MedTrace Logo

Bladder Sparing Treatment of Tislelizumab, Gemcitabine and Cisplatin for Patients With PD-L1 Positive Muscle Invasive Bladder Cancer

NCT05401279 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-08-18

No results posted yet for this study

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).

Conditions

  • Urothelial Carcinoma Bladder
  • PD-1 Inhibitor

Interventions

DRUG

Tislelizumab

Tislelizumab 200mg will be administered on Day 1 of each 21 day cycle for 8 21-day cycles.

DRUG

Gemcitabine

Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four to six 21-day cycles.

DRUG

Cisplatin

Cisplatin 70mg\^m2 will be administered on Day 1 for four to six 21-day cycles.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Wei Xue, PhD · Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-04-30
Completion
2025-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05401279 on ClinicalTrials.gov