NCT04730232 is a Phase 2 clinical trial of Tislelizumab in High-Risk, sponsored by Tianjin Medical University Second Hospital.

Who is sponsoring NCT04730232?

NCT04730232 is sponsored by Tianjin Medical University Second Hospital.

What drugs are being tested in NCT04730232?

Interventions in NCT04730232: Tislelizumab, Nab-paclitaxel.

What condition does NCT04730232 study?

NCT04730232 studies High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma.

Is NCT04730232 still recruiting?

NCT04730232 is currently status unknown. Last updated 22 October 2021.

Last reviewed 2021-10-22 · How we verify

NCT04730232

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

Status unknown Phase 2 Last updated 22 October 2021

What this trial tests

Phase 2 trial testing Tislelizumab in High-Risk in 63 participants. Status unknown.

Timeline

27 December 2020

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 2020
Primary completion	1 February 2024
Estimated completion	1 July 2024
Sites	1 location across China

Drugs / interventions tested

Tislelizumab (TISLELIZUMAB) — full drug profile →
Nab-paclitaxel (nab-paclitaxel) — full drug profile →

Conditions studied

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

Sponsor

Tianjin Medical University Second Hospital

Who can join

18 and older, any sex, with High-Risk or 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

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

New Perspectives in the Medical Treatment of Non-Muscle-Invasive Bladder Cancer: Immune Checkpoint Inhibitors and Beyond.
Audisio A, Buttigliero C, Delcuratolo MD, Parlagreco E, et al · · 2022 · cited 28× · PMID 35159167 · DOI 10.3390/cells11030357
Research Advances in Clinical Applications, Anticancer Mechanism, Total Chemical Synthesis, Semi-Synthesis and Biosynthesis of Paclitaxel.
Zhang S, Ye T, Liu Y, Hou G, et al · · 2023 · cited 26× · PMID 38005238 · DOI 10.3390/molecules28227517
Recent Advances in Drug Delivery Strategies for High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: A Brief Review from 2018 to 2024.
Qu F, Darji S, Thompson DH. · · 2024 · cited 11× · PMID 39339191 · DOI 10.3390/pharmaceutics16091154
Phase II Pilot Trial of Tislelizumab plus Low-Dose Nab-Paclitaxel for Extensive Very High-Risk Non-Muscle-Invasive Bladder Cancer.
Qie Y, Huang S, Shen C, Wu Z, et al · · 2025 · cited 6× · PMID 39777450 · DOI 10.1158/1078-0432.ccr-24-3321
Nanotherapeutics Plus Immunotherapy in Oncology: Who Brings What to the Table?
Timon-David E, Perez C, Rodallec A. · · 2022 · cited 2× · PMID 36365144 · DOI 10.3390/pharmaceutics14112326
Electrocardiographic characteristics of bladder cancer patients receiving preoperative chemotherapy combined with immunotherapy.
Chen ZL, Jia KP, Zheng Y, Zhang N, et al · · 2024 · cited 1× · PMID 38288514 · DOI 10.1111/anec.13107

Verify or expand the search:

Other trials of Tislelizumab

Trials testing the same drug.

NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer · Phase 2 · not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · recruiting
NCT07290985 — AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas · Phase 2 · not yet recruiting
NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin · Phase 2 · not yet recruiting

Other recruiting trials for High-Risk

Currently open trials in the same condition.

NCT05877573 — Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Recta · NA · 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 NCT04730232 (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: 22 October 2021

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/NCT04730232.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing