Clinical Trials Logo

Clinical Trial Summary

This is a phase II open label single-arm prospective study aiming to investigate the efficacy of PD-1 inhibitor Tislelizumab combined with conventional gemcitabine and cisplatin as bladder sparing treatment for patients with PD-L1 positive muscle invasive bladder carcinoma (T2-3N0M0).


Clinical Trial Description

The study will enroll 20 patients with adequate organ function and performance status who either wish to attempt bladder preserving therapy or are ineligible for radical cystectomy. The bladder samples must be available and assessed as positive for PD-L1 expression . Patients will receive transurethral resection or partial cystectomy to remove all visible tumors with no residual disease left. After the surgery, patients will receive 8 cycles of tislelizumab combined with 4-6 cycles of gemcitabine and cisplatin. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05401279
Study type Interventional
Source RenJi Hospital
Contact Yunze Xu, PhD
Phone +8618801967501
Email rjxuyunze@163.com
Status Recruiting
Phase Phase 2
Start date June 1, 2022
Completion date May 2025

See also
  Status Clinical Trial Phase
Terminated NCT03606174 - A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma Phase 2
Recruiting NCT05839119 - Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant Phase 1
Completed NCT03558503 - A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer Phase 2
Completed NCT05136898 - Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) Phase 3
Withdrawn NCT06090318 - Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss Phase 1/Phase 2
Recruiting NCT03185468 - Intervention of Bladder Cancer by CAR-T Phase 1/Phase 2
Active, not recruiting NCT05243550 - A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer Phase 3
Recruiting NCT05312671 - Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer Phase 2
Recruiting NCT02951325 - Bladder Cancer Adjuvant Radiotherapy Trial N/A
Recruiting NCT05375903 - A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC) Phase 1
Active, not recruiting NCT04386746 - Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer Phase 2
Recruiting NCT06184516 - Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy Phase 2
Not yet recruiting NCT06331299 - A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer Phase 3
Not yet recruiting NCT05656235 - Renal Retention in High Grade Upper Tract Urothelial Cancer Phase 2
Not yet recruiting NCT05037279 - Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC) Phase 3
Terminated NCT04688931 - A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer Phase 3
Recruiting NCT05241340 - Neoadjuvant Sasanlimab With Radiation as an in Situ Vaccine for Cisplatin-ineligible Muscle Invasive Bladder Cancer Phase 2
Recruiting NCT05077709 - IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC Phase 2
Completed NCT04200963 - A Phase 1a/b Study of IK-175 as a Single Agent and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma Phase 1
Recruiting NCT04770974 - Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic