Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Tislelizumab

Cisplatin

Immunomodulating Agents

Antimetabolites

Antineoplastic Agents, Immunological

GC plus Tislelizumab Participants receive GC (Gemcitabine plus cisplatin), in combination with Tislelizumab administered intravenously (IV) every 3 weeks (Q3W) before surgery.Immunotherapy was continued for 6 months after excision of the primary lesion.

Intervention/treatment： Biological: Tislelizumab Tislelizumab IV infusion of 200 mg Q3W

Biological: GC GC (Gemcitabine plus cisplatin): Gemcitabine 1000mg/m2 D1,D8 iv every 3 weeks Cisplatin70mg/m2,D2,3,4 iv every 3 weeks

Tislelizumab Participants receive Tislelizumab administered intravenously (IV) every 3 weeks (Q3W) before surgery.Immunotherapy was continued for 6 months after excision of the primary lesion.

Intervention/treatment： Biological: Tislelizumab Tislelizumab IV infusion of 200 mg Q3W

Primary radical resection plus lymph node dissection was performed in patients with oligometastatic urothelial carcinoma

primary focal resection plus lymph node dissection

GC (Gemcitabine plus cisplatin): Gemcitabine 1000mg/m2 D1,D8 iv every 3 weeks Cisplatin70mg/m2,D2,3,4 iv every 3 weeks

Gemcitabine plus cisplatin

Qikai Wu

Pengchao Li

Qiang Lu, PhD

Pengchao Li, PhD

Qiang Lv

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.

Primary Excision Combined With Preoperative Neoadjuvant and Adjuvant Therapy for Oligometastasis of Urothelial Carcinoma

Trials of Primary Excision Combined With Preoperative Neoadjuvant Therapy and Adjuvant Therapy Was Used as a First-line Comprehensive Therapy for Oligometastasis of Urothelial Carcinoma（UC）.

the percentage of patients who die of any cause within first year of treatment

time between the first objective recording of PD(progressive disease) or death from any cause (whichever occurs first) from random group solstice

Spots Global Cancer Trial Database for primary focal resection plus lymph node dissection