Combining Tislelizumab and Nab-Paclitaxel for Bladder Cancer Treatment

A Single-arm, Multicenter, Open Clinical Trial of the Efficacy and Safety of Tislelizumab in Combination With Nab-Paclitaxel for the Perioperative Treatment of Muscle-invasive Bladder Cancer

This study is testing if combining two treatments, tislelizumab and nab-paclitaxel, can help people with muscle-invasive bladder cancer feel better before their surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Second Hospital (Academic / other)
• Drugs / interventions: tislelizumab, immunotherapy
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT05328336 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of tislelizumab combined with nab-paclitaxel as a perioperative treatment for patients with muscle-invasive bladder cancer (MIBC) before undergoing cystectomy or complete transurethral resection of bladder tumor (TURBT). Participants will receive the treatment every three weeks for a total of three cycles over nine weeks, followed by surgical intervention. The study aims to evaluate the effectiveness of this combination therapy in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histopathologically confirmed urothelial carcinoma and suitable for radical cystectomy or complete TURBT.

Not a fit: Patients with non-urothelial carcinoma or those not suitable for the planned surgical interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and outcomes for patients with muscle-invasive bladder cancer.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy and chemotherapy combinations in treating bladder cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Willing and able to provide written informed consent.
2. Ability to comply with the protocol.
3. Age ≥ 18 years.
4. Suitable and planned for complete transurethral resection of bladder tumor or radical cystectomy
5. At least one measurable lesion meeting RECISTv1.1 criteria prior to transurethral bladder tumor electrosurgery (MR/CT long diameter of ≥10 mm or short diameter of ≥15 mm of enlarged lymph node required for this measurable lesion according to RECISTv1.1)
6. Histopathologically confirmed urothelial carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) urothelial cell pattern.
7. Clinical stage T2-T4a NxM0 disease by CT (or MRI).
8. Expected survival time is greater than 12 weeks.
9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 1 or 2.
10. Agree to provide tissue examination specimens (used to detect PD-L1 expression, tumor mutation burden, etc.)
11. The organ function level must meet the following requirements:

    * Hematological indicators: absolute neutrophil count ≥1.5×10\^9/ L, platelet count ≥80×10\^9/L, hemoglobin ≥6.0 g/dL (can be maintained by symptomatic treatment);
    * Liver function: total bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase

      ≤ 2.5 times the upper limit of normal value, if there is intrahepatic transaminase ≤ 5 times the upper limit of normal value;
    * Renal function: creatinine ≤ 2 times the upper limit of normal, and creatinine clearance ≥ 30 ml/min;

Exclusion Criteria:

1. Receive live attenuated vaccines within 4 weeks before treatment or plan to receive live attenuated vaccines during the study period.
2. Active, known or suspected autoimmune diseases.
3. Known history of primary immunodeficiency.
4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
5. Female patients who are pregnant or breastfeeding.
6. Untreated acute or chronic active hepatitis B or C infection. In the case of patients receiving antiviral therapy, the doctor will judge whether they are eligible for enrollment according to the individual conditions of the patient while monitoring the virus copy number.
7. Have used immunosuppressive drugs in the past 4 weeks before starting treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (that is, prednisolone or equivalent physiological doses of no more than 10 mg/day) Other corticosteroids).
8. Those who are known or suspected to be allergic to tislelizumab and nab paclitaxel.
9. Have a clear history of active tuberculosis.
10. Have received PD-1/PD-L1/CTLA-4 antibody or other immunotherapy in the past.
11. Those who are participating in other clinical research.
12. Reproductive men or women who are likely to become pregnant have not taken reliable contraceptive measures.
13. Uncontrolled concurrent diseases include but are not limited to:

    * HIV-infected persons (HIV antibody positive).
    * Serious infections that are active or poorly clinically controlled.
    * There are serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension \[ie refers to After drug treatment, it is still greater than or equal to CTCAE Grade 2 hypertension\]) evidence.
    * Active bleeding or new thrombotic disease.

Where this trial is running

Tianjin, Tianjin

• ianjin Medical University Second Hospital — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Hailong Hu, MD,PhD

Conditions Muscle Invasive Bladder Cancer Urothelial Carcinoma; neoadjuvant treatment