Status:
UNKNOWN
Tilelizumab Combined With Nab-Paclitaxel for High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable
Lead Sponsor:
Tianjin Medical University Second Hospital
Conditions:
High-Risk
Non-Muscle Invasive Bladder Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent;
- Ability to comply with the protocol;
- Age ≥ 18 years;
- 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);
- 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;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
- Agreed to provide tissue examination samples (for detection of PD-L1 expression, tumor mutation load, IHC, detection of DNA and RNA, etc;)
- 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);
- Liver function: total bilirubin \<=1.5 ULN, alanine aminotransferase and aspartate aminotransferase \<=2.5 ULN;
- The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up;
Exclusion
- Receive live attenuated vaccine within 4 weeks before treatment or during the study period;
- Active, known or suspected autoimmune diseases;
- History of primary immunodeficiency;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Pregnant or lactating female patients;
- 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;
- 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);
- Known or suspected allergy to tislelizumab and albumin paclitaxel;
- Have a clear history of active tuberculosis;
- Received PD-1 / PD-L1 / CTLA-4 antibody or other immunotherapy in the past;
- Participating in other clinical researchers;
- Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;
- Uncontrolled concurrent diseases, including but not limited to:
- HIV infected (HIV antibody positive);
- Severe infection in active stage or poorly controlled;
- 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 \[i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment\]);
- Patients with active bleeding or new thrombotic disease.
Key Trial Info
Start Date :
December 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04730232
Start Date
December 27 2020
End Date
July 1 2024
Last Update
October 29 2021
Active Locations (1)
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1
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China, 300211