Trial Title:
Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin in Neuroendocrine Bladder Carcinoma
NCT ID:
NCT06091124
Condition:
Neuroendocrine Carcinoma of the Bladder
Bladder Cancer
Conditions: Official terms:
Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Neuroendocrine
Cisplatin
Etoposide
Conditions: Keywords:
Neuroendocrine Carcinoma of the Bladder
Neoadjuvant Therapy
Adebrelimab
Etoposide
Cisplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
Adebrelimab 1200 mg IV on Day 1, once every 3 weeks for up to 4 cycles (each cycle = 21
days)
Arm group label:
Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin Followed by Radical Cystectomy
Other name:
SHR-1316
Other name:
HTI-1088
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Etoposide 0.1g IV on Days 1-3, once every 3 weeks for up to 4 cycles (each cycle = 21
days)
Arm group label:
Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin Followed by Radical Cystectomy
Other name:
VP-16
Other name:
Vepesid
Other name:
Toposar
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin 35mg/m2 IV on Days 1-2, once every 3 weeks for up to 4 cycles (each cycle = 21
days)
Arm group label:
Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin Followed by Radical Cystectomy
Other name:
Cis-Diaminedichloroplatinum
Other name:
CDDP
Intervention type:
Procedure
Intervention name:
Radical Cystectomy
Description:
Radical cystectomy should be performed within 4-6 weeks after completion of last dose
Arm group label:
Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin Followed by Radical Cystectomy
Other name:
RC
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ren Ji Hospital
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
Haige Chen, M.D.
Phone:
86 17702119236
Email:
rjbladder@163.com
Start date:
November 16, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06091124
