Status and phase
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About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Histologically confirmed muscle-invasive urothelial cancer of the bladder within 60 days of study enrollment. Variant histology and cis are not allowed. Patients must be willing to provide a TURBT specimen during screening and prior to enrollment if adequate specimen (FFPE tissue block or 20 unstained slides) from initial TURBT documenting muscle-invasive urothelial bladder cancer is not available. The specimen must be assessed as PD-L1 positive by two pathologists using SP263 kit.
Clinical stage T2-T3, N0, M0 urothelial bladder cancer.
Deemed to not be a candidate for radical cystectomy by attending urologic oncologist or refuse radical cystectomy.
Willing to receive maximal transurethral resection or partial cystectomy to remove all bladder tumors
Be willing and able to provide written informed consent/assent for the trial.
Have a performance status of 0 or 2 on the Eastern Cooperative Oncology Group Performance Scale.
Demonstrate adequate organ function as defined below, all screening labs should be performed within 10 days of protocol enrollment.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Central trial contact
Yunze Xu, PhD
Data sourced from clinicaltrials.gov
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