Who is sponsoring NCT05418309?

NCT05418309 is sponsored by Tianjin Medical University Second Hospital.

What drugs are being tested in NCT05418309?

Interventions in NCT05418309: Tislelizumab Nab paclitaxel.

What condition does NCT05418309 study?

NCT05418309 studies High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma.

Is NCT05418309 still recruiting?

NCT05418309 is currently status unknown. Last updated 9 June 2022.

Last reviewed 2022-06-09 · How we verify

NCT05418309

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 2 Last updated 9 June 2022

What this trial tests

Phase 2 trial testing Tislelizumab Nab paclitaxel in High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma in 63 participants. Status unknown.

Timeline

27 December 2021

Primary endpoint
1 February 2024

1 July 2024

Quick facts

Lead sponsor	Tianjin Medical University Second Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	63
Start date	27 December 2021
Primary completion	1 February 2024
Estimated completion	1 July 2024
Sites	1 location across China

Drugs / interventions tested

Tislelizumab Nab paclitaxel

Conditions studied

High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma — all drugs for High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma →

Sponsor

Tianjin Medical University Second Hospital

Who can join

18 and older, any sex, with High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Complete Response (CR) Rate for tilelizumab combined with nab-paclitaxel
Time frame: At the time of transurethral resection biopsy (within 9 or 12 weeks of the first dose of tislelizumab)

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Novel immunotherapeutic options for BCG-unresponsive high-risk non-muscle-invasive bladder cancer.
Hannouneh ZA, Hijazi A, Alsaleem AA, Hami S, et al · · 2023 · cited 26× · PMID 38037752 · DOI 10.1002/cam4.6768
Emerging bladder-sparing treatments for high risk non-muscle invasive bladder cancer.
Gurbani CM, Chong YL, Choo ZW, Chia D, et al · · 2025 · cited 1× · PMID 40584211 · DOI 10.1177/23523735251348842
Immune checkpoint inhibitors in BCG-unresponsive non-muscle-invasive bladder cancer: a narrative review of evidence and future directions.
Zhao L, Yang JW, Chen SY, Wang L, et al · · 2026 · PMID 41658461 · DOI 10.21037/tau-2025-717

Verify or expand the search:

Other trials of Tislelizumab Nab paclitaxel

Trials testing the same drug.

NCT07145931 — Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Immunotherapy for Head and Neck Squamous Cell Carcinoma Invadi · Phase 2 · not yet recruiting

Other Tianjin Medical University Second Hospital trials

Trials by the same sponsor.

NCT07170293 — Phase II Trial of Tunlametinib in Patients With NRAS Mutant Non-melanoma Refractory Solid Tumors · Phase 2 · recruiting
NCT07475403 — Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
NCT07321197 — Radical Nephrectomy With vs Without Template Lymph Node Dissection in High-Risk Renal Cell Carcinoma (T-LND RCC): A Rand · NA · not yet recruiting
NCT07321210 — Radical Nephroureterectomy With vs Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma · NA · recruiting
NCT07233252 — Nephron-sparing Treatment of Tislelizumab + Nab-Paclitaxel for Renal Pelvic Cancer · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05418309 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tianjin Medical University Second Hospital
Last refreshed: 9 June 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05418309.

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