[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urogenital-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urogenital-diseases":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":39,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100568077","vorolanib-in-the-second-line-treatment-of-patients-with-unresectable-or-metastatic-renal-cell-carcinoma-100568077",false,"NCT06676527","Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma","An Observational Study of the Efficacy and Safety of Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma","Inclusion Criteria:\n\n* Subjects have fully understood and voluntarily signed the informed consent form (ICF);\n* 18-80 years old (at the time of signing the informed consent); Both men and women; ECOG PS score: 0-1;\n* Renal cell carcinoma with clear cell components confirmed histologically or cytopathologically, including unresectable or recurrent metastatic renal cell carcinoma dominated by clear cell components;\n* According to RECIST (version 1.1), there are targets that are considered to be observable;\n* The main organs function well.\n\nExclusion Criteria:\n\n* A history of malignancies other than the disease studied within the past 5 years, other than malignancies that are expected to be cured with treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery);\n* Systemic treatment with other antitumor agents, including targeted agents, immunotherapy agents and their combination regimens (eligible for inclusion after 5 half-lives), local antitumor therapy, or clinical investigational drug or device therapy within 4 weeks prior to the initial study;\n* Had major surgery within 4 weeks prior to initial study dosing (as judged by the investigator) or was in recovery;\n* A history of severe drug allergy, including but not limited to antibody drugs;\n* Patients with contraindications for immunotherapy restart;\n* A known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation may require long-term adrenal corticosteroid therapy. Patients with thyroid, suprarenal, or hypopituitarism that can be controlled by hormone replacement therapy alone, type 1 diabetes mellitus, and psoriasis or vitiligo that do not require systemic treatment are eligible to participate in this study;\n* Toxicity did not resolve after previous antitumor therapy, i.e., regression to baseline, NCI-CTCAE 5.0 level 0-1 (except for alopecia), or levels specified in inclusion\u002Fexclusion criteria. Irreversible toxicity (e.g., hearing loss) that is not reasonably expected to be aggravated by the drug under study may be included in the study;\n* Have central nervous system metastases and\u002For cancerous meningitis;\n* Known history of clinically significant liver disease, including those infected with viral hepatitis activity;\n* Patients with uncontrolled third space effusion requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (Patients with no need to drain effusion or no significant increase in effusion after 3 days of stopping drainage could be included);\n* Patients with any severe and\u002For uncontrolled disease;\n* Renal failure requires hemodialysis or peritoneal dialysis;\n* Have or have a suspected active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.;\n* History of live attenuated vaccine vaccination within 4 weeks prior to the initial study or expected live attenuated vaccine vaccination during the study period;\n* Those who have a history of psychotropic drug abuse and cannot abstain or have a history of mental disorders;\n* Other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities, as determined by the investigator, that may increase the risks associated with study participation or that may interfere with the interpretation of the study results.","ALL","18 Years","80 Years",{"count":20,"type":21},39,"ESTIMATED","12 Weeks","OBSERVATIONAL","This is a multicenter real world study (RWS) initiated by the investigator. Eligible patients will be selected for treatment with second-line treatment including vorolanib and followed up. The real survival data of patients after medication will be collected and compared with the data of CONCEPT study, and multi-factor stratified analysis of the efficacy of voronib will be conducted.",[26,27,28,29,30,31,32,33,34,35,36,37,38],"Neoplasms","Kidney Neoplasms","Urologic Neoplasms","Urogenital Neoplasms","Female Urogenital Diseases","Male Urogenital Diseases","Urogenital Diseases","Kidney Diseases","Urologic Diseases","Carcinoma","Renal Cell Cancer","Carcinoma, Renal Cell","Antineoplastic Agents",[40,41,42],"observational study","clear cell Renal Cell Carcinoma","TKIs","RECRUITING","2025-12-04",{"date":46,"type":47},"2025-12-05","ACTUAL",{"date":49,"type":47},"2024-09-01",{"date":51,"type":21},"2026-09-01",{"name":53,"class":54},"Jinling Hospital, China","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":76,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100534368","phase-2-stage-ii-iiia-urothelial-cancer-randomizing-pre-operative-nivolumab-with-or-without-relatlimab-100534368","NCT06237920","Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab","A Phase 2 Trial in Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab","TURANDORELA","Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Age ≥ 18 years\n* Resectable muscle-invasive UC of the bladder, defined as cT2-4aN0M0 OR cT1-4aN1M0. In cT1N1 patients, lymph node positivity would need to be cytologically or histologically confirmed.\n* Surgical resection (cystectomy) is the advised locoregional treatment and is accepted by the subject after consultation with the urologist.\n* Patients are either cisplatin ineligible or elect to not undergo cisplatin based neoadjuvant chemotherapy after a balanced discussion of risks and benefits with the treating physician. Cisplatin eligibility is determined based on the Galsky criteria\n* World Health Organization (WHO) performance Status 0 or 1.\n* Urothelial cancer is the dominant histology (\\>50%). Any component of small cell or adenocarcinoma is not allowed.\n* Formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks from diagnostic TUR available.\n* Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109\u002FL, Platelets ≥100 x109\u002FL, Hemoglobin ≥5.5 mmol\u002FL, GFR\\>30 ml\u002Fmin, AST ≤ 1.5 x ULN, ALT ≤1.5 x ULN, Bilirubin ≤1.5 X ULN\n* Negative pregnancy test (βHCG in blood or urine) within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential.\n* Highly effective contraception for female subjects if the risk of conception exists. Female patients of childbearing potential must comply with contraception methods as requested by the study protocol (→ 8.2.1 Pregnancy, contraception and breastfeeding)\n\nExclusion Criteria:\n\n* Subjects with active autoimmune disease in the past 2 years. Patients with diabetes mellitus, properly controlled hypothyroidism or hyperthyroidism, vitiligo, psoriasis or other mild skin disease can still be included.\n* Documented history of severe autoimmune disease (e.g. inflammatory bowel disease, myasthenia gravis).\n* Previous intravenous systemic therapy or radiotherapy for UC.\n* Upper urinary tract disease, unless all disease is planned to be resected in the same surgery as for UBC. This includes non-muscle-invasive disease.\n* Prior CTLA-4, LAG3 or PD-1\u002FPD-L1-targeting immunotherapy.\n* Known active Human Immunodeficiency Virus infection, or tuberculosis, or other active infection:\n* HIV-positive patients are eligible if the following applies:\n* No AIDS defining opportunistic infection within the last year and a current CD4 count \\>350 cells\u002FuL.\n* Received antiretroviral therapy (ART) for at least 4 weeks prior to treatment and continued while enrolled on study\n* CD4 counts and viral load are monitored per standard of care by a local health care provider\n* In patients with a known history of hepatitis B or hepatitis C infection, Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA) should be negative\n* Underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples may include severe pulmonary disease with extensive radiological abnormalities or intestinal disease causing severe diarrhea, not covered by other eligibility criteria, that may obscure colitis.\n* Medical condition requiring the use of immunosuppressive medications, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) will be allowed.\n* Use of other investigational drugs before study drug administration.\n* Malignancy, other than urothelial cancer, in the previous 2 years, with a high chance of recurrence (estimated \\>10%). Patients with low-risk prostate cancer (defined as Stage T1\u002FT2a, Gleason score ≤ 6, and PSA ≤ 10 ng\u002FmL) who are treatment-naive and undergoing active surveillance are eligible.\n* Pregnant and lactating female patients.\n* Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.\n* Severe infections within 2 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to enrolment, unstable arrhythmias and unstable angina.",{"count":65,"type":21},90,"INTERVENTIONAL",[68],"PHASE2","This is a non-blinded phase 2 trial in Stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab to assess whether bladder preservation after dual immunotherapy would be a viable treatment option for patients responding to treatment",[28,29,71,26,30,72,32,73,31,74,75],"Neoplasms by Site","Female Urogenital Diseases and Pregnancy Complications","Urinary Bladder Diseases","Urinary Bladder Neoplasm","Antineoplastics Toxicity",[77,78],"Nivolumab","Relatlimab","2025-09-01",{"date":81,"type":47},"2025-09-03",{"date":83,"type":47},"2024-02-19",{"date":85,"type":21},"2028-08-01",{"name":87,"class":54},"The Netherlands Cancer Institute",9]