[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bladder-urothelial-transitional-cell-cancer-metastatic-or-unresectable\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bladder-urothelial-transitional-cell-cancer-metastatic-or-unresectable":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100583778","phase-2-177lu-fap-2286-treatment-in-urethelial-neoplasms-utility-and-safety-as-a-novel-treatment-100583778",false,"NCT06880757","177Lu-FAP-2286 Treatment in Urethelial Neoplasms: Utility and Safety as a Novel Treatment.","FAUNUS","Inclusion Criteria:\n\n* Patients with histopathologically proven advanced stage urothelial bladder cancer refractory to all standard therapies and no standard treatments are available or are contraindicated.\n\n  * Patients aged \\>18y, male or female gender\n  * Patients who are willing to cooperate with the study protocol, including the therapy regimen, posttherapy imaging and follow up visits\n  * Patients who read and signed the written informed consent form.\n  * A positive Ga-68-FAPI scan result (at least 50% of the lesions with an SUVmax \\>1.5 times liver SUVmax )\n  * Blood tests (Platelets\\>120.000\u002Fmm3, Neutrophils\\>1500cell\u002Fmm3, Hb\\>8g\u002FdL\n  * Liver function tests: (ALT and AST\\\u003C2.5Xupper limit of normal, Bilirubin\\\u003C2mg\u002FdL, Total bilirubin\\\u003C1.5X upper limit of normal\n  * PT, aPTT and INR in normal range\n  * Normal GFR, serum Cr levels\n  * ECOG 0-1\n  * Life expectancy longer than 6 months\n\nExclusion Criteria:\n\n* Low Ga-68-FAPI uptake\n* Not willing to sign informed consent form\n* ECOG \\>1\n* Hematological tests and renal function tests are not eligible\n* Disseminated bone marrow metastasis\n* Central nervous system metastasis or existence of any lesion with risk of compression\n* Co-existing secondary malignancies\n* Previous radioligand therapies\n* Being received anticancer therapies in 4 weeks","ALL","18 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Ga-68-FAPI has recently been proven to be superior to F-18-FDG in various cancers. These results have also raised hope in using FAP radiopharmaceuticals with theranostic approach. Lu-177 bound FAPI molecules have been started to be used in some cancers in clinical trials following its efficacy proven by case reports. Similarly,as a pilot study, this project aims to investigate safety and efficacy of Lu-177- FAP-2286 in metastatic urothelial carcinomas of bladder.\n\nA total of 10 histopathologically proven urothelial bladder cancer patients \\>18y of age will be included in the study. After taking informed consent, all patients will undergo both 18F-FDG PET\u002FCT and 68Ga-FAPI PET\u002FCT for restaging before initiation of Lu-177-FAP-2286. Patients who show progression despite advanced therapies and high Ga-68 FAPI uptake will be enrolled. Patients with histopathologically proven advanced stage urothelial bladder cancer refractory to all standard therapies and no standard treatments are available or are contraindicated. Radiopharmaceutical will be administered 150mCi fixed dose, 3 cycles, 8 weeks interval. Posttherapy whole body SPECT\u002FCT imaging will be obtained 4.,24.,96,120Hours of treatment for dosimetric calculations. All patients will be monitored for safety issues and possible long term side effects. Hematological tests, renal and liver function tests will be performed every 2 weeks, radiological imaging for tumor response assessment will be performed every 6 weeks. Symptoms will be taken under consideration for symptomatic response QoL questioner. In case of objective progression, therapy will be stopped. Otherwise, will be completed to 4 cycles.\n\nAdministration of Lu-177 FAPİ treatment will be performed by 1st partner from Turkey. Posttreatment SPECT\u002FCT images will be obtained and collected for dosimetric calculations. Heatly organ doses and tumor doses will be calculated bt 2nd partner form Italy in collaboration with 1st partner. In consideration of the advances in radionuclide treatments to achieve objective response within safety margins to healthy organs, dosimetric approaches are mandatory. As a novel treatment dosimetric data for Lu-177 FAPİ treatment is limited. Despite to being a reference center for radionuclide treatments 1st partner has no experience on dosimetric calculations for systemic radionuclide treatments. As an experienced center for dosimetric studies, 2nd partner will be a milestone for analysis of dose response and toxicity analyses for this pilot study of novel treatment.",[26],"Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable",[28,29,30],"Bladder Cancer","Radionuclide treatment","Dosimetry","NOT_YET_RECRUITING","2025-03-12",{"date":34,"type":35},"2025-03-18","ACTUAL",{"date":37,"type":20},"2025-06-01",{"date":39,"type":20},"2028-06-01",{"name":41,"class":42},"Ankara University","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100579127","phase-4-ddr-genes-alteration-and-response-to-platinum-based-chemotherapy-in-advanced-urothelial-cancer-100579127","NCT06820255","DDR Genes Alteration and Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer.","Prospective Evaluation of the DDR Genes Alteration to Predict Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer.","SELECTIO-UC","Inclusion Criteria:\n\n1. Informed consent obtained before any study-specific procedures. Patients must be able to understand and be willing to sign a written informed consent.\n2. Male or female patient ≥18 years of age.\n3. Histological or cytological documentation of urothelial cancer.\n4. Available tumor tissue for analysis\n5. Measurable disease according to Response Evaluation Criteria in Solid Tumors criteria, version 1.1.\n6. Eastern Cooperative Oncology Group performance status of ≤2. (Patients with ECOG PS of 2 were required to also meet the additional criteria: hemoglobin ≥10 g\u002FdL, GFR ≥50mL\u002Fmin, may not have NYHA class III heart failure).\n7. Life expectancy of at least 6 months.\n8. Eligible to standard chemotherapy with cisplatin or carboplatin + gemcitabine as per clinical practice.\n9. Women of childbearing potential and men must agree to use adequate contraception since signing of the informed consent form until 180 days after the last dose of chemotherapy and 30 days after the last dose of avelumab. The investigator or a designated associate is requested to advise the subject how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommend method (or combination of methods) as per standard of care.\n10. Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:\n\na Creatinine value \\\u003C2.5 mg\u002Fdl and creatinine clearance \\> 30 ml\u002Fmin evaluated by the Cockcroft-Gault Formula.\n\nb Total bilirubin ≤1∙5 × the upper limit of normal (ULN); c Alanine aminotransferase and aspartate aminotransferase ≤2 × ULN (≤5 × ULN for patients with liver involvement of their cancer); d International normalized ratio (INR) and partial thromboplastin time (PTT) ≤1∙5 × ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence of an underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care; e Platelet count ≥100 000\u002Fmm3, hemoglobin \\>9 g\u002Fdl, absolute neutrophil count \\>1,500\u002Fmm3; f Alkaline phosphatase limit ≤2∙5 × ULN (≤5 × ULN for patients with liver involvement of their cancer).\n\nExclusion Criteria:\n\n1. Previous treatment for metastatic or locally advanced disease.\n2. Previous adjuvant therapy within 1 year from the diagnosis of metastatic disease.\n3. Prior treatment with immunotherapy.\n4. Previous or concurrent cancer that is distinct in primary site or histology from urothelial cancer within 3 years before enrollment EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors (Ta \\[non-invasive tumor\\], Tis \\[carcinoma in situ\\], and T1 \\[tumor invades lamina propria\\]), pT2 prostate cancer with PSA\\\u003C0.01.\n5. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication\n6. Pregnancy or breast-feeding. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment.\n7. Any cardiological condition among:\n\n   1. Congestive heart failure of New York Heart Association class 3 or worse.\n   2. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study drug.\n   3. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted).\n   4. Uncontrolled hypertension (systolic blood pressure \\>150 mmHg or diastolic pressure \\>90 mmHg despite optimal medical management).\n   5. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), pulmonary embolism within the 4 months before start of study medication.\n8. Ongoing infection higher than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 grade 2.\n9. Known history of human immunodeficiency (HIV) virus infection or known history of chronic hepatitis B or C.\n10. Any autoimmune disease that contraindicates the use of maintenance immunotherapy in case of stable or responsive disease to chemotherapy.\n11. Seizure disorder requiring medication.\n12. Symptomatic metastatic brain or meningeal tumors unless the patient is \\>2 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also, the patient must not be undergoing acute steroid therapy or tapering (chronic steroid therapy is acceptable provided that the dose is stable for 1 month before and after screening radiographic studies).\n13. History of organ allograft.\n14. Evidence or history of bleeding diathesis. Any hemorrhage or bleeding event of CTCAE grade 3 or higher within 4 weeks of start of study medication.\n15. Non-healing wound, ulcer, or bone fracture.\n16. Renal failure requiring hemodialysis or peritoneal dialysis.\n17. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his or her compliance in the study.\n18. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n19. Participation to another clinical trial at the time of the enrollment.",{"count":52,"type":20},135,[54],"PHASE4","This study aims to prospectively observe whether certain alterations in some genes related to the DNA repair mechanism are related to better response to platinum-based chemotherapy used to treat metastatic bladder or urothelial cancers.",[26,57],"Upper Tract Urothelial Cancer",[59,60,61],"DNA damage response genes","cisplatin","carboplatin","RECRUITING","2025-02-06",{"date":65,"type":35},"2025-02-11",{"date":67,"type":35},"2025-01-07",{"date":69,"type":20},"2027-01-07",{"name":71,"class":42},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",1]