[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"proton-radiotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:proton-radiotherapy":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100592919","phase-2-proton-radiotherapy-plus-tremelimumabdurvalumab-for-bclc-stage-b-and-c-hcc-100592919",false,"NCT06999694","Proton Radiotherapy Plus Tremelimumab\u002FDurvalumab for BCLC Stage B and C HCC","Proton Radiotherapy Combined With Tremelimumab and Durvalumab for BCLC Stage B and C Hepatocellular Carcinoma","Proton-STRIDE","Inclusion Criteria:\n\n1. Participants must have diagnosis of HCC that is deemed unsuitable for surgical resection or transplant. Participants may have multiple lesions with a total maximal tumor dimension of \\\u003C 20 cm, and no one lesion \\> 15 cm. Diagnosis should be confirmed by at least 1 criterion listed below:\n\n   * Histologically or cytologically proven diagnosis of HCC.\n   * Typical arterial enhancement and delayed washout on multiphasic CT or MRI.\n2. Age ≥18 years at the time of signing informed consent document.\n3. ECOG performance status 0-1.\n4. Barcelona Clinic Liver Cancer (BCLC) stages Intermediate (B) or Advanced (C).\n5. Child-Pugh score 5-6 liver function within 28 days of study registration.\n6. Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test.\n7. Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test.\n8. Ability to understand and the willingness to sign a written informed consent document\n9. Adequate bone marrow, liver, and renal function within 4 weeks before study registration\n\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm3\n   * Platelet count ≥ 50,000\u002FμL\n   * Total bilirubin \\\u003C 2.5 mg\u002FdL\n   * Serum albumin \\>2.8 g\u002FdL\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN)\n   * Prothrombin time ≤ 6 seconds prolonged\n   * Serum creatinine ≤ 1.5 mg\u002FdL\n\nExclusion Criteria:\n\n1. Prior invasive malignancy unless disease free for a minimum of 2 years\n2. Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields\n3. Prior selective internal radiotherapy\u002Fhepatic arterial yttrium therapy, at any time\n4. Untreated active hepatitis B or hepatitis C\n5. Moderate to severe or intractable ascites\n6. Presence of distant metastases that cannot be encompassed by proton radiotherapy\n7. Untreated or incomplete treated esophageal or gastric varices\n8. Severe, active co-morbidity, defined as follows:\n\n   * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months prior to registration\n   * Myocardial infarction within the last 6 months prior to study entry\n   * Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry\n   * A bleeding episode within 6 months prior to study entry due to any cause.\n   * Thrombolytic therapy within 28 days prior to study entry.\n   * Known bleeding or clotting disorder.\n   * Uncontrolled psychotic disorder\n9. Pregnancy or women of childbearing potential and men who are sexually active and not willing\u002Fable to use medically acceptable forms of contraception\n10. Prior solid organ transplantation.\n11. Prior or active autoimmune disease (AID) including autoimmune hepatitis, inflammatory bowel disease, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, and multiple sclerosis.\n12. Prior or active thrombotic or bleeding disorders, hemoptysis, cerebral vascular accident, significant cardiac disease (ischemic or congestive heart failure), or gastrointestinal perforation.\n13. Inability to treat all sites of disease by proton radiotherapy (such as extrahepatic metastases or massive liver tumors whereby the liver constraints cannot be met for covering all sites of liver tumors using proton radiotherapy.)\n14. Known HIV infection.","ALL","18 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Tremelimumab plus durvalumab (STRIDE regimen) is an approved first-line therapy for unresectable hepatocellular carcinoma (HCC), yet it shows limited efficacy with an ORR of only 20.1%. Proton radiotherapy (RT), known for its precision and tissue-sparing advantages, has demonstrated improved survival outcomes and reduced toxicity compared to X-ray RT. Retrospective data suggest that combining proton RT with immune checkpoint inhibitors yields a promising ORR of 61.5%. Preclinical studies further support enhanced antitumor immunity when RT is combined with PD-L1 and CTLA-4 blockade. This phase II, single-arm clinical trial aims to evaluate the safety, efficacy, and immunologic effects of combining proton RT with tremelimumab and durvalumab in patients with unresectable HCC.",[27,28,29,30],"HCC - Hepatocellular Carcinoma","Durvalumab","Tremelimumab","Proton Radiotherapy","RECRUITING","2025-09-03",{"date":34,"type":35},"2025-09-10","ACTUAL",{"date":37,"type":35},"2025-05-22",{"date":39,"type":21},"2033-05-31",{"name":41,"class":42},"Chang Gung Memorial Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100540063","phase-2-the-clinical-study-of-post-operative-proton-radiotherapy-for-thymus-tumor-100540063","NCT06311968","The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor","Prospective Phase II Clinical Study of R0\u002FR1 Post-operative Proton Radiation Therapy for Thymus Epithelial Malignancies","Inclusion Criteria:\n\n* Patients with stage II-III (Masaoka-Koga) thymus epithelial malignancies without a history of thoracic radiation therapy, who have undergone radical surgery and have a definite pathological diagnosis, and undergone surgery for R0 (no microscopic residual disease) or R1 (microscopic residual disease) resection, and have indication of postoperative radiation therapy.\n* Sign informed consent.\n* Between the ages of 18 and 70.\n* ECOG general status score of 0-2.\n* The expected survival is at least 6 months.\n* Adequate organ function: 1). Blood function: absolute neutrophil count (ANC) ≥1.5 x 109\u002FL, platelet count ≥80 x 109\u002FL, hemoglobin ≥9 g\u002FdL 2). Lung function: FEV1\\>25%, DLCO\\>25% 3). Cardiac function: no serious pulmonary hypertension, cardiovascular and cerebrovascular diseases, peripheral vascular diseases, serious chronic heart disease and other complications that may affect radiotherapy.4). Adequate liver function: total bilirubin \\\u003C1.5 times the upper limit of normal value, and AST, ALT\\\u003C2 times the upper limit of normal value. 5). Adequate renal function: serum creatinine ≤1.5 times the upper limit of normal or calculated creatinine clearance ≥50 ml \u002Fmin, and urinary protein \\\u003C2+. Patients with a baseline urinary protein level of 2+ or more should have a 24-hour urine collection and evidence of a 24-hour urinary protein level of 1g or less.\n\nExclusion Criteria:\n\n* Complicated with other malignant tumors that have not been controlled.\n* Have large quantity of pleural or pericardial effusion.\n* Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.\n* Chest radiation therapy or radioactive particle implantation history.\n* Cardiac pacemakers or other internal metal prosthesis implants that may be affected by high-energy radiation or may affect the dose distribution to the radiation target area.\n* HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral therapy. Active stage of syphilis.\n* A history of mental illness may hinder the completion of treatment.\n* With serious comorbidity that may interfere with radiotherapy, including: (a) Acute infectious diseases or acute active phase of chronic infection. b) Unstable angina pectoris, congestive heart failure, myocardial infarction that has been hospitalized in the past 6 months. c) Exacerbations of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization. d) Severely impaired immune function. e) Diseases with excessive sensitivity to radiation such as ataxia telangiectasia. f) Other diseases that may affect particle radiotherapy.\n* Other circumstances that the physician considers inappropriate to participate in clinical study.","70 Years",{"count":53,"type":21},55,[24],"To observe the efficacy and toxicities of post-operative (R0\u002FR1) proton radiotherapy for locally advanced primary thymus epithelial malignancies. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was overall survival and cause-specific survival.",[57,30,58],"Thymus Epithelial Tumor","Radiation Toxicity","2025-06-10",{"date":61,"type":35},"2025-06-13",{"date":63,"type":35},"2024-05-06",{"date":65,"type":21},"2027-02-28",{"name":67,"class":42},"Jian Chen"]