Overview

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

Status:
Recruiting
Trial end date:
2024-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tianjin Medical University Second Hospital
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
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);

- Liver function: total bilirubin <=1.5 ULN, alanine aminotransferase and aspartate
aminotransferase <=2.5 ULN;

9. The subjects volunteered to join the study, signed informed consent, and had good
compliance with follow-up;

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;

11. Participating in other clinical researchers;

12. Men with reproductive capacity or women who are likely to become pregnant do not take
reliable contraceptive measures;

13. 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.