Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Recruiting Phase 2

Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin in Neuroendocrine Bladder Carcinoma

NCT06091124 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2023-11-16
Last updated
2025-12-08

Condition(s) studied

Neuroendocrine Carcinoma of the BladderBladder Cancer

Investigational drug(s) / intervention(s)

Adebrelimab →Etoposide →Cisplatin →Radical Cystectomy

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

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

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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: 1. Blood routine examination: HB≥90 g/L; ANC≥1.5×109 /L; PLT≥100×109 /L. 2. 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. Exclusion Criteria: * 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 the start of study. * Prior radiotherapy for bladder cancer. * Participants allergic to adebrelimab and its components. * Participants who have received other antitumor therapy or immunomodulatory therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks before the start of study treatment, or have not recovered from previous toxicity (except for 2 degree alopecia and 1 degree neurotoxicity). * Pregnant or lactating females. * HIV Positive. * Participants with active hepatitis B or C: For participants with HBsAg or HBcAb positive and detected HBV DNA copy number (quantitative detection limit is 500IU/ml, or reach the positive value of copy number detected by the research center), HBV DNA must be tested for screening in such patients. Participants positive for HCV antibodies were enrolled in this study only if the PCR test for HCV RNA was negative. * Active tuberculosis. * Active autoimmune disease that requires systemic treatment within the past 2 years (such as disease-modulating drugs, corticosteroids, or immunosuppressive drugs). Replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for renal or pituitary insufficiency) are accepted. * Other serious, uncontrolled medical conditions that may affect protocol adherence or interfere with interpretation of results. These include active opportunistic or progressive (severe) infections, uncontrolled diabetes, cardiovascular disease (heart failure as defined by the New York Heart Association scale as grade III or IV, cardiac conduction block above grade II, myocardial infarction within the last 6 months, unstable arrhythmia or unstable angina, cerebral infarction within the last 3 months, etc.), or pulmonary disease (interstitial pneumonia, Obstructive pulmonary disease and a history of symptomatic bronchospasm). * Those who received live vaccine within 4 weeks prior to the start of treatment (seasonal influenza vaccines are usually inactivated and therefore permitted for use). Intranasal vaccines are live vaccines, so they are not allowed to be used). * Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation. * History of psychotropic substance abuse and cannot abstain or have a history of mental disorders. * Pleural fluid or ascites associated with clinical symptoms or requiring symptomatic management. * Participants with other malignancies that have not healed in the past 5 years, excluding apparently cured malignancies, or curable cancers such as basal or squamous cell skin cancer, localized low-risk prostate cancer, cervical carcinoma in situ, or breast carcinoma in situ. * Concomitant upper tract urothelial carcinoma (pelvis and ureter urothelial carcinoma). * Other severe, acute, or chronic medical or psychiatric disorders, or laboratory abnormalities that, in the investigator's opinion, may increase the risks associated with study participation or that may interfere with the interpretation of the study results.

Primary outcome measure(s)

  • Pathologic complete response (ypCR) at cystectomy — At the time of radical cystectomy (within 18 weeks of the first dose)
    The number of participants with pathologic complete responses (ypCR) at cystectomy. Pathologic complete response is defined as post-treatment stages of T0N0M0 .
  • Safety and tolerability of combination therapy and radical cystectomy — Up to 2 years
    The number of participants experiencing treatment-related adverse events, defined by NCI CTCAE 5.0

Trial sites (5)

FacilityCityRegionStatus
Jiangsu Province Hospital Nanjing Jiangsu Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University Xi'an Shaanxi Recruiting
RenJi Hospital Shanghai Shanghai Municipality Recruiting
West China Hospital Chengdu Sichuan Recruiting
The Second Hospital of Tianjin Medical University Tianjin Tianjin Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06091124 on ClinicalTrials.gov ↗ ← All trials in China