Actively Recruiting
Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin in Neuroendocrine Bladder Carcinoma
Led by RenJi Hospital · Updated on 2025-12-08
22
Participants Needed
5
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin in Neuroendocrine Bladder Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years to 75 years
- ECOG performance status of 0 to 2
- Histologically confirmed invasive neuroendocrine carcinoma of the bladder with a neuroendocrine component greater than 50%
- Clinical stage T1 to T4a N0 M0 or resectable N1 to N3 M0 disease
- Expected survival longer than 3 months
- Normal function of vital organs within 14 days prior to enrollment, including blood counts and liver and kidney function
- Fertile participants must use highly effective contraception during the trial and for 12 months after treatment
- Voluntary informed consent, good compliance, and cooperation with follow-up
You will not qualify if you...
- Prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy
- Prior drug therapy for cancer except intravesical chemotherapy or immunotherapy ended at least 1 week before study start
- Prior radiotherapy for bladder cancer
- Allergy to adebrelimab or its components
- Recent antitumor or immunomodulatory therapy or participation in other clinical trials within 4 weeks before study
- Pregnant or lactating females
- HIV positive status
- Active hepatitis B or C infection
- Active tuberculosis
- Active autoimmune disease requiring systemic treatment within past 2 years
- Serious uncontrolled medical conditions including severe infections, uncontrolled diabetes, significant heart or lung disease
- Receipt of live vaccine within 4 weeks before treatment
- Prior allogeneic stem cell or solid organ transplantation
- History of psychotropic substance abuse or mental disorders
- Pleural fluid or ascites requiring management
- Other malignancies not healed in past 5 years except certain cured or localized cancers
- Upper tract urothelial carcinoma
- Other severe medical or psychiatric disorders or lab abnormalities that may affect participation or result interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Actively Recruiting
2
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China
Actively Recruiting
3
RenJi Hospital
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
4
West China Hospital
Chengdu, Sichuan, China
Actively Recruiting
5
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
H
Haige Chen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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