Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:09 AM
Study NCT ID:
NCT07475403
Status:
RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 53}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-Free Survival', 'timeFrame': 'Up to 2 years first administration of systemic immunotherapy', 'description': 'Event-free survival is defined as the time from treatment initiation to the first occurrence of any of the following events: disease recurrence (defined as histologically confirmed urothelial carcinoma detected in the bladder), disease progression to muscle-invasive or metastatic disease, radical cystectomy, or death from any cause. utDNA positivity alone is not considered an event unless accompanied by pathologically confirmed disease recurrence or progression.'}], 'secondaryOutcomes': [{'measure': 'Duration of Complete Response', 'timeFrame': 'Up to 2 years from first documented complete clinical response', 'description': 'Duration of complete response is defined, among participants who achieve complete clinical response (cCR), as the time from the first documentation of cCR to the first occurrence of any of the following events: histologically confirmed intravesical recurrence of urothelial carcinoma, disease progression to muscle-invasive bladder cancer (≥T2 disease), metastasis or death from any cause.'}, {'measure': 'Radical Cystectomy-Free Survival', 'timeFrame': 'Up to 2 years from first administration of systemic immunotherapy', 'description': 'Radical cystectomy-free survival is defined as the time from the first administration of systemic immunotherapy to the first occurrence of either radical cystectomy or death from any cause.'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 2 years from first administration of systemic immunotherapy', 'description': 'Overall survival is defined as the time from the first administration of systemic immunotherapy to death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer', 'Liquid Biopsy', 'Immunotherapy']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate whether urinary tumor DNA (utDNA) can guide treatment duration in patients with unresectable very-high-risk non-muscle-invasive bladder cancer (VHR NMIBC) who achieve complete clinical response after systemic immunotherapy.\n\nParticipants will receive systemic immunotherapy followed by response assessment using pathology, cystoscopy, urine cytology, and utDNA testing. Patients who achieve complete clinical response will receive a short additional course of immunotherapy before stopping treatment according to the study protocol.\n\nThe study hypothesizes that a shortened duration of systemic immunotherapy guided by utDNA monitoring may maintain favorable oncologic outcomes in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/documented residual disease suitable for response assessment by cystoscopy, TURBT/biopsy, 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/L, Platelet count ≥100 × 10⁹/L, Hemoglobin ≥9 g/dL 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/min.\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/TURBT/biopsy, 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."}, 'identificationModule': {'nctId': 'NCT07475403', 'briefTitle': 'Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Second Hospital'}, 'officialTitle': 'A Prospective, Single Center Study of Urinary Tumor DNA-Guided Systemic Immunotherapy in Patients With Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer', 'orgStudyIdInfo': {'id': 'Truce-LB03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'interventionNames': ['Drug: Systemic immunotherapy']}], 'interventions': [{'name': 'Systemic immunotherapy', 'type': 'DRUG', 'description': 'Participants receive systemic immune checkpoint inhibitor therapy administered intravenously every 3 weeks for an initial 3 cycles. Treatment response is then evaluated using transurethral resection of bladder tumor (TURBT) pathology, cystoscopy with biopsy, urinary tumor DNA (utDNA), and urine cytology.\n\nPatients achieving complete clinical response (cCR), defined as negative pathology, negative utDNA, and negative urine cytology, receive an additional 3 cycles of systemic immunotherapy. Treatment is subsequently discontinued if repeat evaluation confirms sustained cCR. Patients who do not meet the cCR criteria continue clinical management and follow-up according to institutional practice.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300000', 'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hailong Hu', 'role': 'CONTACT', 'email': 'xzh200049@163.com', 'phone': '+8615620530409'}], 'facility': 'The Second Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Hailong Hu', 'role': 'CONTACT', 'email': 'huhailong@tmu.edu.cn', 'phone': '+8619801518556'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'At this stage, a decision regarding sharing individual participant data (IPD) has not been finalized. The study involves sensitive clinical and genomic information, including urinary tumor DNA (utDNA) data, and careful consideration is required to ensure protection of participant privacy and compliance with applicable ethical and regulatory requirements. Data sharing policies will be determined after study completion, taking into account institutional policies, participant consent, and data protection regulations. Requests for data may be considered on a case-by-case basis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Second Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}