Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-01 @ 12:21 AM
Study NCT ID:
NCT04730232
Status:
UNKNOWN
Last Update Posted:
2021-10-29
First Post:
2021-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tilelizumab Combined With Nab-Paclitaxel for High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707970', 'term': 'tislelizumab'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-22', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Response (CR) Rate for tilelizumab combined with nab-paclitaxel', 'timeFrame': 'At the time of transurethral resection biopsy (within 9 or 12 weeks of the first dose of tislelizumab)'}], 'secondaryOutcomes': [{'measure': 'Cystectomy-Free Survival (CFS)', 'timeFrame': 'up to 3 years', 'description': 'defined from D1 of treatment until cystectomy.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'up to 3 years'}, {'measure': 'Number of adverse events and severity by grade (CTCAE)', 'timeFrame': '12 weeks of treatment plus 30 days for toxicity followup', 'description': 'Safety and toxicity will be characterized according to the reported adverse event (AE) profile using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0, as well as a patient questionnaire derived from the Patient Reported Outcomes (PRO)-CTCAE and Patient Reported Outcomes Measurement Information System (PROMIS).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tislelizumab', 'Nab-Paclitaxel'], 'conditions': ['High-Risk', 'Non-Muscle Invasive Bladder Urothelial Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a phase II study to determine the safety and efficacy of tislelizumab when given in combination with nab-paclitaxel as treatment for patients with high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not completely resectable. Patients will receive treatment with tislelizumab in combination with nab-paclitaxel every 3 weeks for 4 treatment cycles over 12 weeks followed by transurethral resection biopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Willing and able to provide written informed consent;\n2. Ability to comply with the protocol;\n3. Age ≥ 18 years;\n4. High-risk non-muscle-invasive urothelial carcinoma or high-risk non-muscle-invasive urothelial carcinoma as the main pathological component \\> 50%, difined as following:\n\n a. T1 b. High-grade Ta c.Carcinoma in situ(CIS);\n5. Multi-point biopsy of bladder shows there are more than 2 section and over 3 points of pathological specimens are diagnosed as above, meanwhile, the tumor has to be diagnosed as not completely resectable by at least 2 senior urologist;\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;\n7. Agreed to provide tissue examination samples (for detection of PD-L1 expression, tumor mutation load, IHC, detection of DNA and RNA, etc;)\n8. Organ function level must meet the following requirements:\n\n * Hematological indexes: neutrophil count \\>= 1.5x10\\^9/L, platelet count \\>= 80x10\\^9/L, hemoglobin \\>= 6.0 g/dl (can be maintained by blood transfusion);\n * Liver function: total bilirubin \\<=1.5 ULN, alanine aminotransferase and aspartate aminotransferase \\<=2.5 ULN;\n9. The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up;\n\nExclusion Criteria:\n\n1. Receive live attenuated vaccine within 4 weeks before treatment or during the study period;\n2. Active, known or suspected autoimmune diseases;\n3. History of primary immunodeficiency;\n4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n5. Pregnant or lactating female patients;\n6. Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;\n7. Prior use of immunosuppressive drugs within 4 weeks prior to the start of treatment, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e. not more than 10 mg / day prednisolone or other corticosteroids with the same physiological dose);\n8. Known or suspected allergy to tislelizumab and albumin paclitaxel;\n9. Have a clear history of active tuberculosis;\n10. Received PD-1 / PD-L1 / CTLA-4 antibody or other immunotherapy in the past;\n11. Participating in other clinical researchers;\n12. Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;\n13. Uncontrolled concurrent diseases, including but not limited to:\n\n * HIV infected (HIV antibody positive);\n * Severe infection in active stage or poorly controlled;\n * Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension \\[i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment\\]);\n * Patients with active bleeding or new thrombotic disease."}, 'identificationModule': {'nctId': 'NCT04730232', 'briefTitle': 'Tilelizumab Combined With Nab-Paclitaxel for High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Second Hospital'}, 'officialTitle': 'An Open Label, Single-arm, Phase 2 Study of Tislelizumab Combined With Nab-Paclitaxel for Patients With High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable', 'orgStudyIdInfo': {'id': 'Truce-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tislelizumab and Nab-Paclitaxel', 'description': 'Tislelizumab 200mg IV on day 1 in combination with nab-paclitaxel 200mg IV on day 2 every 3 weeks for 3 or 4 cycles followed by transurethral resection biopsy.', 'interventionNames': ['Drug: Tislelizumab', 'Drug: Nab-paclitaxel']}], 'interventions': [{'name': 'Tislelizumab', 'type': 'DRUG', 'otherNames': ['BGB-A317'], 'description': 'Tislelizumab 200mg will be administered on Day 1 of each cycle for 4 treatment cycles.', 'armGroupLabels': ['Tislelizumab and Nab-Paclitaxel']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'description': 'Nab-paclitaxel 200mg will be administered on Day 2 of each cycle for 4 treatment cycles.', 'armGroupLabels': ['Tislelizumab and Nab-Paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300211', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hailong Hu', 'role': 'CONTACT', 'email': 'hhllove2004@163.com', 'phone': '+86-13662096232'}], 'facility': 'Tianjin Medical University Second Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Hailong Hu, MD,PhD', 'role': 'CONTACT', 'email': 'hhllove2004@163.com', 'phone': '+86-13662096232'}], 'overallOfficials': [{'name': 'Hailong Hu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University Second Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Second Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}