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Tilelizumab Combined With Nab-Paclitaxel for High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable: a Multi-center Study | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Tilelizumab Combined With Nab-Paclitaxel for High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable: a Multi-center Study

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: a Multi-center Study

NCT05418309•Tianjin Medical University Second Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Willing and able to provide written informed consent;
•2. Ability to comply with the protocol;
•3. Age ≥ 18 years;
•4. High-risk non-muscle-invasive urothelial carcinoma or high-risk non-muscle-invasive urothelial carcinoma as the main pathological component \> 50%, difined as following:
•a. T1 b. High-grade Ta c.Carcinoma in situ(CIS);
•5. 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;
•6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
•7. Agreed to provide tissue examination samples (for detection of PD-L1 expression, tumor mutation load, IHC, detection of DNA and RNA, etc;)
•8. Organ function level must meet the following requirements:
•* Hematological indexes: neutrophil count \>= 1.5x10\^9/L, platelet count \>= 80x10\^9/L, hemoglobin \>= 6.0 g/dl (can be maintained by blood transfusion);
+2 more criteria

Exclusion Criteria

•1. Receive live attenuated vaccine within 4 weeks before treatment or during the study period;
•2. Active, known or suspected autoimmune diseases;
•3. History of primary immunodeficiency;
•4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
•5. Pregnant or lactating female patients;
•6. 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;
•7. 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);
•8. Known or suspected allergy to tislelizumab and albumin paclitaxel;
•9. Have a clear history of active tuberculosis;
•10. Received PD-1 / PD-L1 / CTLA-4 antibody or other immunotherapy in the past;
+7 more criteria

Locations (1)

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

December 27, 2021

Primary Completion Date

February 1, 2024

Completion Date

July 1, 2024

Last Updated

June 14, 2022

Enrollment

ESTIMATED participants

Conditions

High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma

Interventions

Tislelizumab Nab paclitaxel

DRUG

Contacts

Hailong Hu, MD,PhD

CONTACT

+86-13662096232 hhllove2004@163.com