[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509724":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":42,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":11,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Jinling Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RC48-ADC and JS001","EXPERIMENTAL",null,[13],"Drug: RC48-ADC and JS001",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Patients in group will receive 6 x 3 week cycles of RC48-ADC (Disitamab Vedotin) 2mg\u002Fkg in combination with JS001 (Toripalimab) 3mg\u002Fkg intravenously, followed by toripalimab (3 mg\u002Fkg) every 3 weeks for up to 1 year.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Le Qu, M.D.","CONTACT","15720625951","septsoul@hotmail.com",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China","RECRUITING","Nanjing","Jiangsu","210000","China","CN",{"type":35,"coordinates":36},"Point",[37,38],118.77778,32.06167,{"lat":38,"lon":37},[41],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Le Qu","Associate chief urologist","100509724","phase-2-a-study-of-rc48-adc-combined-with-js001-for-postoperative-adjuvant-treatment-of-upper-tract-urothelial-carcinoma-100509724",false,"NCT05917158","A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma","An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of RC48-ADC Combined with JS001 in Postoperative Adjuvant Treatment of HER2-positive Upper Tract Urothelial Carcinoma (UTUC)","1","Inclusion Criteria:\n\n* Written informed consent\n* ≥18 years of age\n* Post radical nephro-ureterectomy for upper tract tumour with predominant TCC component-squamoid differentiation or mixed TCC\u002FSCC is permitted.\n* Histologically confirmed TCC staged pT2-pT4 pN0-2 M0 or pTany N1-2 M0 (providing all grossly abnormal nodes are resected).\n* Pathological tissue immunohistochemistry HER2 2\\~3+\n* Fit and willing to receive adjuvant therapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated\n* ECOG(Eastern Cooperative Oncology Group) performance is 0\\~2.\n* Available for long-term follow-up\n\nExclusion Criteria:\n\n* Evidence of distant metastases\n* Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology\n* Un-resected macroscopic nodal disease\n* Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible)\n* Significant co-morbid conditions that would interfere with administration of protocol treatment\n* Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active);\n* Previous malignancy in the last 5 years except for previous NMIBC, adequately controlled non melanoma skin tumours, CIS of cervix or LCIS of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.","ALL","18 Years",{"count":57,"type":58},30,"ESTIMATED","INTERVENTIONAL",[61],"PHASE2","This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in postoperative adjuvant therapy for HER2-positive upper tract urothelial carcinoma.",[64,65,66],"Carcinoma","Upper Tract Urothelial Carcinoma","UTUC","2025-01-20",{"date":69,"type":70},"2025-01-22","ACTUAL",{"date":72,"type":70},"2022-11-23",{"date":74,"type":58},"2028-12",{"name":5,"class":6},1]