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

  • STATUS
    Recruiting
  • End date
    Jul 6, 2024
  • participants needed
    63
  • sponsor
    Tianjin Medical University Second Hospital
Updated on 6 November 2021

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.

Details
Condition High Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma
Treatment Nab-paclitaxel, tislelizumab
Clinical Study IdentifierNCT04730232
SponsorTianjin Medical University Second Hospital
Last Modified on6 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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 Criteria

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
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