who plan to become pregnant or breastfeeding during the study period;",{"count":219,"type":20},100,[112],"The goal of this prospective single-arm phase II study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) for early lung cancer. The main questions it aims to answer are:\n\nHow effective is this regimen of SBRT for early lung cancer? How safe is this regimen of SBRT for early lung cancer?",[223,27],"Early Lung Cancer",[225,226,227,228],"lung cancer","Stereotactic body radiotherapy (SBRT)","High dose","Fraction","2023-06-20",{"date":231,"type":32},"2023-06-22",{"date":233,"type":20},"2023-06",{"date":235,"type":20},"2028-06",{"name":237,"class":39},"Peking University Third Hospital",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":48,"minAge":245,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":21,"phases":248,"briefSummary":250,"conditions":251,"keywords":255,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":40},"100461260","phase-1-phase-ibii-trial-of-combining-pembrolizumab-and-lenvatinib-with-sbrt-for-hcc-patients-with-portal-vein-thrombosis-100461260","NCT05286320","Phase Ib\u002FII Trial of Combining Pembrolizumab and Lenvatinib With SBRT for HCC Patients With Portal Vein Thrombosis.","Phase Ib\u002FII Trial of Combining Pembrolizumab and Lenvatinib With Stereotactic Body Radiotherapy for Hepatocellular Carcinoma Patients With Portal Vein Thrombosis.","Inclusion Criteria:\n\n1. Male\u002Ffemale participants who are at least 20 years of age on the day of signing informed consent with histologically confirmed diagnosis of HCC or those diagnosed by the EASL non-invasive criteria for HCC will be enrolled in this study.\n2. Male participants:\n\n   A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 220 days after the last dose of study treatment and refrain from donating sperm during this period.\n3. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR\n   2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 150 days after the last dose of study treatment.\n4. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n5. Have measurable disease based on mRECIST.\n6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n7. Have adequate organ function as defined in the following criteria (Specimens must be collected within 10 days prior to the start of study intervention) :(1)Absolute neutrophil count (ANC) ≥1500\u002FµL. (2)Platelets ≥100000\u002FµL. (3)Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL. (4)Creatinine OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN. (5)Total bilirubin ≤1.5 ×ULN (mg\u002FdL) OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>2.5 × ULN (mg\u002FdL).(6)AST (SGOT) and ALT (SGPT) ≤5 × ULN. (7)Alkaline phosphatase ≤2 × ULN.(8)Child-Pugh class Class A. (9)International normalized ratio (INR) OR prothrombin time (PT)、Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.\n8. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to starting study intervention. Participants with HBV will be eligible as long as they meet the following criteria: (1) Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to starting study intervention. (2)Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n9. Patients have PVTT in the main trunk (VP4) or central branch (VP3).\n10. Previous liver resection, embolization, or ablative therapy is permitted.\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to \\[allocation\\]. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n3. Has received prior systemic anti-HCC therapy including investigational agents or other local therapy within 4 weeks prior to \\[allocation\\].\n4. Has received prior radiotherapy to non-liver sites within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n5. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive or modulation therapy within 7 days prior to the first dose of study drug.\n7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n8. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n9. Has severe hypersensitivity (≥Grade 3) to pembrolizumab\u002FLenvatinib and\u002For any of their excipients.\n10. 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 and is allowed.\n11. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n12. Has an active infection requiring systemic therapy.\n13. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n15. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n16. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n17. Has had an allogenic tissue\u002Fsolid organ transplant.\n18. Child-Pugh class B or C cirrhosis of liver.\n19. Patients with a history of selective internal radiation therapy (eg, microsphere radioembolization) or who have received radiotherapy to the abdominal area prior to the initiation of study treatment.\n20. Patients who have an inadequate hepatic reserve, as judged by the investigator; ie, normal liver tissue volume \\\u003C700 mL.\n21. Patients who fail to follow the radiation dose constraint of any critical organ.\n22. Has a preexisting Grade ≥3 gastrointestinal or non-gastrointestinal fistula.\n23. Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior to the first dose of study intervention.\n24. Has significant cardiovascular impairment within 12 months prior to the first dose of study intervention such as history of congestive heart failure greater than NYHA Class II, unstable angina, myocardial infarction or cerebrovascular accident stroke, or cardiac arrhythmia associated with hemodynamic instability.\n25. Has had major surgery to the liver within 4 weeks prior to the first dose of study intervention.\n\n    Note: f participant underwent major surgery, they must have adequately recovered from the toxicity and\u002For complications from the intervention prior to starting study intervention.\n26. Has had a minor surgery (ie, simple excision) within 7 days prior to the first dose of study intervention (Cycle 1 Day 1).\n27. Has serious nonhealing wound, ulcer, or bone fracture.\n28. Participants with proteinuria \\>1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥1 g\u002F24 hours will be ineligible.\n29. Has prolongation of corrected QT (QTc) interval to \\>480 ms (corrected by Fridericia Formula) or is taking drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics (Quinidine, Procainamide, Disopyramide, Amiodarone, Sotalol, Ibutilide, Dofetilide \\& Dronedarone).\n30. Has LVEF below the institutional normal range as determined by MUGA or echocardiogram (ECHO).\n31. Has dual active HBV infection (HbsAg positive and \u002For detectable HBV DNA) and HCV infection (anti-HCV Ab positive and detectable HCV RNA) at study entry.\n32. Uncontrolled blood pressure \\> 140\u002F90 mmHg in spite of an optimal regimen of antihypertensive medication.","20 Years",{"count":247,"type":20},27,[249,140],"PHASE1","HCC patients with PVTT (main trunk or the first-degree branch) treated with the combination of pembrolizumab (Ketruda), lenvatinib (Lenvima), and SBRT.",[252,253,254,27],"Unresectable Hepatocellular Carcinoma","Pembrolizumab","Lenvatinib",[252,256,87,257],"Immunotherapy","targeted therapy","2023-02-28",{"date":260,"type":32},"2023-03-02",{"date":262,"type":20},"2023-03-01",{"date":264,"type":20},"2026-09-30",{"name":266,"class":39},"National Taiwan University Hospital"]