[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dtc---differentiated-thyroid-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dtc---differentiated-thyroid-cancer":26},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100615064","phase-1-a-phase-i-trial-of-af-001-in-patients-with-differentiated-thyroid-cancer-100615064",false,"NCT07287748","A Phase I Trial of Af-001 in Patients With Differentiated Thyroid Cancer","A Phase I Trial of the Alpha Particle-emitting Radiopharmaceutical, Af-001, in Patients With Differentiated Thyroid Cancer","Inclusion Criteria:\n\n\\\u003CIa part\\>\n\n* Patients with differentiated thyroid cancer (papillary carcinoma, follicular carcinoma) after total thyroidectomy.\n* Patients with radically unresectable, recurrent, metastatic disease who are judged by the principal investigator or sub-investigator (hereinafter, \"principal\u002Fsub-investigators\") to be refractory to or intolerant of standard-of-care therapy.\n\n\\\u003CIb part\\>\n\n* Patients with radically unresectable, recurrent, metastatic disease who are RAI naive\n* Patients with measurable lesions. \\\u003CIa\u002FIb part\\>\n* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 and stable general condition.\n* Patients expected to survive for at least 6 additional months based on clinical symptoms and physical examination findings.\n\nExclusion Criteria:\n\n\\\u003CIa\u002FIb part\\>\n\n* Patients who need to preserve fertility.\n* Females who are pregnant or may be pregnant, breastfeeding patients, or patients or their partners who cannot agree to appropriate contraception.\n* Patients with active multiple cancers (synchronous multiple cancers and ectopic double cancers with a disease-free period of \\\u003C=3 years).\n* Patients with uncontrolled active infections.\n* Patients who are positive for hepatitis B virus surface (HBs) antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies.","ALL","18 Years",{"count":19,"type":20},38,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This trial consists of 2 parts, i.e., Part Ia and Ib. The Part Ia is to evaluate the safety and tolerability of a single intravenous dose of af-001 in patients with radically unresectable, recurrent, metastatic differentiated thyroid cancer (papillary carcinoma, follicular carcinoma) refractory to or intolerant of standard-of-care therapy, who have received total thyroidectomy, and to determine the MTD (Maximum tolerated dose).\n\nPart Ib is to evaluate the efficacy and safety of af-001 mutiple doses to patients with radically unresectable, recurrent, metastatic differentiated thyroid cancer (papillary carcinoma, follicular carcinoma), who have received total thyroidectomy and are RAI naïve, randomized into two arms at the determined MTD or the MTD-1 dose level, and to determine the recommended Phase II dose (RP2D)",[26],"DTC - Differentiated Thyroid Cancer",[28,29,30],"DTC","At211","alpha particle-emitting radiopharmaceutical","RECRUITING","2025-12-25",{"date":34,"type":35},"2025-12-31","ACTUAL",{"date":37,"type":20},"2026-01-01",{"date":39,"type":20},"2028-07-31",{"name":41,"class":42},"Alpha Fusion Inc.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100547226","recombinant-human-thyroid-stimulating-hormone-for-radioiodine-131i-treatment-100547226","NCT06405217","Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment","Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment in Patients With Locally Advanced\u002FMetastatic Differentiated Thyroid Cancer","Inclusion Criteria:\n\n* Age: 18\\~75 years old (including 18 and 75 years old);\n* ECOG: 0-2 points;\n* Expected survival of more than 3 months; Differentiated thyroid carcinoma undergoing total thyroidectomy or subtotal thyroidectomy and confirmed as locally recurrent or metastatic disease by imaging, serum tumor marker, biopsy pathology; at least one measurable lesion (diameter of the tumor ≥10 mm), and meets the requirements of RECIST 1.1.\n* Hemoglobin ≥80g\u002FL, neutrophil ≥1.5×109\u002FL, platelet count ≥80×109\u002FL, serum creatinine ≤1.5× upper limit of normal or creatinine clearance ≥60ml\u002Fmin, Blood urea nitrogen ≤2.5× upper limit of normal (ULN); Total bilirubin ≤1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST≤5×ULN albumin ≥25 g\u002FL;\n* Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 1 year after the last dose of 131I (for women), or for 6 months after the last dose of 131I (for men);\n* Participants voluntarily joined the study and signed informed consent, with good compliance and follow-up.\n\nExclusion Criteria:\n\n* Patients with severe and uncontrolled diseases, including: 1) Uncontrolled hypertension (despite optimal drug therapy, systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg); 2) Poorly controlled arrhythmias of ischemic heart disease or myocardial infarction of grade II or above (including corrected QT interval male ≥450 ms, female ≥470 ms) and ≥2 congestive heart failures (New York Heart Association classification); 3) Poorly controlled diabetes (fasting blood sugar \\>10mmol\u002FL); 4) Active or poorly controlled severe infections (according to Common Terminology Criteria for Adverse Events ≥ grade 2); 5) Patients with active hepatitis B or hepatitis C (hepatitis B: positive HBsAg and hepatitis B virus (HBV) DNA ≥500 IU\u002FmL; hepatitis C: positive hepatitis C virus RNA and abnormal liver function), or active infections requiring antimicrobial therapy (e.g., with antibiotics, antiviral drugs, antifungal drugs); 6) Renal insufficiency: urine routine shows urine protein ≥++ or confirmed 24-hour urine protein ≥1.0 g; 7) Patients with seizures requiring treatment.\n* Received surgical treatment, incisional biopsy, or major trauma within 28 days prior to randomization;\n* Unable to quit or with a history of psychiatric medication abuse;\n* Allergic to the investigational drug (recombinant human thyroid stimulating hormone or 131I) or its excipients;\n* Had an infection within 4 weeks prior to screening, including bacterial, viral, or fungal infections, with ongoing symptoms at the time of screening;\n* Received lipophilic iodine contrast agents (such as iodized oil, iodized benzene, etc.) within the past 3 months or received water-soluble iodine contrast agents (such as iohexol, iodinated glycerol, etc.) within the past 1 month prior to screening;\n* Pregnant or lactating women, or women who engaged in unprotected sexual intercourse within the two weeks prior to screening, or women with a positive blood pregnancy test at screening;\n* Male subjects (or their partners) or female subjects who have plans for fertility or donation of sperm or ova during the entire study period and within 6 months after the end of the study, and who are unwilling to adopt contraceptive measures during the study period and within 6 months after the end of the study;\n* Researchers believe that the presence of any condition may harm the subjects or prevent them from meeting or fulfilling the study requirements.","75 Years",{"count":53,"type":20},30,[55],"NA","Subjects: patients with postoperative local recurrent or metastatic differentiated thyroid cancer .\n\nExperimental group: Recombinant human thyroid stimulating hormone injection: 0.9mg\u002F1.0mL\u002Fpiece; intramuscular injection; once a day for two consecutive days. Control group: Thyroid hormone withdraw for 4-6 weeks.\n\nThe two groups were treated with radioiodine 131I after plasma thyroid stimulating hormone elevated (\\>30mU\u002FL). The efficacy and adverse reactions were observed.",[26,58,59],"Thyroid Stimulating; Hormone, C","Radiotherapy; Complications","2024-05-03",{"date":62,"type":35},"2024-05-08",{"date":64,"type":35},"2024-04-20",{"date":66,"type":20},"2026-12-31",{"name":68,"class":69},"Nanjing First Hospital, Nanjing Medical University","OTHER"]