Neoplasms

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Urologic Neoplasms

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Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

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Transitional Cell Carcinoma

Antineoplastic Agents

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Paclitaxel

Tislelizumab

Albumin-Bound Paclitaxel

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Antineoplastic Agents, Immunological

Experimental: Tislelizumab and Nab Paclitaxel Tislelizumab 200mg IV on day 1 in combination with nab paclitaxel 200mg IV on day 2 every 3 weeks for 3 cycles followed by surgery.

Drug: Tislelizumab Tislelizumab 200mg will be administered on Day 1 every 3 weeks for 3 cycles

Other Names:

• BGB-A317 Drug: Nab paclitaxel Nab paclitaxel 200mg will

Tislelizumab Nab paclitaxel

Hailong Hu, MD,PhD

This is a single-arm, open-label, multicenter clinical trial to investigate the safety and efficacy of tislelizumab when given in combination with nab-paclitaxel as perioperative treatment in patients with muscle-invasive bladder cancer (MIBC) prior to cystectomy or complete TURBT. Patients will receive perioperative treatment with tislelizumab in combination with nab-paclitaxel every 3 weeks for 3 treatment cycles over 9 weeks followed by radical cystectomy or complete TURBT.

Perioperative Tislelizumab Combined With Nab-Paclitaxel for Muscle-invasive Urothelial Bladder Cancer: A Multicenter Study

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

defined as the percentage of participants having CR. CR is defined as absence of viable tumor in examined tissue

defined as pT0-T1N0M0 at the time of cystectomy or cTURBT

defined as the proportion of patients who have a partial or complete response to therapy

defined from D1 of neoadjuvant treatment until progression (in those who progress prior to surgery) or until recurrence (post-surgery) or until death as a result of any cause.

defined as the number of days from study entry to death. Individuals who are alive at last contact will be censored on the date of last contact.

Safety and toxicity will be characterized according to the reported adverse event (AE) profile using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0, as well as a patient questionnaire derived from the Patient Reported Outcomes (PRO)-CTCAE and Patient Reported Outcomes Measurement Information System (PROMIS).

Tianjin Medical University Second Hospital

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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.

Tislelizumab 200mg will be administered on Day 1 of each cycle for 4 treatment cycles;Nab-paclitaxel 200mg will be administered on Day 2 of each cycle for 4 treatment cycles.

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.

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

defined from D1 of treatment until cystectomy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Perioperative Tislelizumab Combined With Nab-Paclitaxel for Muscle-invasive Urothelial Bladder Cancer: A Multicenter Study	NCT05328336	Muscle Invasive...	Tislelizumab Na...	18 Years -	Tianjin Medical University Second Hospital
Tilelizumab Combined With Nab-Paclitaxel for High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable: a Multi-center Study	NCT05418309	High-Risk Non-M...	Tislelizumab Na...	18 Years -	Tianjin Medical University Second Hospital
Perioperative Tislelizumab Combined With Nab-Paclitaxel for Muscle-invasive Urothelial Bladder Cancer: A Multicenter Study	NCT05328336	Muscle Invasive...	Tislelizumab Na...	18 Years -	Tianjin Medical University Second Hospital

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