Neoadjuvant therapy of cisplatin-based chemotherapy has been proved to improve prognosis of muscle invasive UTUC patients in several studies. This study is designed to investigate the safety and efficacy of neoadjuvant PD-1 monoclonal antibody in patients with locally advanced upper urinary tract urothelial carcinoma (UTUC) which are ineligible for cisplatin. Tislelizumab, an anti-programmed death protein-1 (PD-1) monoclonal antibody, was engineered to minimize binding to FcγR on macrophages to abrogate antibody-dependent phagocytosis, a mechanism of T-cell clearance and potential resistance to anti-PD-1 therapy. The safety, tolerability, and efficacy of tislelizumab in patients with PD-L1 positive urothelial carcinoma who progressed during/following platinum-containing therapy was proved in a phase 2 trial (CTR20170071). This trial focuses on the efficacy of Tislelizumab to induce pathological down-staging of locally advanced UTUC in neoadjuvant setting.
Neoadjuvant therapy of cisplatin-based chemotherapy has been proved to improve prognosis of muscle invasive UTUC patients in several studies. This study is designed to investigate the safety and efficacy of neoadjuvant PD-1 monoclonal antibody in patients with locally advanced upper urinary tract urothelial carcinoma (UTUC) which are ineligible for cisplatin. Tislelizumab, an anti-programmed death protein-1 (PD-1) monoclonal antibody, was engineered to minimize binding to FcγR on macrophages to abrogate antibody-dependent phagocytosis, a mechanism of T-cell clearance and potential resistance to anti-PD-1 therapy. The safety, tolerability, and efficacy of tislelizumab in patients with PD-L1 positive urothelial carcinoma who progressed during/following platinum-containing therapy was proved in a phase 2 trial (CTR20170071). This trial focuses on the efficacy of Tislelizumab to induce pathological down-staging of locally advanced UTUC in neoadjuvant setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Patients will receive 2-4 cycles of Tislelizumab (200mg per cycle) before surgery(radical nephroureterectomy, segmental ureteral resection, endoscopic ablation)
Shanghai Renji Hospital
Shanghai, Shanghai Municipality, China
pathological reponse rate
ypT0N0 at surgical specimen,in the intention-to-treat population
Time frame: 30 days after surgery
pathological response rate
ypT0 and ypT1 at surgical specimen,in the intention-to-treat population
Time frame: 30 days after surgery
perioperative complication rate
the rate of perioperative complications are determined according to Clavien classification
Time frame: 30 days after surgery
objective response rate
the proportion of patients with a confirmed complete response or partial response based on radiological examination before surgery per RECIST version 1.1
Time frame: 12 months after drug treatment
disease free survival
from surgery to any kind of recurrence including tumour bed, first metastasis, or death from any cause
Time frame: 5 years after surgery or treatment
overall survival
time from enrollment to death for any cause
Time frame: 5 years after enrollment
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