A Prospective, Single-arm, Exploratory Study on the Efficacy and Safety of Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin in Patients With Neuroendocrine Bladder Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Males or females aged ≥18 years and ≤75 years.

• ECOG performance status of 0 - 2.

• Histologically confirmed invasive neuroendocrine carcinoma with or without urothelial carcinoma, with a neuroendocrine carcinoma component of \>50%; Formalin-fixed paraffin-embedded (FFPE) specimens (preferred) or at least 15 unstained, freshly cut, continuous slides should be submitted with related pathology reports prior to study enrollment. If fewer than 15 slides are available, patients may still be eligible for enrollment after confirmation by the principal investigator. If a tumor tissue section is not available, the tumor tissue must be obtained from the biopsy performed at the time of screening.

• Clinical stage T1-T4a N0 M0 (CT/MRI ± PET/CT) If the clinical stage is T1-4a N1-3 M0, it needs to be judged by the investigator. If cystectomy can still be performed, participants can be included in the study.

• Expected survival longer 3 months.

• Normal function of vital organs (14 days prior to enrollment). Meet the following criteria:

‣ Blood routine examination:

‣ HB≥90 g/L; ANC≥1.5×109 /L; PLT≥100×109 /L.

⁃ No functional organic disease:

∙ T-BIL≤1.5×ULN (upper limit of normal); ALT and AST≤2.5 x ULN; Serum creatinine ≤2×ULN, or endogenous creatinine clearance \> 20 mL /min (Cockcroft-Gault formula); International Standardized ratio (INR), activated partial thromboplastin time (aPTT) : ≤1.5× ULN.

• Fertile males or females must use a highly effective contraceptive approach (such as oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicides) during the trial and continue contraception for 12 months after the end of treatment.

• Participants who voluntarily join the study, sign informed consent, have good compliance, and cooperate with follow-up.

Locations
Other Locations
China
Ren Ji Hospital
RECRUITING
Shanghai
Contact Information
Primary
Haige Chen, M.D.
rjbladder@163.com
86 17702119236
Time Frame
Start Date: 2023-11-16
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 22
Treatments
Experimental: Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin Followed by Radical Cystectomy
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.
Sponsors
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov

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