treatment of primary focal resection plus lymph node dissection combined with chemotherapy and anti-programmed cell death 1(PD-1) for Oligometastasis of urothelial carcinoma.
The study is designed to demonstrate that Whether the perioperative comprehensive treatment of primary focal resection plus lymph node dissection combined with chemotherapy and anti-PD-1 can prolong the overall survival of patients, narrow the range of metastatic lesions and improve the quality of life of patients. Compared with patients with extensive metastasis, 2-year tumor-specific survival and overall survival of patients with oligometastatic bladder cancer were significantly increased (53.3% vs 16.1%);(51.9% vs. 15.4%).Gemcitabine plus cisplatin (GC) regimen has been shown to bring clinical benefits in neoadjuvant therapy of metastatic UC(urothelial carcinoma). PD-1 inhibitors have been widely used in urothelial carcinoma in recent years, and positive data have been obtained in both advanced patients and neoadjuvant patients. If successful in this trial, it will serve to provide a therapeutic alternative for this patient who have oligometastasis of urothelial carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Primary radical resection plus lymph node dissection was performed in patients with oligometastatic urothelial carcinoma
Tislelizumab IV infusion of 200 mg Q3W
GC (Gemcitabine plus cisplatin): Gemcitabine 1000mg/m2 D1,D8 iv every 3 weeks Cisplatin70mg/m2,D2,3,4 iv every 3 weeks
The first affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Pathological complete response (ypT0N0)
Pathological confirmation is ypT0N0
Time frame: From treatment to surgery
Pathological downstaging
Pathological confirmation is \<ypT2N0
Time frame: From treatment to surgery
progression-free survival(PFS)
time between the first objective recording of PD(progressive disease) or death from any cause (whichever occurs first) from first treatment.
Time frame: through study completion, an average of 1 year
Overall survival (OS)
time between death (any causes) from first treatment.
Time frame: through study completion, an average of 1 year
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