[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-renal-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-renal-cell":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,63,86,108,146,182,205,228,267,290,312,335,358],{"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":25,"conditions":26,"keywords":38,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100431255","phase-1-a-study-of-bms-986340-as-monotherapy-and-as-combination-therapy-in-participants-with-advanced-solid-tumors-100431255",false,"NCT04895709","A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria\n\n* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Radiographically documented progressive disease on or after the most recent therapy.\n* Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced\u002Fmetastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.\n* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.\n\nExclusion Criteria\n\n* Women who are pregnant or breastfeeding.\n* Primary central nervous system (CNS) malignancy.\n* Untreated CNS metastases.\n* Leptomeningeal metastases.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.\n* Active, known, or suspected autoimmune disease.\n* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.\n* Prior organ or tissue allograft.\n* Uncontrolled or significant cardiovascular disease.\n* Major surgery within 4 weeks of study drug administration.\n* History of or with active interstitial lung disease or pulmonary fibrosis.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},1109,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.",[27,28,29,30,31,32,33,34,35,36,37],"Cervical Cancer","Gastric\u002FGastroesophageal Junction Adenocarcinoma","Microsatellite Stable Colorectal Cancer","Non-Small-Cell Lung Cancer","Squamous Cell Carcinoma of Head and Neck","Carcinoma, Renal Cell","Urothelial Carcinoma","Pancreatic Adenocarcinoma","Melanoma","Ovarian Neoplasms","Triple Negative Breast Neoplasms",[39,27,40,41,42,28,43,29,44,45,30,46,47,31,32,33,34,35,36,37,48,49],"BMS-986340","CRC","First-in-human","GEJ","HNSCC","MSS CRC","Nivolumab","NSCLC","SCCHN","Docetaxel","Pumitamig","RECRUITING","2026-06-29",{"date":53,"type":54},"2026-06-30","ACTUAL",{"date":56,"type":54},"2021-05-27",{"date":58,"type":20},"2031-08-31",{"name":60,"class":61},"Bristol-Myers Squibb","INDUSTRY",47,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100630578","phase-3-a-clinical-study-of-belzutifan-mk-6482-and-zanzalintinib-in-people-with-renal-cell-carcinoma-rcc-litespark-034ls-034mk-6482-034-100630578","NCT07489495","A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034\u002FLS-034\u002FMK-6482-034)","A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants With Advanced RCC Who Have Progressed on or After Both PD-1\u002FL1 and VEGF-TKI Therapies in Sequence or in Combination (LITESPARK-034)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histologically confirmed diagnosis of unresectable, advanced renal cell carcinoma (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per American Joint Committee on Cancer (8th Edition)\n* Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)\n* Has received no more than 3 prior systemic regimens for RCC, including only 1 prior anti-Programmed Cell Death-1\u002FProgrammed Cell Death 1 Ligand 1 therapy\n\nExclusion Criteria:\n\nFor exclusion criteria: The main exclusion criteria include but are not limited to the following:\n\n* Has any of the following: a pulse oximeter reading \\\u003C92% at rest, requires intermittent supplemental oxygen, or required chronic supplemental oxygen\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention\n* Has deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization\n* Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram\n* Has had major surgery within 8 weeks before randomization\n* Has current pneumonitis\u002Finterstitial lung disease\n* Has a history of human immunodeficiency virus infection\n* Has Hepatitis B or Hepatitis C virus infection\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has a history of solid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications",{"count":71,"type":20},758,[73],"PHASE3","Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC).\n\nA standard (usual) treatment for certain people with RCC is belzutifan (a study medicine), which is a targeted therapy. Targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. Researchers want to learn if adding another targeted therapy called zanzalintinib (another study medicine) can treat more people with advanced RCC than belzutifan alone.\n\nThe goal of this study is to learn if people who receive belzutifan and zanzalintinib live longer overall and without the cancer getting worse compared to people who receive belzutifan and placebo.",[32],"2026-06-24",{"date":78,"type":54},"2026-06-26",{"date":80,"type":54},"2026-04-09",{"date":82,"type":20},"2030-11-27",{"name":84,"class":61},"Merck Sharp & Dohme LLC",41,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100624094","phase-3-extension-study-for-participants-in-studies-that-include-belzutifan-mk-6482-043litespark-043-100624094","NCT07405164","Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043\u002FLITESPARK-043)","A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long-term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Participants with advanced solid tumors or von Hippel-Lindau-related neoplasms who are participating in belzutifan-containing studies and on active treatment in a belzutifan parent study.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has an on-going serious adverse event in the parent study, unless no longer hospitalized and considered clinically stable.\n* Is currently on a dose interruption due to an Adverse Event (AE) in the parent study; once treatment has been resumed in the parent study, the participant is eligible to enroll.",{"count":94,"type":20},450,[73],"Researchers are looking for new ways to treat advanced solid tumors and von Hippel-Lindau (VHL)-related tumors:\n\n* Advanced means the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery\n* Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids\n* VHL-related tumors are tumors caused by VHL disease. VHL disease is passed down from parents to children and people with VHL disease have a higher chance of getting certain types of cancer\n\nResearchers want to learn about the long-term effects of a trial medicine called belzutifan. Belzutifan, also called MK-6482, is designed to block a protein that helps tumors grow and survive. This is an extension trial, which means only people who were in certain other belzutifan trials (called parent trials) may be able to join. The goal of this trial is to learn how long people live after they start taking belzutifan.",[98,32],"Von Hippel-Lindau Disease","2026-06-18",{"date":101,"type":54},"2026-06-23",{"date":103,"type":54},"2026-03-23",{"date":105,"type":20},"2034-01-14",{"name":84,"class":61},27,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":132,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"100610425","phase-1-symbiotic-gu-08-a-study-to-learn-about-the-medicine-called-pf-08634404-dosed-alone-and-in-combination-with-other-anticancer-therapies-in-adults-with-locally-advanced-or-metastatic-renal-cell-cancer-100610425","NCT07227415","Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer","AN INTERVENTIONAL PHASE 1B\u002F2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA","Inclusion Criteria:\n\n* 18 years of age or older at screening\n* Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology\u002Fcytology\n* At least one measurable (as defined by the investigator) and untreated lesion\n* Adequate hematologic, hepatic, cardiac and renal function\n* No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received \\>12 months prior)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories\n\nExclusion Criteria:\n\nParticipants may be excluded if they meet any of the following:\n\n* Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.\n* Clinically significant risk of haemorrhage or fistula\n* History of another malignancy within 3 years\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* active autoimmune diseases requiring systemic treatment within the past 2 years\n* uncontrolled cardiac and other comorbidities within 6 months prior to the first dose\n* Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study\n* History of severe bleeding tendency or coagulation dysfunction\n* History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months prior to the first dose\n* Acute, chronic or symptomatic infections\n* Participants with history of immunodeficiency",{"count":116,"type":20},224,[23,24],"This study is testing a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them.\n\nTo join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer.\n\nParticipants will receive study medicine either alone or with other anticancer medicines. The medicine will be given through intravenous (IV) infusions, which means it will be injected directly into a vein. All treatments will take place at clinical study sites, where trained medical staff will take care of participants during and after each visit.",[32,120,121,122,123,124,125,126,127,128,129,130,131],"Advanced Renal Cell Carcinoma","Renal Cancer","Renal Neoplasm","Clear Cell Renal Cell Carcinoma","Metastatic Renal Cell Carcinoma","Clear-cell Metastatic Renal Cell Carcinoma","Carcinoma, Renal Cell Metastasis","Advanced or Metastatic Renal Cell Carcinoma","Carcinoma, Renal Cell, Advanced","Metastatic Renal Cell Cancer","Metastatic Renal Cell Carcinoma ( mRCC)","Metastatic\u002FAdvanced Renal Cell Carcinoma",[133,134,135],"Renal cell carcinoma","renal cancer","renal neoplasm","2026-06-03",{"date":138,"type":54},"2026-06-04",{"date":140,"type":54},"2026-02-10",{"date":142,"type":20},"2028-11-01",{"name":144,"class":61},"Pfizer",109,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":155,"briefSummary":156,"conditions":157,"keywords":158,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100461384","phase-1-study-of-orellanine-in-metastatic-clear-cell-or-papillary-renal-cell-carcinoma-100461384","NCT05287945","Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma","A Phase I\u002FII, Open-Label, Single-Arm Study on Safety, Tolerability and Anti-Tumour Efficacy of Orellanine Treatment in Patients With Metastatic Clear-Cell or Papillary Renal Cell Carcinoma","Inclusion criteria:\n\n1. Has provided written informed consent.\n2. Has a diagnosis of histologically confirmed advanced ccRCC or pRCC. No conventional therapy is available or considered appropriate by the treating physician or is declined by the patient.\n3. For patients in the expansion portion of the study only: Measurable disease per RECIST version 1.1 criteria.\n4. ECOG performance status of 0 - 2.\n5. Age ≥18 years.\n6. Life expectancy ≥3 months.\n7. Has acceptable haematologic laboratory values defined as:\n\n   1. Neutrophils ≥1.5 × 10\\^9\u002FL, without growth factor stimulation within 3 weeks prior to the blood test;\n   2. Platelets ≥100 × 10\\^9\u002FL;\n   3. Haemoglobin ≥5.6 mmol\u002FL (\\~90 g\u002FL). Use of erythropoietin or blood transfusions are permitted.\n8. Has acceptable liver laboratory values defined as:\n\n   1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5 × ULN for patients with liver metastases\n   2. Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels \\>1.5 × ULN\n   3. For patients diagnosed with Gilbert's syndrome, total bilirubin ≤2 × ULN is acceptable.\n9. Must be on chronic hemodialysis (on a consistent regimen for the previous three months, with allowance for intermittent treatments as required for volume overload).\n10. The patient's treating nephrologist and oncologist agree that the prospect of loss of remaining renal function resulting from this treatment will not significantly change the patient's future and chronic dialysis treatment.\n11. Female patients of child-bearing potential and male patients must agree to use 2 forms of highly effective contraception for the duration of study treatment and after the last dose of orellanine for at least 3 months for males and 6 months for females.\n12. For females of child-bearing potential, a negative serum pregnancy test at screening.\n13. Patients who are willing and able to comply with travel requirements, scheduled visits, treatment schedule, efficacy assessments, laboratory tests, and other study procedures.\n\nExclusion criteria:\n\n1. Diagnosis of any other malignancy within 2 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, superficial melanoma, or carcinoma in situ of the breast or of the cervix, or low grade (Gleason 7 or below) prostate cancer on surveillance with no plans for treatment intervention (e.g., surgery, radiation, or castration)\n2. Radiotherapy within 2 weeks before first dose.\n3. Immuno-oncology therapy (IO) given in the last six (6) months prior to enrolment\n4. Other systemic anti-cancer therapy within 2 weeks before first dose.\n5. Has not recovered from AEs due to prior anti-cancer medications to at least grade 1 by CTCAE version 5.0 (except for alopecia and grade 2 neuropathy).\n6. Has received any other investigational product within 4 weeks before first dose.\n7. Pregnant or breastfeeding women.\n8. Uncontrolled medical condition including, but not limited to, ongoing or active infection or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, or would, in the opinion of the investigator, place the patient at increased risk.\n9. QTc interval at baseline of ≥470 msec.",{"count":154,"type":20},75,[23,24],"A phase I\u002FII, open-label, study to determine the safety and preliminary efficacy of orellanine in patients with metastatic clear-cell or papillary renal carcinoma who have failed standard-of-care therapy. All participants must have end-stage kidney disease and be receiving stable chronic hemodialysis.",[32],[159,160,161,162,163,164,165,166,167,168,169,170,171],"Renal cancer","Kidney cancer","Metastatic","Dialysis","Hemodialysis","Clear-cell renal cell carcinoma (ccRCC)","Metastatic renal cell carcinoma (mRCC)","Papillary renal cell carcinoma (pRCC)","End stage Kidney Disease","Advanced renal cell carcinoma","Investigational drug kidney cancer","ONC175","Oncorena","2026-05-20",{"date":174,"type":54},"2026-05-22",{"date":176,"type":54},"2023-08-04",{"date":178,"type":20},"2027-12-31",{"name":180,"class":61},"Oncorena AB",5,{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":21,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":204},"100533190","phase-1-study-to-evaluate-the-safety-and-efficacy-of-bicalutamide-in-combination-with-sunitinib-in-patients-with-tkis-resistant-rcc-100533190","NCT06222593","Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant RCC","A Phase I\u002FII Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With Receptor Tyrosine Kinase Inhibitor Resistant Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Be willing and able to provide written informed consent for the trial.\n2. Be greater than or equal to 18 years of age on day of signing informed consent.\n3. Have measurable disease based on RECIST 1.1\n4. Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale\n5. Demonstrate adequate organ function\n6. Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.\n7. Subjects of childbearing potential should be willing to use 2 methods of contraception for the course of the study through 120 days after the last dose of study medication\n8. Male subjects without a previous vasectomy should agree to use an adequate method of contraception (i.e. abstinence, condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream) starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n9. Subjects have archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment.\n10. Subjects must have a life expectancy of at least 6 months.\n\nExclusion Criteria:\n\n1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n3. Has active Bacillus tuberculosis (TB)\n4. Has a 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.\n5. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n6. Has an active infection requiring systemic therapy.\n7. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n8. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n9. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n10. Has a known history of Human Immunodeficiency Virus (HIV)\n11. Has known active Hepatitis B or Hepatitis C\n12. Has received a live vaccine within 30 days of planned start of study therapy",{"count":190,"type":20},28,[23,24],"This is a Phase I\u002FII open-label, efficacy and safety study of bicalutamide in combination with sunitinib in patients with advanced renal cell carcinoma (RCC) who have been treated with a receptor tyrosine kinase inhibitor (RTKI) and experienced disease progression.",[32],"2026-03-26",{"date":196,"type":54},"2026-04-01",{"date":198,"type":54},"2024-10-01",{"date":200,"type":20},"2027-07-01",{"name":202,"class":203},"State University of New York at Buffalo","OTHER",1,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":214,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":218,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":204},"100631450","fasting-mimicking-diet-combined-with-io-tki-combination-therapy-in-patients-with-metastatic-renal-cell-carcinoma-100631450","NCT07500831","Fasting-Mimicking Diet Combined With IO-TKI Combination Therapy in Patients With Metastatic Renal Cell Carcinoma","Fasting-Mimicking Diet Combined With Toripalimab Plus Axitinib for Metastatic or Unresectable Renal Cell Carcinoma: A Single-Arm, Open-Label, Single-Center Clinical Trial","Inclusion Criteria:\n\n1. Subjects voluntarily participate in the study and sign the informed consent form.\n2. Age ≥ 18 years at the time of signing the informed consent form; males or females are eligible.\n3. Pathologically confirmed advanced renal cell carcinoma (metastatic or unresectable) with predominant clear cell histology.\n4. No prior systemic anti-tumor therapy (except for cytokine therapy).\n5. At least one measurable target lesion according to RECIST v1.1 criteria (confirmed by CT or MRI).\n6. Body mass index (BMI) ≥ 20 kg\u002Fm².\n7. IMDC intermediate- or poor-risk group.\n8. Willing and able to comply with the fasting-mimicking diet (FMD)protocol,scheduled visits, treatment plan, laboratory tests, and other study procedures.\n9. Able to maintain daily contact with the investigator (via telephone or email) to communicate key clinical information, including daily body weight, blood pressure, health status, and adverse events during the 5-day FMD period.\n10. Low nutritional risk according to the Nutritional Risk Screening (NRS) tool.\n11. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n12. Adequate organ function within 7 days prior to the first dose of study drug (no blood products, hematopoietic growth factors, leukocyte- or platelet-stimulating agents allowed in the 7 days prior to laboratory testing):\n\n    Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL Platelets ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL Serum albumin ≥ 30 g\u002FL AST and ALT ≤ 2.5 × upper limit of normal (ULN); if liver metastases are present, AST and ALT ≤ 5 × ULN Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN allowed for subjects with Gilbert syndrome) Serum creatinine ≤ 1.5 × ULN; if \\> 1.5 × ULN, creatinine clearance (CLcr) calculated by Cockcroft-Gault formula must be ≥ 50 mL\u002Fmin Left ventricular ejection fraction (LVEF) \\> 50% Proteinuria \\\u003C 2+ (if ≥ 2+, 24-hour urine protein quantification must be \\\u003C 1 g) International normalized ratio (INR) ≤ 1.5 × ULN or prothrombin time (PT) prolongation ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN\n13. No plans for pregnancy during the study period.\n\nExclusion Criteria:\n\n1. Prior receipt of any systemic anti-tumor therapy for renal cell carcinoma (RCC), including systemic chemotherapy, anti-angiogenic therapy, molecular targeted therapy, immunotherapy containing anti-CTLA-4, anti-PD-1\u002FPD-L1 monoclonal antibodies, and immune checkpoint agonist antibodies (e.g., anti-ICOS, anti-CD40, anti-CD137, anti-GITR, or anti-OX40 antibodies).\n2. Unintentional weight loss ≥5% within the past 3 months, unless the patient has BMI \\>22 kg\u002Fm² and weight loss at study entry is \\\u003C10%; or unintentional weight loss ≥10% within the past 3 months, unless the patient has BMI \\>25 kg\u002Fm² and weight loss at study entry is \\\u003C15% (in both cases, body weight must have been stable for at least 1 month prior to study entry).\n3. Body mass index (BMI) \\\u003C20 kg\u002Fm².\n4. Moderate or high nutritional risk according to the Nutritional Risk Screening (NRS) assessment.\n5. Severe food allergy that prevents the subject from consuming the foods required for the fasting-mimicking diet (FMD).\n6. Symptomatic central nervous system (CNS) metastases, leptomeningeal metastases, or spinal cord compression due to metastases prior to the first dose of study treatment. Exception: Patients with symptomatic CNS metastases who have received treatment and are stable for ≥4 weeks (stable defined as no radiographic progression and resolution of metastasis-related symptoms) and have discontinued systemic corticosteroids (any dose), anticonvulsants, and mannitol for \\>2 weeks may be enrolled.\n7. History of other malignancies within 5 years prior to signing the informed consent form (except for cured basal cell skin carcinoma, papillary thyroid carcinoma, etc.).\n8. Active autoimmune disease requiring systemic treatment (e.g., corticosteroids or immunosuppressants) within the past 2 years prior to the first dose of the combination therapy.\n9. Any serious concomitant disease, as judged by the investigator, that may endanger the subject's safety or interfere with the subject's ability to complete the study.\n10. Receiving long-term systemic corticosteroid therapy (daily dose \\>10 mg prednisone equivalent) within 7 days prior to the first dose of the combination therapy.\n11. Any of the following cardiovascular diseases:\n\n    Acute myocardial infarction within 6 months prior to the first dose of the combination therapy.\n\n    History of and\u002For current New York Heart Association (NYHA) Class III or IV heart failure.\n\n    Poorly controlled cardiovascular disease, including angina, pulmonary hypertension, or severe cardiac rhythm or conduction abnormalities.\n\n    Mean QT interval corrected by Fridericia's formula (QTcF) \\>450 ms (male) or \\>470 ms (female) on 12-lead electrocardiogram (ECG) prior to the first dose of the combination therapy.\n12. Known history of substance abuse of psychotropic medications, alcohol abuse, or drug abuse; or history of definite neurological or psychiatric disorders, including epilepsy, dementia, or hepatic encephalopathy.\n13. Participation in another clinical study and receipt of other investigational therapy within 4 weeks prior to the first dose of the combination therapy.\n14. Major surgery within 4 weeks prior to the first dose of the combination therapy (adequate wound healing after major surgery must be clinically assessed).\n15. Arteriovenous thromboembolic events within 6 months prior to the first dose of the combination therapy, including cerebrovascular accident, history of stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other serious thromboembolic events.\n16. Any patient, as judged by the investigator, who may increase the risk associated with the study, interfere with the interpretation of study results, or is deemed unsuitable for enrollment by the investigator and\u002For sponsor.",{"count":213,"type":20},43,[215],"NA","This study is testing whether adding a 5-day fasting-mimicking diet (FMD) can help people with advanced kidney cancer when given together with standard first-line cancer medicines.",[32,124,120],"NOT_YET_RECRUITING","2026-03-24",{"date":221,"type":54},"2026-03-30",{"date":223,"type":20},"2026-04",{"date":225,"type":20},"2029-04",{"name":227,"class":203},"Qilu Hospital of Shandong University",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":235,"enrollmentInfo":236,"targetDuration":238,"studyType":239,"phases":4,"briefSummary":240,"conditions":241,"keywords":254,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":204},"100568077","vorolanib-in-the-second-line-treatment-of-patients-with-unresectable-or-metastatic-renal-cell-carcinoma-100568077","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.","80 Years",{"count":237,"type":20},39,"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.",[242,243,244,245,246,247,248,249,250,251,252,32,253],"Neoplasms","Kidney Neoplasms","Urologic Neoplasms","Urogenital Neoplasms","Female Urogenital Diseases","Male Urogenital Diseases","Urogenital Diseases","Kidney Diseases","Urologic Diseases","Carcinoma","Renal Cell Cancer","Antineoplastic Agents",[255,256,257],"observational study","clear cell Renal Cell Carcinoma","TKIs","2025-12-04",{"date":260,"type":54},"2025-12-05",{"date":262,"type":54},"2024-09-01",{"date":264,"type":20},"2026-09-01",{"name":266,"class":203},"Jinling Hospital, China",{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":273,"sex":16,"minAge":17,"maxAge":274,"enrollmentInfo":275,"targetDuration":4,"studyType":239,"phases":4,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":286,"leadSponsor":288,"locationsCount":204},"100605740","deep-learning-for-automated-discrimination-between-stage-t1-t2-and-t3-renal-cell-carcinoma-on-contrast-enhanced-ct-100605740","NCT07166445","Deep Learning for Automated Discrimination Between Stage T1-T2 and T3 Renal Cell Carcinoma on Contrast-Enhanced CT","Inclusion Criteria:\n\n1. Histopathologically confirmed renal cell carcinoma on postoperative specimen.\n2. Preoperative contrast-enhanced CT performed at our institution with slice thickness ≤ 1 mm and complete DICOM datasets.\n3. Postoperative pathologic staging clearly defined as pT1a-T2b or pT3a.\n4. CT image quality deemed adequate for analysis.\n\nExclusion Criteria:\n\n* 1\\. Pathologic subtype other than RCC. 2. Images with severe artifacts.",true,"85 Years",{"count":276,"type":20},1000,"This study aims to develop and validate a contrast-enhanced CT-based deep-learning model for automatic and accurate preoperative discrimination between T1-T2 and T3 renal cell carcinoma. By quantifying the model's diagnostic performance on an independent test set-using AUC, sensitivity, specificity, positive\u002Fnegative predictive values, and decision-curve analysis-we will establish a decision-support tool that can be seamlessly integrated into clinical PACS, thereby reducing staging errors, refining surgical planning, and improving patient outcomes.",[32,279,280,281],"Diagnostic Imaging","Pathology","Deep Learning","2025-09-03",{"date":284,"type":54},"2025-09-10",{"date":262,"type":54},{"date":287,"type":20},"2027-12-01",{"name":289,"class":203},"Peking University First Hospital",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":302,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":204},"100449080","phase-2-autologous-dendritic-cell-vaccine-in-kidney-cancer-100449080","NCT05127824","Autologous Dendritic Cell Vaccine in Kidney Cancer","A Phase 2a Study to Type I-Polarized Autologous Dendritic Cell Vaccines Incorporating Tumor Blood Vessel Antigen (TBVA)-Derived Peptides in Combination With Cabozantinib in Patients With Localized Clear Cell Renal Cancer.","Inclusion Criteria:\n\n1. Histologically proven clear cell renal cancer that is non-metastatic and amenable to surgical resection with no evidence of metastatic disease or lesions outside of the kidney.\n2. 18 years or older (male or female) with an ECOG performance status of 0 or 1.\n3. Have serotype HLA-A2+ if receiving vaccine.\n4. Capable of understanding and complying with the protocol requirements and have signed the informed consent document.\n5. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment:\n\n   1. Absolute neutrophil count (ANC) ≥ 1500\u002FµL without granulocyte colony- stimulating factor support.\n   2. White blood cell count ≥ 2500\u002FµL.\n   3. Platelets ≥ 100,000\u002FµL without transfusion.\n   4. Hemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL).\n   5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3x upper limit of normal (ULN). ALP ≤ 5x ULN with documented bone metastases.\n   6. Total bilirubin ≤ 1.5x ULN (for subjects with Gilbert's disease ≤ 3x ULN).\n   7. Serum albumin ≥ 2.8 g\u002Fdl\n   8. (PT)\u002FINR or partial thromboplastin time (PTT) test \\\u003C 1.3x the laboratory ULN\n   9. Serum creatinine ≤ 2.0 ULN or calculated creatinine clearance ≥ 30 mL\u002Fmin (≥ 0.5 mL\u002Fsec) using the Cockcroft-Gault equation: Males: (140 - age) x weight (kg)\u002F(serum creatinine \\[mg\u002FdL\\] × 72) Females: \\[(140 - age) x weight (kg)\u002F(serum creatinine \\[mg\u002FdL\\] × 72)\\] × 0.85\n   10. Urine protein\u002Fcreatinine ratio (UPCR) ≤ 1 mg\u002Fmg (≤ 113.2 mg\u002Fmmol), or 24-h urine protein ≤ 1\n6. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment.\n7. Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating (FSH) level \\> 40 mIU\u002FmL to confirm menopause). Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site.\n\nExclusion Criteria:\n\n1. Current (within the preceding 6 weeks) treatment with systemic immunosuppressive agents including steroids except when they are administered as replacement therapy for endocrine dysfunction and do not exceed 10 mg prednisone or equivalent daily.\n2. Known or suspected metastatic disease.\n3. Active Hepatitis B or Hepatitis C infection or any other active infection requiring intravenous therapy.\n4. Blood transfusion within two weeks prior to leukapheresis.\n5. Prior treatment with cabozantinib.\n6. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within two weeks before first dose of study treatment.\n7. Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within four weeks before first dose of study treatment.\n8. Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n9. Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:\n\n   1. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n   2. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.\n10. Prothrombin time (PT\u002FINR) or partial thromboplastin time (PTT) test ≥ 1.3 X the laboratory ULN within 7 days before the first dose of study treatment.\n11. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n    a. Cardiovascular disorders: i. Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.\n\n    ii. Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n\n    iii. Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose of study treatment.\n    1. Subjects with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion #6) for at least 1 week before first dose of study treatment.\n    2. Gastrointestinal disorders:\n\n    i. The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.\n\n    ii. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment.\n\n    iii. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n12. Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n13. Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.\n14. Lesions invading or encasing any major blood vessels.\n15. Other clinically significant disorders that would preclude safe study participation.\n\n    1. Serious non-healing wound\u002Fulcer\u002Fbone fracture.\n    2. Uncompensated\u002Fsymptomatic hypothyroidism.\n    3. Moderate to severe hepatic impairment (Child-Pugh B or C).\n16. Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Minor surgeries within 10 days before first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.\n17. Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment \\[add reference for Fridericia formula\\].\n\n    Note: If a single ECG shows a QTcF with an absolute value \\> 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility.\n18. Pregnant or lactating females.\n19. Inability to swallow tablets.\n20. Previously identified allergy or hypersensitivity to components of the study treatment formulations.\n21. Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n22. Any other conditions considered as unacceptable risk by the treating physician.",{"count":298,"type":20},42,[24],"The purpose of this study is to estimate the probability of immune response for the combination treatment of dendritic cell vaccine with oral cabozantinib and characterize the safety profile of interventional therapy.",[32],[123],"2025-04-30",{"date":305,"type":54},"2025-05-04",{"date":307,"type":54},"2023-07-06",{"date":309,"type":20},"2026-12",{"name":311,"class":203},"Jodi Maranchie",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":239,"phases":4,"briefSummary":321,"conditions":322,"keywords":323,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":333,"locationsCount":204},"100531044","mechanisms-of-somatic-mutation-and-tumor-initiation-in-pre-malignant-kidney-tubule-cells-100531044","NCT06194669","Mechanisms of Somatic Mutation and Tumor Initiation in Pre-malignant Kidney Tubule Cells","SoMuKT","Inclusion Criteria:\n\n* Genetic diagnosis of VHL-disease; age (data need to be collected from a population distributed between 25 and 65 years); gender (males and females should be equally represented);\n\nExclusion Criteria:\n\n* patients with bilateral nephrectomy, in dialysis or kidney transplant; use of nephrotoxic drugs",{"count":320,"type":20},50,"The goal of this observational study is to analyze somatic mutations in the genome of normal kidney cells from patients affected by kidney cancer predisposition syndrome Von Hippel Lindau (VHL) and compare the mutation rates observed in these patients and in individuals not affected by the disease. The main questions the study aims to answer are:\n\n* Do kidney cells from VHL patients mutate more than cells from control individuals during adult life?\n* What mechanisms favor somatic mutation occurrence in the genome of normal kidney tubule cells?\n\nParticipants will donate one blood sample and multiple urine samples. Urines will be used for kidney cell isolation, followed by cell culturing and genetic analyses. Urine samples will be collected once a year for 3-5 years. Sample collection will occur during the yearly screening program that each patient undergoes at the hospital. In case patients undergo surgical treatment of kidney tumors, samples discarded from surgery (tumor and normal kidney adjacent to tumor) will be collected and subjected to genetic analyses.\n\nResearchers will compare the number and types of mutations found in tumors and normal kidney cells from VHL-disease patients with those found in normal kidney cells from control individuals, to see if somatic mutation rates are increased in VHL-disease patients during aging.",[32,98],[324,325,326],"Somatic mutations","Whole genome sequencing","Normal kidney","2024-01-08",{"date":329,"type":54},"2024-01-10",{"date":331,"type":54},"2023-06-30",{"date":178,"type":20},{"name":334,"class":203},"IRCCS San Raffaele",{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":21,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":357},"100505772","phase-2-a-study-of-oncobax-ak-in-patients-with-advanced-solid-tumors-100505772","NCT05865730","A Study of Oncobax®-AK in Patients With Advanced Solid Tumors","A Phase 1\u002F2 Study of Oncobax®-AK Administered in Combination With Immunotherapy To Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Histologically confirmed Stage IV non-squamous NSCLC or clear cell RCC\n3. NSCLC-specific criterion: Best tumor response (by iRECIST) as Stable Disease\n4. NSCLC-specific criterion: PD-L1 expression \\> 50%\n5. ECOG Performance Status = 0-1\n6. Negative stool PCR test for Akkermansia\n7. At least one measurable lesion per iRECIST\n8. Hemoglobin ≥ 100 g\u002FL\n9. Albumin \\> 35 g\u002FL\n10. Signed informed consent\n\nExclusion Criteria:\n\n1. Symptomatic brain metastases\n2. AST or ALT \\> 5 x ULN\n3. Calculated creatinine clearance \\\u003C 45 ml\u002Fmin\n4. Auto-immune diseases requiring systemic therapy\n5. Immunosuppressive therapy (\\> 10 mg prednisone\u002Fday equivalent)\n6. Radiotherapy (\\> 30 Gy) to the lung(s) within 6 months of signed informed consent\n7. Active infection\n8. Co-morbidities that may increase the risk of treatment-related adverse events\n9. Pregnancy\n10. Inability to comply with protocol-specific assessments",{"count":343,"type":20},122,[24],"Akkermansia muciniphila is a naturally occurring bacterium found in the healthy human gastrointestinal tract.\n\nAnalysis of the gut microbiota of NSCLC or RCC patients shows that the presence of Akkermansia is associated with the clinical efficacy of immunotherapy. In preclinical models, oral administration of the Akkermansia p2261 strain reverses resistance to PD-1 blockade. In the clinical setting, it is therefore hypothesized that the oral administration of Oncobax®-AK to cancer patients under immunotherapy, but whose gut microbiota is deficient in Akkermansia will restore \u002F improve the efficacy of immunotherapy in patients with NSCLC or RCC.",[32,347],"Carcinoma, Non-Small-Cell Lung","2023-05-09",{"date":350,"type":54},"2023-05-19",{"date":352,"type":54},"2022-10-01",{"date":354,"type":20},"2026-06",{"name":356,"class":61},"EverImmune",4,{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":239,"phases":4,"briefSummary":367,"conditions":368,"keywords":372,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":204},"100484527","predicting-model-based-on-evidence-based-pathological-diagnose-criteria-for-rcc-tumor-thrombus-with-ivc-wall-invasion-100484527","NCT05589207","Predicting Model Based on Evidence-based Pathological Diagnose Criteria for RCC Tumor Thrombus With IVC Wall Invasion","Preoperative Imaging Diagnostic Evaluation Model Based on Evidence-based Pathological Diagnose Criteria for Renal Cell Carcinoma Tumor Thrombus With Inferior Vena Cava Wall Invasion","Inclusion Criteria:\n\n* Adults ≥18 years of age;\n* Accepted abdominal ultrasonography, contrast-induced ultrasonography, enhanced CT and MRI before the surgery;\n* Diagnosis of primary renal cell carcinoma with tumor thrombus before and during the surgery;\n* Received radical nephrectomy and at least one kind of thrombectomy (including IVC incision only, IVC partial resection, IVC diagonal resection, and IVC segmental resection)\n* Can tolerate the surgery;\n* Eastern Cooperative Oncology Group Performance Status Scale (ECOG-PS) 0\\~2;\n* No previous history of malignant tumor;\n* Willing to return for required follow-up visits\n\nExclusion Criteria:\n\n* Failed to receive standard nephrectomy for any reason;\n* Attached other addition operations in the surgery;\n* Received neoadjuvant treatment before the surgery;\n* Experience any other conditions that may affect the curative effect (e.g. active tuberculosis, autoimmune disease, or oral glucocorticoids treatment);\n* Experience serious consequences or death due to anesthesia accident during operation;",{"count":366,"type":20},232,"The goal of this observational study is to establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations, as well as a accurate and systematic pathological grading standard of inferior vena cava (IVC) vascular wall invasion in renal cell carcinoma (RCC) with tumor thrombus invading vascular wall.The main questions it aims to answer are:\n\n* To establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations.\n* To determine what impact does different vascular wall layer invasion make on the long-term prognosis in RCC with IVC tumor thrombus;\n* To determine which layer invasion according to pathological examination make sense to clinical treatment (can significantly affect prognosis); Participants with IVC vascular wall invasion\u002F non-invasion are divided into experimental group (invaded group) or control group (non-invaded group) respectively according to pathological examinations, in order to establish a prospective cohort with three-year follow-up. The pathological characteristics of local recurrence and poor prognosis are summarized, and postoperative pathological diagnostic criteria of IVC vascular wall invasion and established. The local recurrence and distant recurrence outcomes are compared between experiment group and control group, in order to analyze the long-term influence of vascular wall invasion. Then the preoperative imaging diagnostic evaluation model will be established.",[32,369,370,371],"Tumor Thrombus","Neoplasm Invasiveness","Inferior Vena Cava Interruption",[373,374,375],"Neoplasm Grading","Diagnostic Model","Preoperative Diagnosis","2023-02-16",{"date":378,"type":54},"2023-02-21",{"date":380,"type":54},"2023-01-01",{"date":382,"type":20},"2027-01-01",{"name":384,"class":203},"Peking University Third Hospital"]