Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-01-05 @ 1:20 PM
Study NCT ID:
NCT05917158
Status:
RECRUITING
Last Update Posted:
2025-01-22
First Post:
2023-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2023-06-15', 'studyFirstSubmitQcDate': '2023-06-15', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival (DFS)', 'timeFrame': '5 years', 'description': '5-year Disease-free survival'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Patients followed-up for 5 years', 'description': '5-year Overall Survival'}, {'measure': 'Metastasis free survival (MFS)', 'timeFrame': 'Patients are followed up for 5 years', 'description': '5-year Metastasis free survival'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carcinoma', 'Upper Tract Urothelial Carcinoma', 'UTUC']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This is an open-label, single-arm clinical trial to evaluate the efficacy and safety of RC48-ADC, a recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate, in combination with JS001, a PD-1 monoclonal antibody, for the postoperative adjuvant treatment of HER2-positive upper tract urothelial carcinoma after radical nephroureterectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/SCC 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.'}, 'identificationModule': {'nctId': 'NCT05917158', 'acronym': '1', 'briefTitle': 'A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '2022DZKY-106-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RC48-ADC and JS001', 'interventionNames': ['Drug: RC48-ADC and JS001']}], 'interventions': [{'name': 'RC48-ADC and JS001', 'type': 'DRUG', 'description': 'Patients in group will receive 6 x 3 week cycles of RC48-ADC (Disitamab Vedotin) 2mg/kg in combination with JS001 (Toripalimab) 3mg/kg intravenously, followed by toripalimab (3 mg/kg) every 3 weeks for up to 1 year.', 'armGroupLabels': ['RC48-ADC and JS001']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Le Qu, M.D.', 'role': 'CONTACT', 'email': 'septsoul@hotmail.com', 'phone': '15720625951'}], 'facility': 'Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Le Qu, M.D.', 'role': 'CONTACT', 'email': 'septsoul@hotmail.com', 'phone': '15720625951'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinling Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate chief urologist', 'investigatorFullName': 'Le Qu', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}