[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tianjin Medical University Second Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":533},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,48,71,97,126,149,175,197,219,238,266,291,320,342,369,393,412,429,452,471,492,510],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100617637","radical-nephroureterectomy-with-vs-without-template-lymph-node-dissection-in-high-risk-upper-tract-urothelial-carcinoma-t-lnd-utuc-100617637",false,"NCT07321210","Radical Nephroureterectomy With vs Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma (T-LND UTUC)","Clinical Efficacy and Safety of Radical Nephroureterectomy With Versus Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma: A Multicenter, Prospective, Randomized Controlled Clinical Trial","UTLUND","Inclusion Criteria:\n\n* Signed written informed consent form (ICF).\n* Age \\> 18 years at the time of ICF signing.\n* Clinical diagnosis of unilateral Upper Tract Urothelial Carcinoma (UTUC) by imaging (enhanced CT or MRI) and\u002For ureteroscopic biopsy\u002Furinary cytology, and scheduled to undergo Radical Nephroureterectomy (RNU).\n* Clinical assessment indicating that the tumor and regional lymph nodes are completely resectable, with at least one of the following high-risk features:\n\n  1. Locally advanced: Preoperative imaging assessed as cT2 stage or higher (i.e., tumor invades muscularis propria or deeper).\n  2. High-grade: Preoperative ureteroscopic biopsy pathology confirmed as high-grade urothelial carcinoma (or with squamous differentiation\u002Fsarcomatoid differentiation).\n  3. Moderate or severe hydronephrosis: Ipsilateral moderate or severe hydronephrosis due to tumor obstruction.\n  4. Large tumor size: Imaging measures maximum tumor diameter \\> 2 cm.\n  5. cN1: Imaging suggests regional lymph node short-axis diameter \\> 1 cm, and the investigator judges it to be resectable.\n* Presence of at least one measurable lesion according to RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function meeting the following requirements (without use of any blood components or colony-stimulating factors within 14 days):\n\nBone marrow function: Neutrophils ≥ 1,500\u002Fmm³, Platelets ≥ 100,000\u002Fmm³, Hemoglobin ≥ 9 g\u002FdL (5.6 mmol\u002FL).\n\nRenal function: Serum creatinine ≤ 1.5 mg\u002FdL and\u002For Creatinine clearance ≥ 60 mL\u002Fmin.\n\nLiver function: Total bilirubin ≤ 1.5 × ULN, AST \\& ALT ≤ 1.5 × ULN.\n\n* For women of childbearing potential (WOCBP): Must agree to use a highly effective medically approved contraceptive method during the treatment period and for 3 months after treatment ends. A negative serum or urine pregnancy test within 7 days before enrollment is required; must be non-lactating. For non-sterilized male patients: Must agree to use effective contraception with their partner during the treatment period and for 3 months after treatment ends.\n* Subject voluntarily joins the study, has good compliance, and agrees to undergo safety and survival follow-up.\n\nExclusion Criteria:\n\n* Previous receipt of any anti-tumor therapy for UTUC, including chemotherapy, radiotherapy, immunotherapy, or targeted therapy.\n* History or concurrent presence of muscle-invasive bladder urothelial carcinoma.\n* Preoperative imaging assesses regional lymph nodes as unresectable: lymph nodes fused into a massive conglomerate, or fully encasing the abdominal aorta\u002Finferior vena cava\u002Fpelvic vessels preventing safe separation.\n* Known bilateral UTUC or hereditary diseases that definitively increase the risk of contralateral upper tract tumors, such as Lynch Syndrome.\n* Diagnosis of other active malignancies within the past 5 years (except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix which have been cured and show no recurrence within 5 years).\n* Presence of any active autoimmune disease or history of autoimmune disease.\n* Current use of immunosuppressants for immunosuppressive purposes, continued within 2 weeks prior to enrollment.\n* Poorly controlled cardiac clinical symptoms or diseases.\n* Coagulation abnormalities or bleeding tendency.\n* Presence of specific active gastrointestinal conditions or uncontrolled tumor bleeding.\n* History of significant bleeding, hemoptysis, or thromboembolic events within specified timeframes.\n* Active infection or unexplained fever \\> 38.5°C during screening or before the first dose.\n* Occurrence of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to surgery.\n* History or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function, etc.\n* Congenital or acquired immunodeficiency.\n* Participation in another clinical study within 1 month prior to enrollment, or potential receipt of other systemic anti-tumor therapy during the study period.\n* Known history of psychotropic drug abuse, alcohol abuse, or drug use.\n* Inability or unwillingness to bear the out-of-pocket costs of examinations and treatments.\n* Any other condition deemed by the investigator to make the subject unsuitable for participation.","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if adding a template lymph node dissection (TLND) to the standard surgery for upper tract urothelial cancer (UTUC) can improve patient survival and prevent the cancer from recurrence. The main questions it aims to answer are:\n\nDo patients who receive standard surgery with LND live longer without their cancer returning? Is adding LND safe, and how does it affect surgery-related complications? Researchers will compare the group receiving standard surgery plus LND to the group receiving standard surgery alone to see if adding LND is more effective.\n\nParticipants will:\n\nBe randomly assigned to one of the two surgical groups. Undergo their assigned surgery and recover in the hospital. Attend regular follow-up visits for checkups and scans for 5 years to monitor for cancer recurrence, with the possibility of long-term follow-up extending to 10 years.",[27,28],"Upper Tract Urothelial Carcinoma","Lymph Node Dissection",[30,31,32,33,34],"Upper tract urothelial carcinoma (UTUC)","Template Lymph node dissection","Nephroureterectomy","High-risk neoplasm","Randomized Controlled Trial","RECRUITING","2026-06-22",{"date":38,"type":39},"2026-06-25","ACTUAL",{"date":41,"type":39},"2025-09-01",{"date":43,"type":21},"2032-08-30",{"name":45,"class":46},"Tianjin Medical University Second Hospital","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":47},"100617636","radical-nephrectomy-with-vs-without-template-lymph-node-dissection-in-high-risk-renal-cell-carcinoma-t-lnd-rcc-100617636","NCT07321197","Radical Nephrectomy With vs Without Template Lymph Node Dissection in High-Risk Renal Cell Carcinoma (T-LND RCC)","Template Lymph Node Dissection for Tumor Control in High-Risk Renal Cell Carcinoma: A Prospective, Open-Label, Multicenter, Randomized Controlled Trial","RECLND","Inclusion Criteria:\n\n* Signed informed consent form.\n* Age \\> 18 years.\n* Candidate for radical nephrectomy with or without lymph node dissection.\n* High-risk renal cell carcinoma defined as: At least ONE of: Clinical stage cT3-4 N0-1 M0 (AJCC 8th ed); OR radiologically visible lymph node \\>1cm; OR M1 disease rendered no evidence of disease (NED) after local therapy; OR radiologically determined rT4 stage. OR at least TWO of: Renal vein or inferior vena cava tumor thrombus; OR nuclear grade 3-4 or sarcomatoid differentiation or coagulative necrosis; OR tumor size \\>= 10cm; OR hematuria and\u002For local symptoms.\n* Measurable disease as per RECIST v1.1.\n* ECOG performance status of 0 or 1.\n* Adequate bone marrow, renal, and hepatic function.\n* For women and men of childbearing potential, agreement to use effective contraception during the study period.\n\nExclusion Criteria:\n\n* Prior radiotherapy, chemotherapy, major surgery, or targeted therapy for RCC.\n* Concurrent other active malignancy (except controlled malignancies not affecting 2-year survival).\n* Candidate for partial nephrectomy or ablation per multidisciplinary team assessment.\n* Preoperative imaging indicates unresectable regional lymph nodes.\n* renal tumors or known hereditary RCC syndrome.\n* Diagnosis of any other active malignancy within the past 5 years.\n* Active autoimmune disease or history of autoimmune disease.\n* Use of immunosuppressive agents within 2 weeks prior to enrollment.\n* Poorly controlled cardiac or clinical symptoms.\n* Coagulopathy or bleeding tendency.\n* Active gastrointestinal conditions with risk of bleeding or perforation.\n* History of significant bleeding or thromboembolic events within specified timeframes.\n* Active infection or unexplained fever \\>38.5°C.\n* Abdominal fistula, gastrointestinal perforation, or abscess within 4 weeks prior.\n* History of pulmonary fibrosis, interstitial lung disease, or severely impaired pulmonary function.\n* Known immunodeficiency or active hepatitis.\n* Participation in another clinical trial within 1 month.\n* Known history of drug abuse or alcohol addiction.\n* Inability or unwillingness to bear the self-paid portion of examination and treatment costs.\n* Any condition that, in the investigator's judgment, may compromise patient safety or study conduct.",{"count":57,"type":21},220,[24],"The goal of this clinical trial is to learn if a more thorough lymph node removal surgery, called \"Template Lymph Node Dissection,\" can help prevent cancer from returning and help patients live longer, compared to removing only a few enlarged lymph nodes, in patients with high-risk kidney cancer. The main questions it aims to answer are:\n\nDo patients who receive template lymph node dissection live longer without their cancer returning (Disease-Free Survival)? Do patients who receive template lymph node dissection live longer overall (Overall Survival)? Is the more extensive lymph node surgery as safe as the limited surgery? Researchers will compare the Template Lymph Node Dissection group to the Limited Node Resection group to see the effects on cancer control and safety.\n\nParticipants will:\n\nBe randomly assigned to one of the two surgical groups. Undergo surgery to remove their kidney and the assigned lymph nodes. Attend regular follow-up visits with imaging scans (like CT or MRI) for the first 5 years after surgery to monitor if the cancer returns.\n\nBe followed for their overall survival status for up to 10 years.",[61],"Renal Cell Carcinoma (Kidney Cancer)",[63,64,34,65],"Template Lymph Node Dissection","High-Risk Neoplasm","Surgical Oncology",{"date":38,"type":39},{"date":41,"type":39},{"date":69,"type":21},"2033-09-30",{"name":45,"class":46},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":47},"100641093","study-on-mrd-prediction-of-efficacy-of-toripalimab-in-the-treatment-of-high-risk-recurrent-renal-carcinoma-100641093","NCT07657325","Study on MRD Prediction of Efficacy of Toripalimab in the Treatment of High-risk Recurrent Renal Carcinoma","Predictive Value of Minimal Residual Disease for Efficacy of Toripalimab in High-risk Recurrent Renal Cell Carcinoma Following Nephrectomy: A Prospective Single-arm Study","1. There must be a histological diagnosis of renal cell carcinoma, with or without sarcomatoid features of clear cell components.\n2. On the day of signing the informed consent form, both males and females must be at least 18 years old.\n3. The participants provide written informed consent for the trial before enrollment.\n4. Have high risk or M1 NED renal cell carcinoma as defined by the following pathological tumor-node-metastasis and Fuhrman grading status.\n\n   1. High risk RCC\n\n      * pT4, Any Gr. N0, M0\n      * pT Any stage, Any Gr., N+, M0\n   2. M1 NED RCC (participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at the time of nephrectomy)\n5. No previous systemic treatment for advanced RCC (except nephrectomy or pyelectomy) has been performed.\n6. Radical nephrectomy (and complete resection of metastatic lesions in M1 NED participants) was performed with a negative surgical margin.\n7. It must be evaluated by the investigator as tumor-free and verified by imaging such as CT or MRI. No suspicious brain metastases.\n8. Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n9. Non-surgical sterilization or female participants of childbearing potential who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 3 months after the end of the study treatment period; Serum or urine HCG tests must be negative for women of non-surgical sterilization or childbearing age within 7 days prior to study enrollment; And must be non-lactation period; Non-surgical sterilization or male patients of childbearing age who consent to use a medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the end of the study treatment period.\n10. Vital organ function meets the following requirements (excluding use of any blood components and cell growth factors within 14 days) : normal bone marrow reserve function; Absolute neutrophil count (ANC)≥1500\u002FµL, Platelets≥100 000\u002FµL, Hemoglobin ≥5.6 mmol\u002FL (9g\u002FdL); Normal renal function or serum creatinine ≤1.5 mg\u002Fd and\u002For creatinine clearance ≥30 mL\u002Fmin for participants with creatinine levels \\>1.5×institutional ULN; Normal liver function or Total bilirubin ≤1.5xULN, or direct bilirubin≤ULN for participants with total bilirubin levels \\>1.5×ULN; AST (SGOT) and ALT (SGPT) ≤2.5×ULN; International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.",{"count":79,"type":21},110,"OBSERVATIONAL","This is a prospective cohort study aimed at clarifying the predictive value of MRD for postoperative DFS and OS in high-risk recurrent renal cell carcinoma patients who have undergone radical nephrectomy and received adjuvant treatment with Toripalimab. Further differentiating patients who need adjuvant immunotherapy.",[83],"Renal Cell Carcinoma (RCC)",[85,86,87,88],"Minimal Residual Disease","Toripalimab","Renal Cell Carcinoma","Disease Free Survival","2026-06-15",{"date":91,"type":39},"2026-06-18",{"date":93,"type":39},"2024-04-01",{"date":95,"type":21},"2028-02-01",{"name":45,"class":46},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100638648","phase-2-is-prolonged-systemic-immunotherapy-necessary-after-achieving-tumor-free-status-in-patients-with-extensive-transurethrally-unresectable-very-high-risk-nmibc-100638648","NCT07625527","Is Prolonged Systemic Immunotherapy Necessary After Achieving Tumor-free Status in Patients With Extensive Transurethrally Unresectable Very-high-risk NMIBC?","Randomized Trial of Active Surveillance Versus Continued Systemic Immunotherapy After Achieving Tumor-Free Status in Extensive Transurethrally Unresectable Very-High-Risk NMIBC","Inclusion Criteria\n\n* Has histologically confirmed very-high-risk non-muscle-invasive urothelial carcinoma of the bladder.\n* Has transurethrally unresectable bladder tumor, defined as visually incomplete TURBT and\u002For extensive high-volume disease considered unsuitable for complete and oncologically adequate transurethral resection.\n* Has undergone cystoscopy and TURBT evaluation before study enrollment.\n* Has received systemic PD-1\u002FPD-L1 inhibitor-based bladder-sparing therapy before randomization.\n* Has achieved tumor-free status before randomization, defined as:\n\n  1. No visible bladder tumor on cystoscopy;\n  2. Negative bladder biopsy and\u002For TURBT pathology;\n  3. Negative urine cytology;\n  4. Negative urinary tumor DNA (utDNA);\n  5. No radiographic evidence of progression or metastasis.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n* Has adequate organ function.\n* Has provided written informed consent.\n\nCohort A Only\n\n* Achieved tumor-free status at the initial response evaluation after induction systemic therapy.\n* Maintained tumor-free status after additional systemic therapy before randomization.\n\nCohort B Only\n\n* Did not achieve tumor-free status at the initial response evaluation because of residual non-muscle-invasive disease.\n* Subsequently underwent complete TURBT\u002Fresection of residual disease followed by additional systemic therapy.\n* Achieved tumor-free status at the second response evaluation before randomization.\n\nExclusion Criteria\n\n* Has muscle-invasive bladder cancer (≥T2), locally advanced unresectable disease, nodal disease, or distant metastasis.\n* Has concurrent upper tract urothelial carcinoma.\n* Has persistent visible tumor, positive bladder pathology, positive urine cytology, or positive utDNA before randomization.\n* Has received prior systemic immunotherapy for metastatic urothelial carcinoma.\n* Has active autoimmune disease requiring systemic treatment.\n* Is receiving systemic immunosuppressive therapy.\n* Has uncontrolled infection requiring systemic therapy.\n* Has another active malignancy requiring systemic treatment.\n* Has known active hepatitis B, hepatitis C, human immunodeficiency virus infection, or active tuberculosis.\n* Has pregnancy or breastfeeding.\n* Has any medical or psychiatric condition that, in the investigator's judgment, would interfere with study participation or interpretation of results.",{"count":105,"type":21},120,[107],"PHASE2","Patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC) may achieve a tumor-free status after systemic immunotherapy-based bladder-sparing treatment combined with transurethral resection of bladder tumor (TURBT). However, the optimal duration of systemic immunotherapy after achieving a tumor-free status remains uncertain. Prolonged treatment may increase toxicity, treatment burden, and cost, while some patients may maintain durable disease control without continued therapy.\n\nThis randomized study aims to evaluate whether active surveillance after achieving tumor-free status is a feasible alternative to continued systemic immunotherapy in patients with extensive transurethrally unresectable very-high-risk NMIBC.\n\nPatients will initially receive systemic immunotherapy-based treatment followed by disease evaluation using cystoscopy with biopsy and\u002For TURBT, urine cytology, urinary tumor DNA (utDNA), and imaging assessments. Patients who achieve tumor-free status after treatment and complete resection of visible disease will be randomized to either active surveillance or continued systemic immunotherapy.\n\nThe study will evaluate recurrence outcomes, bladder preservation, progression, safety, and patient management strategies following achievement of tumor-free status. The trial also aims to explore the role of urinary tumor DNA in identifying patients who may safely undergo treatment de-escalation and active surveillance.",[110,111],"Bladder (Urothelial, Transitional Cell) Cancer","Non Muscle Invasive Bladder Cancer",[113,114,115],"Non-muscle-invasive bladder cancer (NMIBC)","Liquid biopsy","Immunotherapy","NOT_YET_RECRUITING","2026-05-28",{"date":119,"type":39},"2026-06-04",{"date":121,"type":21},"2026-05-30",{"date":123,"type":21},"2032-05-30",{"name":45,"class":46},4,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100629494","phase-2-urinary-tumor-dna-guided-systemic-immunotherapy-for-unresectable-very-high-risk-non-muscle-invasive-bladder-cancer-100629494","NCT07475403","Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer","A Prospective Study of Urinary Tumor DNA-Guided Systemic Immunotherapy in Patients With Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically confirmed non-muscle-invasive urothelial carcinoma of the bladder classified as very-high-risk (VHR) according to EAU 2025 guideline criteria.\n3. Disease considered unresectable by the investigator and multidisciplinary team, defined as complete tumor eradication by standard transurethral resection of bladder tumor (TURBT) being not feasible or unlikely to achieve adequate local control.\n4. Patients who are ineligible or refuse for radical cystectomy, after discussion with the treating team.\n5. At least one measurable or evaluable bladder lesion\u002Fdocumented residual disease suitable for response assessment by cystoscopy, TURBT\u002Fbiopsy, pathology, urine cytology, and urinary tumor DNA (utDNA) testing.\n6. ECOG performance status 0-2.\n7. Adequate organ function, including:\n\n   Hematologic function: Absolute neutrophil count ≥1.5 × 10⁹\u002FL, Platelet count ≥100 × 10⁹\u002FL, Hemoglobin ≥9 g\u002FdL Hepatic function: Total bilirubin ≤1.5 × ULN, AST ≤2.5 × ULN, ALT ≤2.5 × ULN Renal function: Serum creatinine ≤1.5 × ULN or Creatinine clearance ≥60 mL\u002Fmin.\n8. Ability to provide urine samples for utDNA testing and urine cytology during treatment and follow-up.\n\nExclusion Criteria:\n\n1. Muscle-invasive bladder cancer (≥T2), locally advanced unresectable invasive disease beyond NMIBC, or metastatic urothelial carcinoma at baseline.\n2. Histology showing predominant or pure non-urothelial carcinoma of the bladder that, in the investigator's judgment, would make the patient unsuitable for this protocol.\n3. Prior treatment with immune.\n4. Active autoimmune disease or history of autoimmune disease requiring systemic immunosuppressive treatment and considered incompatible with immune checkpoint inhibitor therapy.\n5. Ongoing systemic immunosuppressive therapy exceeding protocol-allowed doses.\n\n7\\. Active uncontrolled infection, including uncontrolled urinary tract infection, that would interfere with study treatment or response assessment.\n\n8\\. Any medical condition that would preclude safe administration of systemic immunotherapy or protocol-required cystoscopy\u002FTURBT\u002Fbiopsy, in the investigator's judgment.\n\n9\\. Concurrent other malignancy. 10. Pregnant or breastfeeding women. 11. Inability to comply with protocol procedures or follow-up.",{"count":134,"type":21},53,[107],"This study evaluates whether urinary tumor DNA (utDNA) testing, together with clinical, pathologic, and radiographic assessment, can help guide treatment discontinuation and active surveillance in patients with unresectable very-high-risk non-muscle-invasive bladder cancer (VHR NMIBC) treated with bladder-sparing systemic immunotherapy.\n\nParticipants receive systemic immune checkpoint inhibitor-based therapy every 3 weeks for an initial 3 cycles. Initial response assessment is performed using transurethral resection of bladder tumor (TURBT) and chest and abdominopelvic computed tomography (CT). Participants without progression to muscle-invasive, regional nodal, or distant metastatic disease then undergo post-TURBT urine cytology and urinary tumor DNA (utDNA) testing. Participants with both negative urine cytology and negative utDNA results receive an additional 3 cycles of systemic immunotherapy.\n\nAfter the additional treatment, participants undergo repeat evaluation using cystoscopy with biopsy, urine cytology, utDNA testing, and chest and abdominopelvic CT. Participants with negative findings on cystoscopic biopsy, urine cytology, and utDNA testing, and without radiographic evidence of nodal or distant metastatic disease, discontinue systemic immunotherapy and enter an active surveillance phase with regular follow-up monitoring. Participants who do not meet these criteria continue further clinical management and follow-up according to institutional practice.\n\nThe study aims to determine whether a shortened duration of systemic immunotherapy guided by integrated molecular, clinical, pathologic, and radiographic response assessment can maintain favorable oncologic outcomes while reducing unnecessary treatment exposure in this high-risk population.",[138,139,115],"Bladder Cancer","Liquid Biopsy","2026-05-21",{"date":142,"type":39},"2026-05-26",{"date":144,"type":39},"2026-03-16",{"date":146,"type":21},"2029-04-01",{"name":45,"class":46},3,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100607367","guiding-value-of-urinary-tumor-dna-testing-in-repeat-transurethral-resection-of-non-muscle-invasive-bladder-cancer-100607367","NCT07187635","Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer","The Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multi-Center Clinical Study (Truce-LB01)","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for the study:\n\n1. Male or female, aged 18 years or older.\n2. Histologically confirmed non-muscle-invasive bladder tumor, with no evidence of muscle-invasive bladder cancer or metastatic disease.\n3. Histologically confirmed urothelial carcinoma of the bladder or bladder tumor with urothelial carcinoma as the predominant component (\\>50%).\n4. At least one of the following conditions:\n\n   1. Incomplete initial transurethral resection of bladder tumor (TURBT) or suspected incomplete resection.\n   2. Absence of detrusor muscle in the initial TURBT pathological specimen (except for low-grade Ta stage tumors or carcinoma in situ \\[CIS\\]).\n   3. T1 stage tumor.\n5. Willingness to provide a 50 mL urine sample between 2-6 weeks after the initial TURBT and prior to re-TURBT.\n6. Willingness to provide tumor tissue samples for pathological examination.\n7. Willingness to undergo genetic testing required for the trial.\n\nExclusion Criteria:\n\n1. Contraindications to transurethral resection of bladder tumor (TURBT).\n2. Concurrent malignancy of the upper urinary tract (ureter or renal pelvis).",{"count":157,"type":21},196,[24],"Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed bladder cancers and is characterized by a high risk of recurrence and progression. Current guidelines recommend that patients with stage T1 NMIBC undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery to remove residual tumor, confirm staging, and obtain additional pathological information. However, the benefits of routine re-TURBT for all high-risk patients remain controversial, as many patients may not have residual disease, while the procedure carries surgical and anesthetic risks, physical and psychological burden, and additional healthcare costs.\n\nUrine tumor DNA (utDNA) refers to DNA fragments shed by tumor cells into urine. It can be detected using molecular assays with high sensitivity and specificity, offering a non-invasive method for bladder cancer diagnosis and surveillance. Previous studies have shown that positive utDNA results after initial TURBT may be associated with residual disease and higher recurrence risk.\n\nThis multicenter, randomized controlled trial aims to evaluate whether utDNA testing can accurately identify NMIBC patients who are most likely to benefit from re-TURBT, thereby guiding the decision to perform the procedure. The goal is to optimize patient selection for re-TURBT, reduce unnecessary surgeries, and improve patient quality of life while maintaining oncologic safety.",[138,139,161],"Repeat Transurethral Resection of Bladder Tumor",[163,164,165],"bladder cancer","liquid biopsy","second transurethral resection of bladder tumor","2026-05-06",{"date":168,"type":39},"2026-05-11",{"date":170,"type":39},"2025-09-28",{"date":172,"type":21},"2027-11-01",{"name":45,"class":46},6,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":195,"locationsCount":196},"100606796","guiding-value-of-urinary-tumor-dna-testing-in-cystoscopy-for-high-riskvery-high-risk-non-muscle-invasive-bladder-cancer-100606796","NCT07180212","Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk\u002FVery High-Risk Non-Muscle-Invasive Bladder Cancer","The Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk\u002FVery High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multicenter Clinical Study (Truce-LB02)","Inclusion Criteria:\n\n1. Male or female participants aged 18 years or older.\n2. Histologically confirmed high-risk or very high-risk non-muscle-invasive urothelial carcinoma (NMIBC) of the bladder, as defined by the EAU 2025 NMIBC guidelines, or bladder tumors in which high-risk\u002Fvery high-risk NMIBC constitutes more than 50% of the pathological composition, diagnosed within the past 2 years, with no evidence of muscle-invasive bladder cancer or metastatic disease.\n3. Prior to enrollment, participants must have undergone either:\n\nA.Second transurethral resection of bladder tumor (re-TURBT), or B.Complete initial TURBT with negative basal margins, peripheral margins, and multiple site biopsies, with pathological specimens including detrusor muscle and showing no residual tumor, and negative urine cytology at 2 weeks post-surgery.\n\nExclusion Criteria:\n\n1.History of upper urinary tract malignancy (ureter or renal pelvis) within the past 5 years or concurrent diagnosis of upper urinary tract urothelial carcinoma.",{"count":183,"type":21},360,[24],"Non-muscle-invasive bladder cancer (NMIBC) is usually treated with surgery to remove the tumor (transurethral resection of bladder tumor, or TURBT), often followed by bladder-instilled medications to reduce the chance of the cancer coming back. Even with this treatment, high-grade NMIBC can return or progress, so patients need regular check-ups, usually with cystoscopy (a camera examination of the bladder) and urine cytology.\n\nCystoscopy is effective but invasive, can cause discomfort, and carries risks such as infection and bleeding. This makes follow-up costly and sometimes burdensome for patients.\n\nThis study is testing whether a urine tumor DNA (utDNA) test - a type of \"liquid biopsy\" that detects cancer-related DNA changes in urine - can help guide the timing of cystoscopy for people with high-risk or very high-risk NMIBC. utDNA testing is non-invasive and has shown high accuracy in detecting bladder cancer, sometimes spotting signs of recurrence earlier than standard methods.\n\nBy combining utDNA testing with cystoscopy, we hope to safely reduce the number of unnecessary cystoscopies without missing cancer recurrences. The study will evaluate whether this approach can make bladder cancer follow-up more comfortable, more precise, and more efficient.",[138,139,187],"Cystoscopy",[163,164,189,190],"cystoscopy","urine tumor DNA",{"date":168,"type":39},{"date":193,"type":39},"2025-09-20",{"date":172,"type":21},{"name":45,"class":46},8,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":206,"conditions":207,"keywords":208,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},"100602981","the-guiding-value-of-liquid-biopsy-based-on-urinary-tumor-dnarna-in-the-second-transurethral-resection-of-high-risk-non-muscle-invasive-bladder-cancer-100602981","NCT07130578","The Guiding Value of Liquid Biopsy Based on Urinary Tumor DNA\u002FRNA in the Second Transurethral Resection of High-risk Non-muscle Invasive Bladder Cancer","Truce-LB00:The Guiding Value of Liquid Biopsy Based on Urinary Tumor DNA\u002FRNA in the Second Transurethral Resection of High-risk Non-muscle Invasive Bladder Cancer: An Open-Label, Observational, Single-Center Clinical Study","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for the study:\n\n1. Male or female, aged 18 years or older.\n2. Histologically confirmed non-muscle-invasive bladder tumor, with no evidence of muscle-invasive bladder cancer or metastatic disease.\n3. Histologically confirmed urothelial carcinoma of the bladder or bladder tumor with urothelial carcinoma as the predominant component (\\>50%).\n4. At least one of the following conditions:\n\n   1. Incomplete initial transurethral resection of bladder tumor (TURBT) or suspected incomplete resection.\n   2. Absence of detrusor muscle in the initial TURBT pathological specimen (except for low-grade Ta stage tumors or carcinoma in situ \\[CIS\\]).\n   3. T1 stage tumor.\n5. Willingness to provide a 50 mL urine sample between 2-6 weeks after the initial TURBT and prior to re-TURBT.\n6. Willingness to provide tumor tissue samples for pathological examination.\n7. Willingness to undergo genetic testing required for the trial.\n8. Voluntarily agrees to participate in the study, has signed informed consent, demonstrates good compliance, and is willing to complete study follow-up.\n\nExclusion Criteria:\n\n1. Contraindications to transurethral resection of bladder tumor (TURBT).\n2. Concurrent malignancy of the upper urinary tract (ureter or renal pelvis).",{"count":205,"type":21},60,"High-risk non-muscle-invasive bladder cancer (NMIBC) carries a substantial risk of residual disease after initial transurethral resection of bladder tumor (TURBT). Current guidelines recommend a second TURBT (re-TURBT) within 2-6 weeks for patients with stage T1 disease to remove residual tumor, confirm staging, and obtain additional pathological information. However, the actual survival benefit of routine re-TURBT for all high-risk patients remains debated, and the procedure may pose surgical risks, increase healthcare costs, and impact patient quality of life.\n\nUrine tumor DNA (utDNA) and urine tumor RNA (utRNA) are molecular biomarkers detectable through non-invasive \"liquid biopsy\" methods. In urothelial carcinoma, tumor-derived nucleic acids can be shed into urine, where they can be detected with high sensitivity and specificity. These biomarkers may help identify patients most likely to harbor residual disease after initial TURBT, and thus most likely to benefit from re-TURBT.\n\nThis prospective, open-label, observational, single-center study aims to evaluate the clinical value of utDNA\u002FutRNA testing in guiding re-TURBT for patients with high-risk NMIBC. The study will assess whether molecular urine testing can improve patient selection for re-TURBT, potentially reducing unnecessary procedures while maintaining oncological safety.",[138,139],[138,139,209,210],"NMIBC","re-TURBT","2026-03-01",{"date":213,"type":39},"2026-03-03",{"date":41,"type":39},{"date":216,"type":21},"2027-05-01",{"name":45,"class":46},2,{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":47},"100626889","using-liquid-biopsy-testing-to-identify-monitor-predict-recurrence-in-urothelial-carcinoma-100626889","NCT07441499","Using Liquid Biopsy Testing to Identify, Monitor, Predict Recurrence in Urothelial Carcinoma","Inclusion Criteria:\n\n* Suspected or histologically confirmed urothelial carcinoma\n\nExclusion Criteria:\n\n* History of or concurrent active malignancy other than urothelial carcinoma",{"count":226,"type":21},300,"Application of Multi-Component Liquid Biopsy (ctDNA, utDNA, Exosomes, and Protein Biomarkers in Blood and Urine) for Auxiliary Diagnosis, Therapeutic Response Evaluation, and Recurrence Monitoring in Urothelial Carcinoma",[229,110,139],"Urothelial Carcinoma (UC)","2026-02-27",{"date":232,"type":39},"2026-03-02",{"date":234,"type":21},"2026-03",{"date":236,"type":21},"2029-01-01",{"name":45,"class":46},{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":47},"100503634","phase-2-efficacy-and-safety-of-tislelizumab-in-combination-with-disitamab-vedotin-as-neoadjuvant-therapy-for-her2-positive-high-risk-upper-tract-urothelial-carcinoma-utuc-100503634","NCT05837806","Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC)","A Single-arm, Open Clinical Trial of Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC)","Inclusion Criteria:\n\n1. Radiographically(CT, MRI or PET-CT, etc.) and histologically confirmed diagnosis of localized HER-2 expressing upper urothelial carcinoma( (cT1-4N0-2M0, HER-2 immunohistochemistry (IHC) ≥ 1+); high risk disease (according to EAU Guidelines for UTUC); planning to receive radical nephroureterectomy (RNU), distal ureterectomy (DU) or ureteroscopic ablation (UA).\n2. Male or female aged 18 years and above;\n3. Expected survival time greater than 12 weeks;\n4. An ECOG status score of 0-2;\n5. Agree to provide specimens of blood, urine, and tissue examination (for detection of MRD, PD-L1 expression, HER2 expression, tumor mutation load, immunohistochemistry, DNA and RNA detection, etc.);\n6. The level of organ function must meet the following requirements:\n\n   * hematological indicators: absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL, platelet count ≥ 80 × 10\\^9\u002FL, hemoglobin ≥ 6.0 g\u002FdL (can be maintained by symptomatic treatment)\n   * hepatic function: total bilirubin ≤ 1.5 times the upper limit of normal, and glutathione and glutamic oxalacetic transaminase ≤ 2.5 times the upper limit of normal;\n   * renal function: GFR ≥ 15 ml\u002Fmin;\n   * Subjects voluntarily joined the study, signed an informed consent form, were compliant, and cooperated with the follow-up.\n\nExclusion Criteria:\n\n1. Live attenuated vaccines, other than COVID-19 vaccine, received within 4 weeks prior to treatment or scheduled to be received during the study period\n2. Active, known or suspected autoimmune disease;\n3. Known history of primary immunodeficiency;\n4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n5. Female patients who are pregnant or breastfeeding\n6. Untreated acute or chronic active hepatitis B or C infection. Patients who are receiving antiviral therapy with monitoring of viral copy number and are eligible for enrollment as determined by the physician on an individual patient basis;\n7. Previous use of immunosuppressive drugs, excluding nasal spray and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg\u002Fday prednisolone or equivalent pharmacologic physiologic doses of other corticosteroids), within 4 weeks prior to initiation of therapy\n8. Known or suspected allergy history to tislelizumab and disitamab vedotin.\n9. With a clear history of active tuberculosis.\n10. Prior PD-1\u002FPD-L1\u002FCTLA-4 antibody or other immunotherapy;\n11. Those who are participating in other clinical studies\n12. Men of reproductive potential or women with the potential to become pregnant who are not using reliable contraception\n13. Uncontrolled co-morbidities, including but not limited to\n\n    * HIV-infected individuals (HIV-positive);\n    * Severe infections that are active or poorly controlled clinically (including patients in the period of neocoronavirus infection)\n    * Evidence of the presence of severe or uncontrolled systemic disease (e.g., severe psychiatric, neurological disease, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic or renal disease, uncontrolled hypertension \\[i.e., defined as greater than or equal to CTCAE grade 2 hypertension despite medication\\]).",{"count":246,"type":21},21,[107],"Neoadjuvant chemotherapy treatment can be used for specific UTUC patients, especially for highly staged and\u002For grade tumors, such as kidneys with potentially decreased renal function after RNU. Neoadjuvant therapy is a series of treatments administered preoperatively for UTUC, mainly chemotherapy, and in recent years, novel therapies of immunotherapy have emerged. Since conventional cisplatin neoadjuvant regimens also require high preoperative renal function, neoadjuvant therapy regimens such as immunotherapy provide more effective and feasible treatments for patients who are intolerant to current cisplatin chemotherapy regimens. The aim of this study was to explore the efficacy and safety of the combination of disitamab vedotin, a human epidermal growth factor receptor-2 (HER-2) targeted ADC, and tislelizumab, a humanised PD-1 ICIs, as neoadjuvant treatment for non-metastatic, high-risk, HER-2 expressing UTUC. In our study, patients enrolled will receive neoadjuvant tislelizumab plus disitamab-vedotin therapy followed by radical nephroureterectomy (RNU), distal ureterectomy (DU) or ureteroscopic ablation (UA) .",[250],"Neoadjuvant Immunotherapy",[252,253,254,255,256,257],"neoadjuvant therapy","UTUC","immunotherapy","upper tract urothelial carcinoma","PD-1","ADC","2025-12-26",{"date":260,"type":39},"2025-12-31",{"date":262,"type":39},"2022-12-30",{"date":264,"type":21},"2027-12-30",{"name":45,"class":46},{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":47},"100610874","phase-2-nephron-sparing-treatment-of-tislelizumab--nab-paclitaxel-for-renal-pelvic-cancer-100610874","NCT07233252","Nephron-sparing Treatment of Tislelizumab + Nab-Paclitaxel for Renal Pelvic Cancer","Nephron-sparing Treatment Combining Tislelizumab and Nab-Paclitaxel for Renal Pelvic Cancer: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U03)","Inclusion Criteria:\n\n1. Males or females aged no less than 18 years old;\n2. Suitable and planned to undergo laser ablation of renal pelvic tumors via ureteroscopy;\n3. The tumor is located in the renal pelvis, diagnosed as upper tract urothelial carcinoma based on ureteroscopic biopsy, urinary cytology, or imaging examinations (CT, MRI, or PET-CT), without lymph node metastasis or distant metastasis, with a clinical stage of T1-2N0M0. Additionally, requiring maximum tumor diameter is less than 3 cm.\n4. Expected survival time of more than 12 weeks;\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;\n6. Agree to provide blood, urine, and tissue samples (for testing PD-L1 expression, HER-2, tumor mutation burden, etc.);\n7. The organ function levels must meet the following requirements:\n\n   Hematological indicators: Absolute neutrophil count ≥1.5×10\\^9\u002FL, platelet count ≥80×10\\^9\u002FL, hemoglobin ≥6.0 g\u002FdL (can be maintained through symptomatic treatment); Liver function: Total bilirubin ≤1.5 times the upper limit of normal, alanine transaminase and aspartate transaminase ≤2.5 times the upper limit of normal; Renal function: Baseline ECT renography indicates a total renal glomerular filtration rate (GFR) ≥15 ml\u002Fmin, with the affected-side GFR \\>10 ml\u002Fmin, excluding the presence of a non-functional kidney (low-level decreasing curve on dynamic renal ECT imaging) on the affected side.\n8. Participants are willing to join the study and be able to sign and comply the protocol.\n\nExclusion Criteria:\n\n1. Concurrent primary malignancies in other sites are excluded, except for those with a history of other malignancies that have been treated and are currently stable.\n2. Confirmed bilateral upper tract urothelial carcinoma (UTUC).\n3. Presence of urothelial carcinoma in ureter or bladder is excluded, except for non-muscle-invasive bladder cancer that can be completely resected via transurethral resection of bladder tumor (TURBT).\n4. Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;\n5. Active, known or suspected history of autoimmune disease;\n6. Known history of primary immunodeficiency;\n7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n8. Pregnant or breastfeeding female patients;\n9. Untreated acute or chronic active Hepatitis B or Hepatitis C infection. Patients receiving antiviral therapy may be eligible if viral load is under monitored, at the discretion of the physician based on the patient's individual condition;\n10. Receiving immunosuppressive medication within 4 weeks prior to starting treatment, except nasal, inhaled, topical steroids, or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg\u002Fday of prednisone or equivalent dose of other corticosteroids);\n11. Known or suspected allergy to Tislelizumab or Nab-Paclitaxel;\n12. Active tuberculosis;\n13. Previous treatment with PD-1\u002FPD-L1\u002FCTLA-4 immune checkpoint inhibitors or other immunotherapies;\n14. Participation in another clinical study;\n15. Fertile men or women without effective contraception;\n16. Uncontrolled concurrent illness, including but not limited to:\n\n(1)HIV infection (HIV antibodies positive); (2)Uncontrolled severe infection; (3)Uncontrolled systemic disease (such as severe psychiatric, neurological disorders, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver, or kidney disease, uncontrolled hypertension \\[i.e., hypertension of CTCAE grade 2 or higher despite treatment\\]); (4)Active hemorrhage or newly developed thrombotic disease. (5)Renal failure with CKD grade 5 and undergoing dialysis treatment.",{"count":274,"type":21},35,[107],"This study is designed as an open-label, single-arm, single-center, phase II clinical trial, aiming to evaluate the efficacy of nephron-sparing treatment combining Tislelizumab and Nab-Paclitaxel for HER-2 expressing renal pelvic cancer (RPC) . Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo evaluation. Patients who achieve all of the following criteria of \"well response and tolerance\" will receive further maintenance treatment:\n\n(1)The patient achieves a complete response (CR) or partial response (PR) according to the RECIST 1.1 criteria, indicating that the tumor is well-controlled. (2) If the patient has residual lesions, it should be confirmed by the clinical physician that these lesions can be eliminated through laser ablation via ureteroscopy. (3)The patient has not experienced any treatment-related adverse events (TRAEs) that warrant discontinuation of therapy during systemic treatment. (4)The patient is willing to undergo further maintenance therapy. If the patient meets all the criteria above, ureteroscopic biopsy should be performed. If residual lesions are detected under the ureteroscope, endoscopic intervention (e.g., laser ablation, cryoablation) should be carried out simultaneously to eliminate these residual lesions. Patients who meet the above criteria will proceed with no less than 2 cycles of maintenance systemic therapy (Tislelizumab + Nab-Paclitaxel). Patients who do not meet the criteria will be excluded from the study and are recommended to undergo salvage radical nephroureterectomy (RNU) as soon as possible. One-year Nephron-Sparing Survival (1 year-NSS): Defined as the absence of surgical indications for nephrectomy due to progression or recurrence of upper urinary tract urothelial carcinoma, distant metastasis caused by the primary upper urinary tract tumor, or death from any cause within 1 year from the initiation of treatment. Treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.",[278,279,280,281,282],"Renal Pelvic Carcinoma","Tislelizumab","PD-1 Inhibitor","Kidney-sparing","Nab-paclitaxel","2025-11-16",{"date":285,"type":39},"2025-11-18",{"date":287,"type":21},"2025-11-25",{"date":289,"type":21},"2030-12-30",{"name":45,"class":46},{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":298,"minAge":18,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":22,"phases":301,"briefSummary":302,"conditions":303,"keywords":307,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":47},"100606763","phase-2-sacituzumab-tirumotecan-in-combination-with-tagitanlimab-in-the-treatment-of-aggressive-variant-prostate-cancer-avpc-and-neuroendocrine-prostate-cancer-nepc-100606763","NCT07179783","Sacituzumab Tirumotecan in Combination With Tagitanlimab in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC)","Phase II Study of the Combination of Sacituzumab Tirumotecan(SKB264)and Tagitanlimab (KL-A167) in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC)","Inclusion Criteria:\n\n1. Age at the time of signing the informed consent form is ≥ 18 years old;\n2. AVPC or NEPC diagnosed based on recent histological and\u002For clinical criteria;\n3. Having received one or two second-generation anti androgen therapies in the past, previous use of docetaxel for castration resistant prostate cancer (CRPC) is allowed, and the use of other chemotherapy is not allowed;\n4. The progression of prostate cancer in the subjects within 6 months prior to screening shall be determined by the researcher through one of the following methods:\n\n   PSA is evaluated by local laboratories, and PSA progression is defined as at least two increases in PSA levels at intervals of ≥ 1 week, with a screening PSA value of ≥ 2 ng\u002Fml.\n\n   • Soft tissue imaging disease progression determined based on PCWG modified RECIST 1.1 or RECIST 1.1 criteria, regardless of PSA progression.\n\n   The imaging disease progression of bones is defined as the appearance of two or more new bone lesions in bone scans, regardless of PSA progression.\n5. Subjects who have not undergone past surgery must be using and voluntarily continue to use luteinizing hormone releasing hormone (LHRH) agonists throughout the entire study treatment period;\n6. According to RECIST v1.1, there should be at least one measurable lesion, and previously irradiated lesions should not be selected as target lesions; Subjects with only skin or bone lesions are not eligible for inclusion;\n7. Within 7 days prior to administration, the physical fitness status score of the Eastern Cooperative Oncology Group (ECOG) in the United States was 0 or 1;\n8. Expected survival period ≥ 12 weeks;\n9. Having sufficient organ and bone marrow function (without receiving blood transfusion, recombinant human thrombopoietin or colony-stimulating factor therapy within 2 weeks prior to administration), defined as follows:\n\n   1. Blood routine: neutrophil count (NEUT #) ≥ 1.5 × 109\u002FL; platelet count (PLT) ≥ 100 × 109\u002FL; hemoglobin ≥ 90 g\u002FL;\n   2. Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; For subjects with liver metastasis at baseline, ALT and AST should be ≤ 5 × ULN; Albumin ≥ 30g\u002FL; Total bilirubin (TBIL) ≤ 1.5 × ULN;\n   3. Renal function: creatinine clearance rate ≥ 50 ml\u002Fmin (calculated using the standard Cockcroft Gault formula);\n   4. Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤ 1.5 × ULN;\n10. For subjects whose partners have fertility potential, they must agree to take effective medical contraceptive measures within 6 months from the signing of the informed consent form until the last administration (see Annex 2 for details);\n11. The subjects voluntarily joined this study, signed an informed consent form, and were able to comply with the visit and related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Previously received any of the following treatments (including in the context of adjuvant or neoadjuvant therapy):\n\n   1. Targeted treatment of TROP2;\n   2. Any drug therapy containing targeted topoisomerase I, including antibody conjugated drug (ADC) therapy;\n   3. Immune checkpoint inhibitors (such as anti-PD-1\u002FL1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any other treatment targeting the tumor immune mechanism;\n2. Those who require the use of strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first administration and during the study period (strong inhibitors or inducers of CYP3A4 are not allowed in this study, and representative drugs of CYP3A4 strong inhibitors or inducers are listed in Appendix 7); All subjects must avoid the concurrent use of any drugs, herbal supplements, and\u002For intake of such foods known to induce CYP3A4 as much as possible;\n3. Subjects with central nervous system (CNS) metastases known to have meningeal metastases, brainstem metastases, spinal cord metastases and\u002For compression, active or untreated conditions. For subjects with brain metastases who have received local treatment in the past, if they have been clinically stable for at least 4 weeks before medication and have not required the use of glucocorticoids or anticonvulsants for at least 14 days, they are allowed to be enrolled;\n4. Suffering from other malignant tumors within 3 years before administration (excluding tumors that have been cured through local treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.);\n5. There are any of the following cardiovascular diseases or cardiovascular risk factors:\n\n   1. Within 6 months prior to administration, if there is a myocardial infarction, unstable angina, acute or persistent myocardial ischemia, grade 3 or 4 heart failure (according to the New York Heart Association (NYHA) classification), symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other serious cardiovascular and cerebrovascular diseases;\n   2. Previous history of myocardial diseases such as myocarditis, primary cardiomyopathy, and specific cardiomyopathy;\n   3. Any deep vein thrombosis (if stabilized for ≥ 2 weeks with low molecular weight heparin or similar efficacy drugs), peripheral arterial thromboembolic events, pulmonary embolism, or other serious thromboembolic events within 3 months prior to administration;\n   4. Major vascular diseases that may endanger life or require surgery within 6 months prior to administration, such as aortic aneurysm, aortic dissection aneurysm, etc;\n6. According to researchers' assessment, uncontrolled systemic diseases:\n\n   1. Poor control of diabetes (fasting blood glucose ≥ 10 mmol\u002FL for two consecutive times);\n   2. Poor control of hypertension (systolic blood pressure\\>160 mmHg and\u002For diastolic blood pressure\\>100 mmHg);\n   3. Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage (\\>once per week);\n7. History of (non infectious) interstitial lung disease (ILD) or non infectious pneumonia requiring steroid treatment, current ILD or non infectious pneumonia, or suspected ILD or non infectious pneumonia that cannot be excluded by imaging examination during screening;\n8. Clinical severe lung damage caused by concurrent lung diseases, including but not limited to any underlying lung disease (such as pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc. within 3 months before administration) or any autoimmune, connective tissue, or inflammatory disease that may affect the lungs (i.e. rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or previous total pneumonectomy;\n9. Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess, or acute gastrointestinal bleeding;\n10. Individuals with bleeding tendencies such as acute gastrointestinal bleeding, persistent bleeding disorders, or coagulation dysfunction;\n11. The toxicity of previous anti-tumor treatments has not yet recovered to ≤ level 1 (evaluated based on NCI CTCAE v5.0) or the levels specified in the inclusion and exclusion criteria (excluding toxicity judged by researchers to be of low safety risk such as hair loss and fatigue).\n12. Suffering from active autoimmune diseases that require systemic treatment within the past two years (including but not limited to: autoimmune hepatitis, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, etc.), systemic treatment includes drugs to improve the condition, immunosuppressants, systemic corticosteroid administration (\\>10 mg\u002Fday prednisone or equivalent drugs), etc. Hormone replacement therapy, such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, is not considered a systemic treatment; Subjects who received systemic corticosteroid treatment with\\>10 mg\u002Fday prednisone or other immunosuppressive drugs within 2 weeks prior to administration.\n13. Known active pulmonary tuberculosis. Subjects suspected of having active pulmonary tuberculosis need to undergo clinical examination for exclusion;\n14. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n15. Accompanied by ≥ grade 2 peripheral neuropathy;\n16. Active hepatitis B \\[hepatitis B surface antigen (HBsAg) is positive, and HBV-DNA detection is required; HBV-DNA ≥ 500 IU\u002FmL or higher than the lower limit of detection, whichever is higher\\] or hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower limit of detection). Note: HBsAg positive subjects are required to receive anti hepatitis B virus treatment during the study treatment;\n17. Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection;\n18. Known allergies to the investigational drug or any of its components, and a history of severe hypersensitivity reactions to other biological agents;\n19. Individuals who have undergone major surgery within 4 weeks prior to administration or are expected to undergo major surgery during the study period;\n20. Serious infection occurred within 4 weeks prior to administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; Within 2 weeks prior to administration, there is an active infection that requires systemic anti infective treatment;\n21. A recorded history of severe dry eye syndrome, severe meibomian gland disease and\u002For meibomian inflammation, or corneal diseases that hinder delayed corneal healing;\n22. Have received non-specific immunomodulation therapy (including but not limited to interferon and IL-2), traditional Chinese patent medicines and simple preparations preparations with approved anti-tumor indications, etc. within 2 weeks before administration;\n23. Received a live vaccine within 30 days prior to administration, or planned to receive a live vaccine during the study period; During the screening process before administration, the condition rapidly deteriorates, such as significant changes in physical fitness status;\n\n25\\) Suffering from local or systemic diseases caused by non malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risks and\u002For uncertainty in survival evaluation, such as tumor like leukemia reactions, cachexia manifestations, etc; 26) Any condition that the researcher deems to interfere with the evaluation of the investigational drug, the safety of the subjects, or the interpretation of the research results, or any other condition that the researcher deems unsuitable for participation in this study.","MALE",{"count":300,"type":21},28,[107],"This study is a prospective, single arm II clinical trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (SKB264) and Tagitanlimab (KL-A167) in the treatment of AVPC (aggressive variant prostate cancer) and NEPC (neuroendocrine prostate cancer).",[304,305,306],"Prostate Cancer (Adenocarcinoma)","Prostate Cancer Metastatic Castration-Resistant","Prostate Adenocarcinoma With Neuroendocrine Differentiation",[308,309,310,311],"NEPC","AVPC","TROP2","PD-L1","2025-09-16",{"date":314,"type":39},"2025-09-18",{"date":316,"type":21},"2025-09-22",{"date":318,"type":21},"2027-07-31",{"name":45,"class":46},{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":22,"phases":329,"briefSummary":330,"conditions":331,"keywords":332,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":341,"locationsCount":47},"100606194","phase-2-preoperative-therapy-of-super-selective-tumor-artery-embolization-combined-with-toripalimab-and-axitinib-in-advanced-rcc-100606194","NCT07172386","Preoperative Therapy of Super-selective Tumor Artery Embolization Combined With Toripalimab and Axitinib in Advanced RCC","A Study on the Safety and Efficacy of Super-selective Tumour Arterial Embolisation in Combination With Toripalimab and Axitinib as a Preoperative Treatment for Advanced Renal Cell Carcinoma","Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* Age ≥ 18 years\n* Patients with pathologically and radiographically confirmed renal cell carcinoma:\n\n  * cT2N0M0 with Grade 4 or sarcomatoid feature;\n  * cT3-4N0M0;\n  * cTanyN1M0;\n  * M1 that can be returned to M0 through local therapy\n* Preoperative imaging evaluation can be performed radical excision or tumor reduction surgery\n* There are no suspected brain metastases\n* The presence of measurable lesions was assessed according to RECISTv1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n* Organ function level must meet the following requirements: Hematological indexes: neutrophil count \\>= 1.5x10\\^9\u002FL, platelet count \\>= 100x10\\^9\u002FL, hemoglobin \\>= 9.0 g\u002Fdl (can be maintained by blood transfusion); Liver function: total bilirubin \\\u003C=1.5 ULN, alanine aminotransferase and aspartate aminotransferase \\\u003C=1.5 ULN\n* Non-surgically sterilized or reproductive-age female patients must use a medically approved contraceptive method (such as an intrauterine device, oral contraceptives, or condoms) during the study treatment period and for 3 months after its completion; Female patients who are not surgically sterilized or are of childbearing potential must have a negative serum or urine HCG test within 7 days prior to study enrollment and must not be lactating. Male patients who are not surgically sterilized or are of childbearing potential must agree to use one medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the study treatment period ends.\n* The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up\n\nExclusion Criteria:\n\n* Prior receipt of radiotherapy, chemotherapy, long-term or high-dose corticosteroid therapy, surgery, or molecular targeted therapy\n* Subjects with a history of or concurrent other malignancies (except those controllable and not affecting 2-year survival)\n* Prior treatment with other PD-1\u002FPD-L1 therapies; Known history of allergy to macromolecular protein preparations or any known PD-1 component\n* Active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or childhood asthma that has achieved complete remission without requiring any intervention in adulthood may be included; subjects requiring medical intervention with bronchodilators for asthma are excluded);\n* Subjects currently using immunosuppressive agents for immunosuppression purposes and continuing such use within 2 weeks prior to enrollment\n* Uncontrolled cardiac clinical symptoms or diseases, such as:\n\n  * New York Heart Association (NYHA) Class II or higher heart failure;\n  * Unstable angina;\n  * Myocardial infarction within the past year;\n  * Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention\n* Coagulation abnormalities (PT \\> 16s, APTT \\> 43s, TT \\> 21s, Fbg \\> 2g\u002FL) with bleeding tendency or currently receiving thrombolytic or anticoagulant therapy;\n* Active gastrointestinal bleeding within 3 months prior to first dose due to esophageal varices, active gastric or duodenal ulcer, ulcerative colitis, portal hypertension, or unresected tumors; or other conditions judged by the investigator to potentially cause gastrointestinal bleeding or perforation\n* History or current presence of major bleeding (≥30 mL within 3 months), hemoptysis (≥5 mL fresh blood within 4 weeks), or thromboembolic events (including stroke and\u002For transient ischemic attack) within 12 months\n* Active infection or unexplained fever \\>38.5°C occurring during screening or prior to first dose\n* History of abdominal fistula, gastrointestinal perforation, or abdominal abscess within 4 weeks prior to first dose\n* Objective evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe pulmonary impairment\n* Subjects with congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (transaminase levels not meeting inclusion criteria; for hepatitis B: HBV DNA ≥10⁴\u002Fml; for hepatitis C: HCV RNA ≥10³\u002Fml); chronic hepatitis B virus carriers with HBV DNA ≥2000 IU\u002Fml (≥10⁴ copies\u002Fml) must concurrently receive antiviral therapy during the study to be eligible for enrollment\n* Subjects currently participating in other clinical studies or those who completed a prior clinical study within the past month; subjects may receive other systemic antitumor therapies during the study period\n* Administration of live vaccines within 4 weeks prior to study drug initiation or during the study period\n* Known history of psychiatric drug abuse, alcoholism, or substance abuse;\n* Inability or refusal to bear out-of-pocket costs for examinations and treatments\n* The investigator deems the subject should be excluded from this study, such as when the investigator determines the subject has other factors that may necessitate premature termination of the study, including: other serious illnesses (including psychiatric disorders) requiring concomitant treatment, severe laboratory abnormalities, or family\u002Fsocial factors that may compromise subject safety or interfere with data\u002Fsample collection.",{"count":328,"type":21},40,[107],"This is a phase II study to determine the efficacy and safety of Super-selective tumor artery embolization combined with toripalimab and axitinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment plan is beneficial to the patient's operation. Patients will undergo super-selective embolization of the feeding arteries to the renal tumour one week prior to drug therapy, followed by toripalimab administered every three weeks for three to four consecutive cycles combined with axitinib administered for four consecutive cycles in the preoperative and patients need to continue taking the drug for a year after surgery",[83],[86,333,334,335],"Axitinib","Super-selective renal artery embolization","Advanced Renal Cell Carcinoma","2025-09-13",{"date":312,"type":39},{"date":339,"type":39},"2025-07-31",{"date":318,"type":21},{"name":45,"class":46},{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":352,"conditions":353,"keywords":356,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":4},"100606193","safety-and-effectiveness-of-antegrade-flexible-ureteroscopy-assisted-percutaneous-nephrolithotomy-for-staghorn-calculi-100606193","NCT07172373","Safety and Effectiveness of Antegrade Flexible Ureteroscopy-Assisted Percutaneous Nephrolithotomy for Staghorn Calculi","Safety and Efficacy of Antegrade Flexible Ureteroscopy-Assisted Percutaneous Nephrolithotomy for Staghorn Calculi: A Prospective Multicenter Clinical Study","Inclusion Criteria:\n\nStaghorn calculi confirmed by non-contrast CT of the urinary system; Age ≥18 years; General condition suitable for surgical treatment; Ability to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\nSolitary kidney or congenital anomalies (such as horseshoe kidney or ectopic kidney); Patients with severe preoperative pyelonephritis; Patients with psychiatric disorders or unwilling to cooperate; Patients with uncontrolled diabetes or hypertension who cannot tolerate surgery; Patients with coagulation disorders; Patients deemed unsuitable for participation in this trial by the investigator.",{"count":350,"type":21},420,[24],"Objective This study aims to evaluate the safety and efficacy of antegrade flexible ureteroscopy-assisted PCNL for the treatment of staghorn calculi, compared with standard PCNL.\n\nMethods This prospective, multicenter, randomized controlled trial plans to enroll 420 patients with staghorn calculi, randomly assigned into two groups: the experimental group (antegrade flexible ureteroscopy-assisted PCNL, n=210) and the control group (standard PCNL, n=210). The primary endpoint is stone-free rate (defined as no residual fragment ≥2 mm on postoperative CT). Secondary endpoints include operative time, number of percutaneous tracts, rate of secondary procedures, hemoglobin decrease, postoperative complications (Clavien-Dindo classification), and length of hospital stay. All patients will undergo CT evaluation on postoperative day 2. Subgroup analysis will be performed according to the number of stone branches (≥5 vs \\\u003C5).",[354,355],"Urolithiasis","Renal Stones",[357,358,359,360],"Percutaneous nephrolithotomy","Antegrade flexible ureteroscopy","Staghorn calculi","Stone branch number","2025-09-12",{"date":363,"type":39},"2025-09-15",{"date":365,"type":21},"2025-10-01",{"date":367,"type":21},"2026-04-30",{"name":45,"class":46},{"id":370,"slug":371,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":22,"phases":378,"briefSummary":379,"conditions":380,"keywords":382,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":47},"100606034","phase-2-phase-ii-trial-of-tunlametinib-in-patients-with-nras-mutant-non-melanoma-refractory-solid-tumors-100606034","NCT07170293","Phase II Trial of Tunlametinib in Patients With NRAS Mutant Non-melanoma Refractory Solid Tumors","An Exploratory, Prospective, Single Arm, Open Label, Single Center, Basket, Phase II Clinical Study of Tunlametinib (HL-085) in Patients With NRAS Mutant Non-melanoma Refractory Solid Tumors","Exclusion Criteria:\n\n1. Have had other malignant tumors in the past 2 years (excluding tumors with low malignancy such as basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, etc. that have undergone radical treatment) or have been diagnosed with melanoma;\n2. Moderate or greater amounts of pleural effusion, pericardial effusion, and peritoneal effusion that cannot be controlled by researchers (including but not limited to those that require repeated drainage and have clinical symptoms);\n3. Prior to initial administration of anti-tumor therapy: Within 4 weeks or 5 drug half lives (whichever is shorter) prior to administration, anti-tumor drugs (including cytotoxic therapy, targeted therapy, antibody therapy, immunotherapy, etc.) were administered; Received nitrosourea or mitomycin C treatment within 6 weeks prior to administration; Received palliative radiotherapy within 2 weeks prior to administration; Received other anti-tumor treatments such as radical radiotherapy and electric field therapy within 4 weeks before administration; Received traditional Chinese medicine treatment for anti-tumor indications within 2 weeks before administration;\n4. Toxic reactions of previous anti-tumor treatments that have not yet improved to CTCAE ≤ 1 (excluding hair loss, skin toxicity, or other toxicity that researchers consider to be of no safety risk);\n5. Any situation that affects the ingestion of drugs and seriously affects the absorption or pharmacokinetic parameters of the investigational drug, including but not limited to active gastrointestinal ulcers, long-term gastroesophageal reflux disease (GERD), etc;\n6. Severe or uncontrollable heart diseases that require treatment, including any of the following conditions (including but not limited to): ECG QT interval prolongation corrected according to the Fridericia formula, male QTcF\\>450milliseconds or female QTcF\\>470milliseconds; Various clinically significant arrhythmias, including but not limited to second degree type II conduction block, third degree conduction block, etc; Cardiac ultrasound indicates a left ventricular ejection fraction (LVEF) of less than 50%; Within 6 months before the first medication, there is myocardial infarction, unstable angina, NYHA class III or IV heart failure; An arterial\u002Fvenous thrombosis event occurred within 6 months prior to the first medication, and the risk was deemed uncontrollable, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Or known familial and\u002For acquired thrombophilia tendencies, such as genetic or acquired defects in anticoagulant proteins, coagulation factors, fibrinolytic proteins, etc; 8 Severe or uncontrolled diabetes (fasting blood glucose ≥ 10mmol\u002FL under the standardized blood pressure reduction program), hypertension (poorly controlled under the standardized blood pressure reduction program, systolic blood pressure ≥ 160mmHg and\u002For diastolic blood pressure ≥ 100mmHg), epilepsy, chronic obstructive pulmonary disease, interstitial pneumonia, pulmonary fibrosis, Parkinson's disease, active bleeding, systemic active infection;\n\n9\\. Any unstable systemic disease (such as severe liver, kidney, or metabolic diseases such as cirrhosis, renal failure, and uremia); Within 14 days or 5 half lives prior to the first administration, have used CYP3A4 potent and moderate inhibitors and inducers, CYP3A4, CYP2C9, and CYP2C8 sensitive substrates, OATP1B1, OATP1B3, OAT1, OAT3, P-gp, and BCRP substrates (see Appendix 8 for details); 11. Cognitive impairment, history of mental illness, other uncontrolled comorbidities, alcohol dependence, hormone dependence, or drug abuse; Received autologous or allogeneic organ or stem cell transplantation surgery within 3 months prior to the first use of medication; Having undergone major surgery or severe trauma within 4 weeks prior to the first use of medication (excluding biopsy due to sample collection); 13. History of immunodeficiency, including HIV antibody positivity or other acquired or congenital immunodeficiency diseases; 14. There are serious eye diseases (excluding cataracts, etc.), and they have not yet recovered and improved to ≤ level 1; The following serological status reflecting active hepatitis B or hepatitis C infection exists: hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV DNA\\>1000 copies\u002FmL; hepatitis C virus antibody positive, and HCV RNA\\>the upper limit of normal value; 16 cases of active syphilis infection; 17 is known to be severely allergic to the active ingredients or any excipients of the investigational drug; Participated in other clinical trials within 4 weeks prior to the first administration of medication; 19. Patients with positive pregnancy test results or breastfeeding during the screening period; 20 researchers believe that it is not suitable to participate in this study. According to the researchers' assessment, the patient may have other factors that could affect the research results or lead to the forced termination of this study, such as alcohol abuse, drug abuse, other serious illnesses (including mental illnesses) that require concurrent treatment, serious laboratory test abnormalities, and family or social factors that could affect the patient's safety.",{"count":377,"type":21},15,[107],"This study is a single cohort, open label exploratory clinical trial aimed at observing and evaluating the efficacy and safety of Tunlametinib (HL-085) in the treatment of refractory solid tumors with advanced metastatic non melanoma. It is expected that the ORR of Tunlametinib (HL-085) treatment can reach 20%. According to the literature results, the experimental group rate is 0.2 and the target value rate is 0.02. If the bilateral alpha is 0.05 and the beta is 0.2, the sample size is calculated as 12 cases in the experimental group. Considering a 20% dropout rate, a total of 15 cases are required.",[381],"Solid Cancers",[383,384,385],"NRAS","Tunlametinib","MEK","2025-09-11",{"date":361,"type":39},{"date":389,"type":21},"2027-08-31",{"date":391,"type":21},"2027-09-30",{"name":45,"class":46},{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":22,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":411,"locationsCount":47},"100602638","phase-2-neoadjuvant-tislelizumab-in-combination-with-nab-paclitaxel-for-utuc-100602638","NCT07126119","Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC","Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for Upper Tract Urothelial Carcinoma: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U02)","Inclusion Criteria:\n\n1. Males or females aged no less than 18 years old;\n2. UTUC indicated by ureteroscopic biopsy and imageological examination (including CT, MRI, or PET-CT), without evidences of metastasis in chest CT scan and abdominal CT scan (T1-4N0-2M0); High risk disease confirmed in accordance with the EAU guidelines.\n3. Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component \\>50% in the specimen from ureteroscopic biopsy;\n4. Suitable and planned to receive RNU.\n5. Expected survival time of more than 12 weeks;\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;\n\n6.Agree to provide blood, urine, and tissue samples (for testing PD-L1 expression, HER-2, tumor mutation burden, etc.); 7.The organ function levels must meet the following requirements: Hematological indicators: Absolute neutrophil count ≥1.5×10\\^9\u002FL, platelet count ≥80×10\\^9\u002FL, hemoglobin ≥6.0 g\u002FdL (can be maintained through symptomatic treatment); Liver function: Total bilirubin ≤1.5 times the upper limit of normal, alanine transaminase and aspartate transaminase ≤2.5 times the upper limit of normal; Renal function: Baseline ECT renography indicates a total renal glomerular filtration rate (GFR) ≥15 ml\u002Fmin.\n\n8.Participants are willing to join the study and be able to sign and comply the protocol.\n\nExclusion Criteria:\n\n1. Concurrent primary malignancies in other sites are excluded, except for those with a history of other malignancies that have been treated and are currently stable.\n2. Confirmed bilateral upper tract urothelial carcinoma (UTUC).\n3. Presence of urothelial carcinoma in bladder is excluded, except for non-muscle-invasive bladder cancer that can be completely resected via transurethral resection of bladder tumor (TURBT).\n4. Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;\n5. Active, known or suspected history of autoimmune disease;\n6. Known history of primary immunodeficiency;\n7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n8. Pregnant or breastfeeding female patients;\n9. Untreated acute or chronic active Hepatitis B or Hepatitis C infection. Patients receiving antiviral therapy may be eligible if viral load is under monitored, at the discretion of the physician based on the patient's individual condition;\n10. Receiving immunosuppressive medication within 4 weeks prior to starting treatment, except nasal, inhaled, topical steroids, or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg\u002Fday of prednisone or equivalent dose of other corticosteroids);\n11. Known or suspected allergy to Tislelizumab or Nab-Paclitaxel;\n12. Active tuberculosis;\n13. Previous treatment with PD-1\u002FPD-L1\u002FCTLA-4 immune checkpoint inhibitors or other immunotherapies;\n14. Participation in another clinical study;\n15. Fertile men or women without effective contraception;\n16. Uncontrolled concurrent illness, including but not limited to:\n\n(1)HIV infection (HIV antibodies positive); (2)Uncontrolled severe infection; (3)Uncontrolled systemic disease (such as severe psychiatric, neurological disorders, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver, or kidney disease, uncontrolled hypertension \\[i.e., hypertension of CTCAE grade 2 or higher despite treatment\\]); (4)Active hemorrhage or newly developed thrombotic disease. (5)Renal failure with CKD grade 5 and undergoing dialysis treatment.",{"count":274,"type":21},[107],"This study is designed as an open-label, single-arm, single center, phase II clinical trial, aiming to evaluate the efficacy of neoadjuvant Tislelizumab combined with Nab-Paclitaxel for patients with non-metastatic upper tract urothelial carcinoma (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo radical nephroureterectomy (RNU). The assessment of efficacy is based on the histology of specimen from RNU, and treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.",[27,404,280,282],"Neoadjuvant Therapy","2025-08-15",{"date":407,"type":39},"2025-08-17",{"date":409,"type":39},"2025-07-05",{"date":289,"type":21},{"name":45,"class":46},{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":427,"leadSponsor":428,"locationsCount":47},"100602594","phase-2-neoadjuvant-tislelizumab--nab-paclitaxel-followed-by-distal-ureterectomy-for-ureteral-cancer-100602594","NCT07125547","Neoadjuvant Tislelizumab + Nab-Paclitaxel Followed by Distal Ureterectomy for Ureteral Cancer","Neoadjuvant Tislelizumab Combined With Nab-Paclitaxel Followed by Distal Ureterectomy for Ureteral Cancer: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U01)","Inclusion Criteria:\n\n1. Males or females aged no less than 18 years old;\n2. Ureteral cancer indicated by ureteroscopic biopsy and imageological examination (including CT, MRI, or PET-CT), without evidences of metastasis in chest CT scan and abdominal CT scan (T1-4N0-2M0).\n3. Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component \\>50% in the specimen from ureteroscopic biopsy;\n4. Suitable and planned to receive distal ureterectomy (including distal ureterectomy + partial cystectomy + ipsilateral pelvic lymph node dissection + psoas hitch procedure + ureteral reimplantation into the bladder).\n5. Expected survival time of more than 12 weeks;\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;\n\n6.Agree to provide blood, urine, and tissue samples (for testing PD-L1 expression, tumor mutation burden, etc.); 7.The organ function levels must meet the following requirements: Hematological indicators: Absolute neutrophil count ≥1.5×10\\^9\u002FL, platelet count ≥80×10\\^9\u002FL, hemoglobin ≥6.0 g\u002FdL (can be maintained through symptomatic treatment); Liver function: Total bilirubin ≤1.5 times the upper limit of normal, alanine transaminase and aspartate transaminase ≤2.5 times the upper limit of normal; Renal function: Baseline ECT renography indicates a total renal glomerular filtration rate (GFR) ≥15 ml\u002Fmin, with the affected-side GFR \\>10 ml\u002Fmin, excluding the presence of a non-functional kidney (low-level decreasing curve on dynamic renal ECT imaging) on the affected side.\n\n8.Participants are willing to join the study and be able to sign and comply the protocol.\n\nExclusion Criteria:\n\n1. Concurrent primary malignancies in other sites are excluded, except for those with a history of other malignancies that have been treated and are currently stable.\n2. Confirmed bilateral upper tract urothelial carcinoma (UTUC).\n3. Presence of urothelial carcinoma in the renal pelvis or bladder is excluded, except for non-muscle-invasive bladder cancer that can be completely resected via transurethral resection of bladder tumor (TURBT).\n4. Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;\n5. Active, known or suspected history of autoimmune disease;\n6. Known history of primary immunodeficiency;\n7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n8. Pregnant or breastfeeding female patients;\n9. Untreated acute or chronic active Hepatitis B or Hepatitis C infection. Patients receiving antiviral therapy may be eligible if viral load is under monitored, at the discretion of the physician based on the patient's individual condition;\n10. Receiving immunosuppressive medication within 4 weeks prior to starting treatment, except nasal, inhaled, topical steroids, or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg\u002Fday of prednisone or equivalent dose of other corticosteroids);\n11. Known or suspected allergy to Tislelizumab or Nab-Paclitaxel;\n12. Active tuberculosis;\n13. Previous treatment with PD-1\u002FPD-L1\u002FCTLA-4 immune checkpoint inhibitors or other immunotherapies;\n14. Participation in another clinical study;\n15. Fertile men or women without effective contraception;\n16. Uncontrolled concurrent illness, including but not limited to:\n\n(1)HIV infection (HIV antibodies positive); (2)Uncontrolled severe infection; (3)Uncontrolled systemic disease (such as severe psychiatric, neurological disorders, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver, or kidney disease, uncontrolled hypertension \\[i.e., hypertension of CTCAE grade 2 or higher despite treatment\\]); (4)Active hemorrhage or newly developed thrombotic disease. (5)Renal failure with CKD grade 5 and undergoing dialysis treatment.",{"count":274,"type":21},[107],"This study is designed as an open-label, single-arm, single-center, phase II clinical trial, aiming to evaluate the efficacy and safety of neoadjuvant Tislelizumab combined with Nab-Paclitaxel followed by distal ureterectomy for patients with non-metastatic ureteral cancer (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo distal ureterectomy (DU). The assessment of efficacy is based on the histology of specimen from DU, and treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.",[423,404,280,281,279,282],"Ureteral Cancer","2025-08-09",{"date":405,"type":39},{"date":409,"type":39},{"date":289,"type":21},{"name":45,"class":46},{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":22,"phases":438,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":451,"locationsCount":47},"100584928","phase-1-study-of-pazopanib-combined-with-palbociclib-for-refractory-solid-tumors-with-co-amplified-in-the-11q13fgf3419ccnd1-100584928","NCT06895733","Study of Pazopanib Combined With Palbociclib for Refractory Solid Tumors With Co-amplified in the 11q13(FGF3\u002F4\u002F19\u002FCCND1)","A Multi Cohort Phase IB\u002FII Clinical Study of Pazopanib Combined With Palbociclib for Third Line and Beyond Treatment of Refractory Solid Tumors With Co-amplified in the 11q13(FGF3\u002F4\u002F19\u002FCCND1)","Inclusion Criteria:\n\n1. Voluntarily join this study and sign an informed consent form;\n2. ≥ 18 years old;\n3. Patients with metastatic solid tumors diagnosed by histology or cytology; Queue 1:11q13 co amplified or FGFR1\u002FFGFR2 amplified urothelial carcinoma Queue 2: Head and neck squamous cell carcinoma co amplified in 11q13 region Queue 3:11q13 co amplified other solid tumors\n4. Disease progression or intolerable toxicity confirmed by imaging during or after treatment with at least two standard treatment regimens in the past;\n5. According to RECIST 1.1, there must be at least one measurable lesion;\n6. Can swallow pills normally;\n7. ECOG score: 0-2;\n8. Expected survival period ≥ 12 weeks;\n9. The function of important organs meets the following requirements (no blood components or cell growth factor drugs are allowed to be used within 14 days before the first medication):\n\n   Absolute neutrophil count ≥ 1.5 × 109\u002FL; Platelets ≥ 100 × 109\u002FL; Hemoglobin ≥ 90 g\u002FL; Serum albumin ≥ 30 g\u002FL; Serum total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN, and if there is liver metastasis, ALT and AST ≤ 5ULN; AKP≤ 2.5×ULN；Serum creatinine ≤ 1.5 × ULN; International normalized ratio (INR) ≤ 1.5 (not receiving anticoagulant therapy);\n10. Non surgical sterilization or female patients of childbearing age are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period and within 3 months after the end of the study treatment period; Female patients of childbearing age who undergo non-surgical sterilization must have a negative serum or urine HCG test within 7 days prior to their first medication; And it must be during non lactation period; For male patients whose partners are women of childbearing age, effective contraception methods should be used during the trial period and within 3 months after the last administration of the trial drug.\n\nExclusion Criteria:\n\n1. Known history or evidence of interstitial lung disease or active non infectious pneumonia;\n2. Known to have central nervous system metastases;\n3. Within the past 5 years or simultaneously with other malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ);\n4. Suffering from hypertension and unable to achieve good control with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); Allow the above parameters to be achieved through the use of antihypertensive therapy; Previously experienced hypertensive crisis or hypertensive encephalopathy;\n5. There are uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA grade 2 or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, (5) QTc\\>450ms (male); QTc\\>470ms (female);\n6. For those undergoing thrombolytic or anticoagulant therapy, prophylactic use of low-dose aspirin and low molecular weight heparin is allowed;\n7. Within the first 3 months of enrollment, there have been significant clinical bleeding symptoms or clear bleeding tendencies; If fecal occult blood is positive during the baseline period, a follow-up examination can be conducted. If the result is still positive after the follow-up examination, gastroscopy examination is required;\n8. Tumor invasion of important blood vessels, or the possibility of tumor invasion of important blood vessels in the future research period determined by imaging, may lead to fatal bleeding;\n9. If the patient has pleural effusion, ascites, or pericardial effusion that requires drainage, and the researcher evaluates the symptoms to be stable after drainage, they can be enrolled;\n10. Occurrence of arterial\u002Fvenous thrombosis events within the first 6 months of enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n11. Known genetic or acquired bleeding and thrombophilia tendencies (such as in hemophilia patients, coagulation dysfunction, etc.);\n12. Within 6 months prior to the start of treatment, there has been an abdominal fistula, gastrointestinal perforation, or abdominal abscess;\n13. Significant vascular disease (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) occurred within 6 months prior to the start of the study treatment;\n14. Severe, unhealed, or cracked wounds, as well as active ulcers or untreated fractures;\n15. Received major surgical treatment (excluding diagnosis) within 4 weeks before the start of the study treatment or expected to undergo major surgical treatment during the study period;\n16. Urine routine shows that urine protein is ≥++and has been confirmed to have a 24-hour urine protein level\\>1.0 g;\n17. Previously received radiotherapy (excluding palliative radiotherapy for bone lesions), chemotherapy, surgery (excluding biopsy), and less than 4 weeks before the first study medication after completion of treatment (last medication); The last dose of antibody administration is less than 4 weeks after the first study medication; Molecular targeted therapy (including other oral targeted drugs used in clinical trials) for patients with less than 5 drug half lives from the first study drug, or adverse reactions caused by previous treatment (excluding hair loss) that have not recovered to ≤ CTCAE grade 1;\n18. Suffering from active infection, having unexplained fever ≥ 38.5 ℃ within 7 days before medication, or baseline white blood cell count\\>15 × 109\u002FL;\n19. Suffering from congenital or acquired immune dysfunction (such as HIV infected individuals); Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 IU\u002Fml, or hepatitis C virus antibody positive;\n20. Previously received anti angiogenic therapy;\n21. According to the researchers' judgment, the patient may have other factors that may affect the research results or cause the study to be terminated midway, such as alcohol abuse, drug abuse, other serious illnesses (including mental illnesses) that require concomitant treatment, serious laboratory test abnormalities, and family or social factors that may affect the patient's safety.",{"count":437,"type":21},65,[439,107],"PHASE1","The efficacy and safety of Pazopanib combined with Palbociclib in the third line and above treatment of refractory solid tumors co amplified in the 11q13 region (FGF3\u002F4\u002F19\u002FCCND1).",[442,443,444],"Solid Tumor, Adult","Next-generation Sequencing","Precision Medicine","2025-03-25",{"date":447,"type":39},"2025-03-26",{"date":449,"type":39},"2024-11-27",{"date":260,"type":21},{"name":45,"class":46},{"id":453,"slug":454,"hasResults":11,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":22,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":470,"locationsCount":47},"100572909","phase-2-precision-medicine-trial-based-on-molecular-matching-therapy-for-patients-with-standard-treatment-exhaustion-100572909","NCT06739395","Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion","A Pan-Cancer Basket, Real World, Open-label, Multicenter Study on Molecular Matching Therapy Guided by Molecular Tumor Boards (MTB) for Pan Solid Tumor Patients With Standard Treatment Exhaustion","Inclusion Criteria:\n\n1. Recurrent or metastatic malignant solid tumors diagnosed by histology or cytology;\n2. ECOG score 0-4 (3-4 points only for patients with tumor burden);\n3. Those who fail or cannot tolerate standard treatment, or those who refuse standard treatment;\n4. At least one measurable lesion that meets the RECIST 1.1 standard;\n5. Expected survival period ≥ 3 months;\n6. Age ≥ 18 years old;\n7. Tumor tissue blocks with sufficient formalin fixed paraffin embedding (FFPE), or chest or ascites with cancer cells detected during treatment (not less than 200ml), or excised metastatic lymph nodes, or peripheral blood (approximately 5m1) can be used for genetic testing;\n8. Understand and voluntarily participate in this study, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients who have actively undergone or are currently participating in clinical trials for treatment;\n2. Serious or uncontrolled medical diseases (i.e. uncontrolled diabetes, chronic kidney disease, chronic lung disease or uncontrolled active infection, mental diseases\u002Fsocial conditions that limit the compliance with the research requirements) that the researchers think will confuse the research treatment response analysis;\n3. Pregnant or lactating patients, or any patients with fertility, have not taken appropriate pregnancy prevention measures.",{"count":226,"type":21},[107],"The main purpose of this study is to explore the feasibility of selecting treatment plans based on genomic variations guided by MTB in patients with advanced refractory solid tumors.",[463,444],"Solid Tumor","2024-12-12",{"date":466,"type":39},"2024-12-18",{"date":468,"type":39},"2024-11-01",{"date":216,"type":21},{"name":45,"class":46},{"id":472,"slug":473,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":11,"sex":298,"minAge":18,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":22,"phases":480,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":491,"locationsCount":47},"100567040","phase-1-rc48-monotherapy-or-combination-with-envafolimab-for-cdk12-alterations-mcrpc-with-standard-treatment-failure-100567040","NCT06663007","RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure","Prospective, Single Arm, Multi Cohort Clinical Study of Disitamab Vedotin(RC48) Monotherapy or Combination With Envafolimab for Second-line Treatment of CDK12 Alterations Metastatic Castration Resistant Prostate Cancer With Standard Treatment Failure","Inclusion Criteria:\n\n1. Participants must be able to understand the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete the trial, and voluntarily sign a written informed consent form;\n2. Patients aged ≥ 18 years old;\n3. Pathological examination confirms non resectable or metastatic HER2 positive castration resistant prostate cancer (mCRPC): HER2 positive is defined as IHC 3+or IHC 2+or FISH+;\n4. Carrying CDK12 mutation combined with ERBB amplification (NGS or FISH) or HER2 IHC (1+, 2+, 3+);\n5. According to the RECIST solid tumor efficacy evaluation criteria, there must be at least one measurable lesion;\n6. ECOG PS: 0-2 points;\n7. Expected survival period is not less than 12 weeks;\n8. Prior exposure to at least one novel endocrine therapy (including abiraterone, enzalutamide, darotamine, apatamide, and rivalutamide) and depletion of PARPi treatment (if AVPC\u002FNEPC, platinum chemotherapy resistance or intolerance is required);\n9. Have not used HER2 targeted drugs (including antibodies, small molecule TKIs, and antibody drug conjugates);\n10. The main organ functions are normal, which meets the following criteria:\n\n1\\) The standard for blood routine examination should meet the requirement of: Hb ≥ 90g\u002FL (no blood transfusion or blood products within 14 days, no correction with G-CSF or other hematopoietic stimulating factors); ANC≥1.5×109\u002FL； PLT≥90×109\u002FL； 2) Biochemical tests must meet the following standards: TBiL≤1×ULN； ALT and AST ≤ 1.5 × ULN; ALP≤2.5×ULN； BUN and Cr ≤ 1.5 × ULN; 3) Cardiac ultrasound: Left ventricular ejection fraction (LVEF) ≥ 50%; 11. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n1. Individuals with a known history of allergies to the components of this medication regimen;\n2. Have other malignant tumors within the past 5 years prior to signing the informed consent form (excluding non melanoma skin cancer or other tumors that have been effectively treated, and malignant tumors that are considered cured);\n3. Existence of brain metastases and\u002For cancerous meningitis;\n4. Previously received allogeneic stem cell or parenchymal organ transplantation;\n5. Past or current congenital or acquired immunodeficiency diseases;\n6. Patients who are known or suspected to have a history of allergies to vediximab or paclitaxel like drugs, or who have a history of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, or who are allergic to excipients of the study drug;\n7. Other significant clinical and laboratory abnormalities, which the researchers believe will affect the safety evaluation, such as uncontrollable diabetes, hypertension, cirrhosis, interstitial pneumonia, obstructive pulmonary disease, chronic kidney disease, peripheral neuropathy of grade II or above (CTCAE V5.0), thyroid dysfunction, heart failure of NYHA grade 3 or above, etc;\n8. Severe infections that are active or poorly controlled clinically; Active infections, including:\n\n   1. AIDS virus (HIV\u002F2 antibody) positive;\n   2. Active hepatitis B (HBsAg positive or HBV DNA\\>2000IU\u002Fml with abnormal liver function);\n   3. Active hepatitis C (HCV antibody positive or HCV RNA ≥ 103 copies\u002Fml with abnormal liver function);\n   4. Active tuberculosis;\n   5. Other uncontrollable active infections (CTCAE V5.0\\>grade 2);\n9. Severe heart disease or discomfort that cannot be treated;\n10. Suffering from mental illness or substance abuse, unable to cooperate;\n11. Simultaneously participating in other clinical trials;\n12. The researchers believe that it is not suitable for the participants to be included.",{"count":479,"type":21},72,[439,107],"The aim of this study is to evaluate the efficacy and safety of vediximab monotherapy or in combination with enrolizumab for second-line treatment of CDK12 alterations mCRPC that has failed standard therapy. The research results are expected to provide new insights and breakthroughs for the treatment of advanced prostate cancer.",[483,484],"Prostate Cancer","CDK12 Gene Mutation","2024-10-26",{"date":487,"type":39},"2024-10-29",{"date":489,"type":39},"2024-09-24",{"date":389,"type":21},{"name":45,"class":46},{"id":493,"slug":494,"hasResults":11,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":11,"sex":298,"minAge":18,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":500,"conditions":501,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":509,"locationsCount":218},"100557331","observation-of-clinical-consistency-of-organoid-chips-drug-sensitivity-in-chemotherapy-for-pca-with-visceral-metastasis-100557331","NCT06536725","Observation of Clinical Consistency of Organoid-chips Drug Sensitivity in Chemotherapy for PCa With Visceral Metastasis","Observation of Clinical Consistency of Organoid-on-chips Drug Sensitivity Detection in Chemotherapy for Prostate Cancer Patients With Visceral Metastasis","Inclusion Criteria:\n\n1. Patients with visceral metastasis of prostate cancer diagnosed clinically or pathologically;\n2. Age ≥ 18 years old;\n3. ECOG score ≤ 2 points or ECOG score 3-4 points due to tumor progression;\n4. Normal liver and kidney function, serum transaminase ALT\\\u003C66 U\u002FL, AST\\\u003C36 U\u002FL, total bilirubin\\\u003C22 umol\u002FL, creatinine\\\u003C106 umol\u002FL, urea nitrogen\\\u003C6.1 mmol\u002FL; Normal bone marrow function: neutrophil count ≥ 1800\u002Fmm3 and platelet count ≥ 100000\u002Fmm3;\n5. Can obtain surgical or biopsy samples;\n6. Patients voluntarily join this study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Patients with severe heart, liver, kidney, and peripheral nervous system diseases, as well as autoimmune diseases such as hyperthyroidism and hypothyroidism; Systemic lupus erythematosus, etc;\n2. Patients who are unable to obtain tissue samples;\n3. Subjects with active pulmonary tuberculosis (TB);\n4. Subjects who are preparing for or have previously undergone tissue\u002Forgan transplantation;\n5. Exclusion criteria are not listed, but the researchers believe that patients who are not suitable to participate in this clinical study.",{"count":274,"type":21},"This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans.",[483,502],"Organoid","2024-08-02",{"date":505,"type":39},"2024-08-05",{"date":507,"type":39},"2024-06-01",{"date":260,"type":21},{"name":45,"class":46},{"id":511,"slug":512,"hasResults":11,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":517,"enrollmentInfo":518,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":519,"conditions":520,"keywords":522,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":47},"100518522","oncolytic-adenovirush101-combined-with-pd-1-inhibitors-in-patients-with-advanced-malignant-pleural-mesothelioma-100518522","NCT06031636","Oncolytic Adenovirus(H101) Combined With PD-1 Inhibitors in Patients With Advanced Malignant Pleural Mesothelioma","Observation of the Efficacy and Safety of Oncolytic Adenovirus Injection Combined With Programmed Death Receptor Inhibitors in Treatment of Advanced Malignant Pleural Mesothelioma : a Single Center, Prospective, Case Registration Study","Inclusion Criteria:\n\n1. Age 18-75 years old (including boundary values), regardless of gender.\n2. Confirmed as late stage MPM patients who have failed immunotherapy.\n3. The patient or their legal representative can understand and sign the informed consent form.\n4. At least one lesion that can safely undergo intratumoral injection or intrapleural injection of oncolytic adenovirus as the target lesion, with a diameter of spiral CT ≥ 1cm or ordinary CT ≥ 2cm, and can be measured through imaging methods.\n5. ECOG score 0-2.\n\nExclusion Criteria:\n\n1. Physicians participating in the study believe that patients may not be able to provide continuous follow-up information.\n2. Any uncontrollable clinical problems (such as severe mental, neurological, cardiovascular, respiratory, and other systemic diseases).\n3. Contraindications to relevant drugs (such as oncolytic adenoviruses, PD-1 inhibitors, etc.)","75 Years",{"count":377,"type":21},"The purpose of this study is to evaluate the efficacy and safety of Oncolytic Adenovirus(H101) combined with PD-1 inhibitor in patients with advanced malignant pleural mesothelioma who have previously been resistant to advanced PD-1 inhibitors.",[521],"Malignant Pleural Mesothelioma, Advanced",[521,523,524],"Oncolytic Adenovirus","Programmed Death Receptor","2023-09-02",{"date":527,"type":39},"2023-09-11",{"date":529,"type":39},"2023-07-20",{"date":531,"type":21},"2026-07-31",{"name":45,"class":46},""]