RecruitingPhase 2NCT06091124

Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin in Neuroendocrine Bladder Carcinoma

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


Sponsor

RenJi Hospital

Enrollment

22 participants

Start Date

Nov 16, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of immunotherapy (adebrelimab) plus chemotherapy (etoposide and cisplatin) given before surgery for a rare and aggressive type of bladder cancer called neuroendocrine carcinoma. Researchers want to see if this pre-surgery (neoadjuvant) treatment can shrink the tumor and improve surgical outcomes. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with invasive neuroendocrine carcinoma of the bladder, with neuroendocrine cells making up more than 50% of the tumor - Your cancer is localized (T1–T4a, N0 or limited lymph node involvement, no distant spread) - Your overall health and organ function are adequate (ECOG 0–2) - Your expected survival is longer than 3 months **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have significant heart, liver, or kidney problems - You have active autoimmune disease - You are pregnant or breastfeeding - You have previously received chemotherapy or immunotherapy for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdebrelimab

Adebrelimab 1200 mg IV on Day 1, once every 3 weeks for up to 4 cycles (each cycle = 21 days)

DRUGEtoposide

Etoposide 0.1g IV on Days 1-3, once every 3 weeks for up to 4 cycles (each cycle = 21 days)

DRUGCisplatin

Cisplatin 35mg/m2 IV on Days 1-2, once every 3 weeks for up to 4 cycles (each cycle = 21 days)

PROCEDURERadical Cystectomy

Radical cystectomy should be performed within 4-6 weeks after completion of last dose


Locations(5)

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, China

RenJi Hospital

Shanghai, Shanghai Municipality, China

West China Hospital

Chengdu, Sichuan, China

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06091124


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