Neuroendocrine Carcinoma of the BladderPhase 2NEOBLASTNCT06091124
Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin in Neuroendocrine Bladder Carcinoma
A Phase 2 study testing Adebrelimab, Etoposide and Cisplatin in people with Neuroendocrine Carcinoma of the Bladder and Bladder Cancer, run by RenJi Hospital at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuroendocrine Carcinoma of the Bladder, Bladder Cancer
- What is being tested?
- Adebrelimab, Etoposide and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 5 sitesChina
- Study dates
- 16 Nov 2023to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan
Peng Zhang, M.D., 86 28 85422114, Zpeng2001@163.com
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Lyu Qiang, M.D., 86 25 83718836, doctorlvqiang@sina.com
- Recruiting
RenJi Hospital
Shanghai, Shanghai Municipality, 200127
Haige Chen, M.D., 86 17521674856, rjbladder@163.com
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality
Huhai Long, M.D., 86 22 88328832, huhailong@tmu.edu.cn
- Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi
Jinhai Fan, M.D., 86 29 85323112, jinhaif029@126.com
About this study
Official title: A Prospective, Single-arm, Exploratory Study on the Efficacy and Safety of Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin in Patients With Neuroendocrine Bladder Carcinoma
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.
Read the 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.
- Keywords
- Neuroendocrine Carcinoma of the Bladder, Neoadjuvant Therapy, Adebrelimab, Etoposide, Cisplatin
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Also called SHR-1316, HTI-1088
Adebrelimab 1200 mg IV on Day 1, once every 3 weeks for up to 4 cycles (each cycle = 21 days)
EtoposideDrug
Also called VP-16, Vepesid, Toposar
Etoposide 0.1g IV on Days 1-3, once every 3 weeks for up to 4 cycles (each cycle = 21 days)
CisplatinDrug
Also called Cis-Diaminedichloroplatinum, CDDP
Cisplatin 35mg/m2 IV on Days 1-2, once every 3 weeks for up to 4 cycles (each cycle = 21 days)
Radical CystectomyProcedure or surgery
Also called RC
Radical cystectomy should be performed within 4-6 weeks after completion of last dose
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin Followed by Radical Cystectomy | Experimental | 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. Receives: Drug: Adebrelimab; Drug: Etoposide; Drug: Cisplatin; Procedure: Radical Cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (ypCR) at cystectomy
The number of participants with pathologic complete responses (ypCR) at cystectomy. Pathologic complete response is defined as post-treatment stages of T0N0M0 .
Measured: At the time of radical cystectomy (within 18 weeks of the first dose)
Safety and tolerability of combination therapy and radical cystectomy
The number of participants experiencing treatment-related adverse events, defined by NCI CTCAE 5.0
Measured: Up to 2 years
Secondary outcomes (4)
Pathologic downstage at cystectomy
The number of participants with pathological downstage at cystectomy. Pathologic downstage response is defined as downstaged T stage or N stage at cystectomy .
Measured: At the time of radical cystectomy (within 18 weeks of the first dose)
Progression Free Survival
Defined by time from day of first treatment to disease progression
Measured: Up to 2 years
Cancer Specific Survival
Defined by time from day of first treatment to death of the disease
Measured: Up to 2 years
Overall Survival
Defined by time from day of first treatment to death
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start16 Nov 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine Carcinoma of the BladderStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091124
- Sponsor's protocol ID
- IIT-2023-0177
- Acronym
- NEOBLAST
- Status last verified
- Dec 2025
- First submitted
- 14 Oct 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Exploratory Study on the Efficacy and Safety of Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin in Patients With Neuroendocrine Bladder Carcinoma
- ClinicalTrials.gov ID
- NCT06091124
- Acronym / sponsor ID
- NEOBLAST / IIT-2023-0177
- Keywords
- Neuroendocrine Carcinoma of the Bladder, Neoadjuvant Therapy, Adebrelimab, Etoposide, Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin Followed by Radical Cystectomy | Experimental | Drug: Adebrelimab, Drug: Etoposide, Drug: Cisplatin, Procedure: Radical CystectomyThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdebrelimabAlso: SHR-1316, HTI-1088Adebrelimab 1200 mg IV on Day 1, once every 3 weeks for up to 4 cycles (each cycle = 21 days) | Drug | Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin Followed by Radical Cystectomy |
| EtoposideAlso: VP-16, Vepesid, ToposarEtoposide 0.1g IV on Days 1-3, once every 3 weeks for up to 4 cycles (each cycle = 21 days) | Drug | Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin Followed by Radical Cystectomy |
| CisplatinAlso: Cis-Diaminedichloroplatinum, CDDPCisplatin 35mg/m2 IV on Days 1-2, once every 3 weeks for up to 4 cycles (each cycle = 21 days) | Drug | Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin Followed by Radical Cystectomy |
| Radical CystectomyAlso: RCRadical cystectomy should be performed within 4-6 weeks after completion of last dose | Procedure or surgery | Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin Followed by Radical Cystectomy |
Primary outcome
Pathologic complete response (ypCR) at cystectomy
Time frame: 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
Time frame: Up to 2 years
The number of participants experiencing treatment-related adverse events, defined by NCI CTCAE 5.0
4 secondary outcomes
Pathologic downstage at cystectomy
Time frame: At the time of radical cystectomy (within 18 weeks of the first dose)
Progression Free Survival
Time frame: Up to 2 years
Cancer Specific Survival
Time frame: Up to 2 years
Overall Survival
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab, Etoposide and Cisplatin in people with Neuroendocrine Carcinoma of the Bladder and Bladder Cancer, run by RenJi Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haige Chen, M.D. (86 17521674856, rjbladder@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (ypCR) at cystectomy (time frame: At the time of radical cystectomy (within 18 weeks of the first dose)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.