The goal of this clinical trial is to learn about the efficacy and safety of neoadjuvant adebrelimab plus etoposide and cisplatin in patients with neuroendocrine bladder carcinoma. The main questions it aims to answer are: * The pathologic complete response rate at radical cystectomy * Safety and tolerability of combination therapy Participants will be treated with a combination therapy of adebrelimab, etoposide, and cisplatin before radical cystectomy, with a maximum of 4 cycles.
This is an prospective, single-arm, open-label clinical study of neoadjuvant adebrelimab in combination with etoposide and cisplatin in patients with neuroendocrine bladder carcinoma. Approximately 22 participants will be enrolled in this study to evaluate the efficacy and safety of neoadjuvant adebrelimab, cisplatin and etoposide. The study population will include male and female patients over the age of 18 with invasive (cT1-cT4) neuroendocrine carcinoma of the bladder, with or without urothelial component (neuroendocrine component should be \>50%). Patients with resectable N1-3 disease (judged by investigators) are eligible. Patients should be fit to undergo cystectomy with normal function of vital organs. Participants will be intravenously treated with adebrelimab (1200mg, day 1) in combination with etoposide (0.1g, day 1-3) and cisplatin (35mg/m2, day 1-2) every 21 days for a maximum of 4 cycles. Radical cystectomy, lymph node dissection and urine diversion will be performed after the completion of therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Adebrelimab 1200 mg IV on Day 1, once every 3 weeks for up to 4 cycles (each cycle = 21 days)
Etoposide 0.1g IV on Days 1-3, once every 3 weeks for up to 4 cycles (each cycle = 21 days)
Cisplatin 35mg/m2 IV on Days 1-2, once every 3 weeks for up to 4 cycles (each cycle = 21 days)
Radical cystectomy should be performed within 4-6 weeks after completion of last dose
Jiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGThe First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China
RECRUITINGRenJi Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGWest China Hospital
Chengdu, Sichuan, China
RECRUITINGThe Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
RECRUITINGPathologic complete response (ypCR) at cystectomy
The number of participants with pathologic complete responses (ypCR) at cystectomy. Pathologic complete response is defined as post-treatment stages of T0N0M0 .
Time frame: At the time of radical cystectomy (within 18 weeks of the first dose)
Safety and tolerability of combination therapy and radical cystectomy
The number of participants experiencing treatment-related adverse events, defined by NCI CTCAE 5.0
Time frame: Up to 2 years
Pathologic downstage at cystectomy
The number of participants with pathological downstage at cystectomy. Pathologic downstage response is defined as downstaged T stage or N stage at cystectomy .
Time frame: At the time of radical cystectomy (within 18 weeks of the first dose)
Progression Free Survival
Defined by time from day of first treatment to disease progression
Time frame: Up to 2 years
Cancer Specific Survival
Defined by time from day of first treatment to death of the disease
Time frame: Up to 2 years
Overall Survival
Defined by time from day of first treatment to death
Time frame: Up to 2 years
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