Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tislelizumab Nab paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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 Nab paclitaxel
Primary outcomes (1)
- 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)
Secondary outcomes (3)
- measure
- Cystectomy-Free Survival (CFS)
- timeFrame
- up to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 diseaseReferences
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