Urinary Bladder CancerPhase 2NCT04861584
Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects
A Phase 2 study testing Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin in people with Urinary Bladder Cancer, run by Zhujiang Hospital at 1 site in China.
Trial summary
This is a pre-surgical study involving subjects with local advanced bladder cancer, who are candidates for neoadjuvant therapy. It is a single-arm phase II portion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urinary Bladder Cancer
- What is being tested?
- Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2021to 3 Apr 2028
- 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
- Patients between 18 and 75 years old on day of signing informed consent, regardless of gender;
- ECOG score 0-1 points, expected survival time> 6 months;
- Pathologically confirmed locally advanced bladder urothelial carcinoma (cT2-T4a, N≤1, M0, tumor staging according to American Joint Committee on Cancer (AJCC), 2017, eighth edition);
- Appropriate and plan for radical cystectomy;
- According to the RECIST1.1 standard, there is at least one measurable lesion (spiral CT scan ≥10mm);
- Since the diagnosis of locally advanced bladder urothelial carcinoma, patient has not received anti-tumor system treatment;
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- The main organ functions are normal, and the following requirements must be met within 2 weeks before the first study treatment:
- Routine blood examination must meet: WBC≥4.0×109/L; PLT≥90×109/L; Hb≥90g/L (patients can be infused with red blood cells to meet this standard);
- Blood biochemical examination must meet: serum creatinine (Cr) ≤1.5 times the upper limit of normal (ULN) or endogenous creatinine clearance ≥60mL/min; TBIL≤1.5×ULN; ALB≥30g/L; ALT and AST≤ 3.0×ULN; TSH≤1.5×ULN.
- Female patients with fertility must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they voluntarily adopt appropriate methods of contraception during the observation period and within 8 weeks after the last administration;
- Agree to provide diagnosis and treatment-related tumor tissue specimens for clinical research, and have the ability to follow the planned research visit until the clinical recurrence/progress is clear.
- Sign informed consent voluntarily.
Who cannot join
- Have previously received anti-PD1/PDL1/CTLA-4 antibody treatment or systemic chemotherapy, bladder infusion chemotherapy is excluded;
- Have received bladder bacille Calmette Guerin (BCG) infusion therapy within 4 weeks;
- Have received radiotherapy of the bladder in the past;
- Patients with any history of active autoimmune disease or autoimmune disease;
- Complicated diseases that require the use of immunosuppressive drugs; concurrent diseases that require the use of immunosuppressive agents for systemic or locally absorbable corticosteroids. It is forbidden to use prednisone greater than 10 mg/day or the same dose in the 2 weeks before the use of the study drug;
- Combined with other malignant tumors;
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- Have a history of allergy to other antibody drugs;
- The history of human immunodeficiency virus (HIV) infection;
- The subject has active infection, including active tuberculosis;
- Combined with severe heart disease, or combined with New York Heart Association (NYHA) grade 3 or 4 cardiac insufficiency;
- Kidney transplant patients;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong, 510282
Peng Xu
About this study
Official title: Phase II Study of Neoadjuvant Toripalimab With Gemcitabine-Cisplatin in Subjects With T2-4aN0M0 Bladder Cancer: GZZJU-2021NB
This is a pre-surgical study involving subjects with local advanced bladder cancer, who are candidates for neoadjuvant therapy. It is a single-arm phase II portion.
Read the detailed description
Outline: This study is a single-arm, open, exploratory clinical trial;
Subjects receive: gemcitabine 1000mg/m2 IV Day1 and Day8 every 21 days repeated for 4 cycles; cisplatin 35mg/m2 IV Day1 and Day2 every 21 days, repeated for 4 cycles.
Toripalimab at recommended phase II dose is given every 3 weeks for 4 doses starting with Cycle1 Day1(C1D1).
Subjects will then have surgery to remove their primary tumor within 6 weeks after their last dose of neoadjuvant therapy.
Eastern Cooperative Oncology Group (ECOG) performance status: 0-1
Demonstrate adequate organ function as defined by the following laboratory values at study entry. All screening labs should be performed within 28 days of C1D1.
Hematopoetic:
Absolute neutrophil count (ANC) ≥1,500 /mcL Absolute lymphocyte count ≥350 mcL Platelets ≥100,000 / mcL Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
Renal: Measured or calculated creatinine clearance ≥30 mL/min
Hepatic:
Serum total bilirubin ≤ 1.25 X ULN OR ≤ 2.5 x ULN for subjects with Gilbert's disease Aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT) ≤ 2 X ULN
Coagulation:
International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy and as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Conditions
- Urinary Bladder Cancer
- Being tested
- Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin
- Keywords
- bladder cancer, checkpoint inhibitor, neoadjuvant therapy
- 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.
Neoadjuvant Toripalimab in Combination With Gemcitabine and CisplatinDrug
Also called Toripalimab
4 cycle neoadjuvant therapy and radical cystectomy
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab+Gemcitabine/Cisplantin（GC） | Experimental | Subjects receive gemcitabine/cisplatin every 21 days, repeated for 4 cycles. . Toripalimab is given every 21 days for 4 doses starting C1D1. Subjects will then have consolidative surgery to remove their primary tumor within 6 weeks after their last dose of neoadjuvant therapy. Receives: Drug: Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response rate evaluated after 4 cycles of neoadjuvant Toripalimab in combination with gemcitabine and cisplatin at time of radical cystectomy, each cycle is 21 days
the absence of residual muscle invasive bladder cancer in surgical specimens of cystectomy (pathologically decreased to ≤pT1N0, including pT0, pT1, pTa and pTis
Measured: Up to 90 days after last dose of investigation product
Secondary outcomes (3)
Safety assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 criteria
To assess safety of Toripalimab in combination with gemcitabine and cisplatin in patients with bladder cancer according to CTCAE v4 criteria
Measured: From the first day of the treatment to the end of neoadjuvant treatment, assessed up to 6 month
Progression-free survival assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
From the start of neoadjuvant therapy to the time when any disease progression is first recorded, disease progression includes the progression detected by clinical or imaging before cystectomy, as well as the distant metastasis or pelvic recurrence after cystectomy. Newly discovered primary tumors in other parts of the urinary tract such as renal pelvis, ureter and urethra are not considered as disease progression.
Measured: From the start of neoadjuvant therapy to the time when any disease progression is first recorded. Assessed lasted for 24 months, calculated from the date of enrolled
Tumor immune microenvironment indicators assessed by Microenvironment Analysis Panel
The expression rate of PDL1 in pathological specimens assessed by Burning Rock's product OncoScreen plus+Microenvironment Analysis Panel at the time of surgery
Measured: Assessed lasted for 24 months, calculated from the date of enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start3 Jun 2021
- Primary completion3 Oct 2027 (estimated)
- Study completion3 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder CancerStudies of the same condition, open and under way.
- More trials run by Zhujiang 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
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abai Xu, Zhujiang Hospital
- Investigators
- Abai Xu, doctor, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861584
- Sponsor's protocol ID
- GZZJU-2021NB
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2021
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant Toripalimab With Gemcitabine-Cisplatin in Subjects With T2-4aN0M0 Bladder Cancer: GZZJU-2021NB
- ClinicalTrials.gov ID
- NCT04861584
- Acronym / sponsor ID
- GZZJU-2021NB
- Conditions
- Urinary Bladder Cancer
- Keywords
- bladder cancer, checkpoint inhibitor, neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 3 Oct 2027 (estimated)
- Study completion
- 3 Apr 2028 (estimated)
- First posted
- 27 Apr 2021 (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.
This is a pre-surgical study involving subjects with local advanced bladder cancer, who are candidates for neoadjuvant therapy. It is a single-arm phase II portion.
Detailed description
Outline: This study is a single-arm, open, exploratory clinical trial;
Subjects receive: gemcitabine 1000mg/m2 IV Day1 and Day8 every 21 days repeated for 4 cycles; cisplatin 35mg/m2 IV Day1 and Day2 every 21 days, repeated for 4 cycles.
Toripalimab at recommended phase II dose is given every 3 weeks for 4 doses starting with Cycle1 Day1(C1D1).
Subjects will then have surgery to remove their primary tumor within 6 weeks after their last dose of neoadjuvant therapy.
Eastern Cooperative Oncology Group (ECOG) performance status: 0-1
Demonstrate adequate organ function as defined by the following laboratory values at study entry. All screening labs should be performed within 28 days of C1D1.
Hematopoetic:
Absolute neutrophil count (ANC) ≥1,500 /mcL Absolute lymphocyte count ≥350 mcL Platelets ≥100,000 / mcL Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
Renal: Measured or calculated creatinine clearance ≥30 mL/min
Hepatic:
Serum total bilirubin ≤ 1.25 X ULN OR ≤ 2.5 x ULN for subjects with Gilbert's disease Aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT) ≤ 2 X ULN
Coagulation:
International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy and as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab+Gemcitabine/Cisplantin（GC） | Experimental | Drug: Neoadjuvant Toripalimab in Combination With Gemcitabine and CisplatinSubjects receive gemcitabine/cisplatin every 21 days, repeated for 4 cycles. . Toripalimab is given every 21 days for 4 doses starting C1D1. Subjects will then have consolidative surgery to remove their primary tumor within 6 weeks after their last dose of neoadjuvant 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)
- Patients between 18 and 75 years old on day of signing informed consent, regardless of gender;
- ECOG score 0-1 points, expected survival time> 6 months;
- Pathologically confirmed locally advanced bladder urothelial carcinoma (cT2-T4a, N≤1, M0, tumor staging according to American Joint Committee on Cancer (AJCC), 2017, eighth edition);
- Appropriate and plan for radical cystectomy;
- According to the RECIST1.1 standard, there is at least one measurable lesion (spiral CT scan ≥10mm);
Key exclusion criteria (11 listed)
- Have previously received anti-PD1/PDL1/CTLA-4 antibody treatment or systemic chemotherapy, bladder infusion chemotherapy is excluded;
- Have received bladder bacille Calmette Guerin (BCG) infusion therapy within 4 weeks;
- Have received radiotherapy of the bladder in the past;
- Patients with any history of active autoimmune disease or autoimmune disease;
- Complicated diseases that require the use of immunosuppressive drugs; concurrent diseases that require the use of immunosuppressive agents for systemic or locally absorbable corticosteroids. It is forbidden to use prednisone greater than 10 mg/day or the same dose in the 2 weeks before the use of the study drug;
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 |
|---|---|---|
| Neoadjuvant Toripalimab in Combination With Gemcitabine and CisplatinAlso: Toripalimab4 cycle neoadjuvant therapy and radical cystectomy | Drug | Toripalimab+Gemcitabine/Cisplantin（GC） |
Primary outcome
Pathological response rate evaluated after 4 cycles of neoadjuvant Toripalimab in combination with gemcitabine and cisplatin at time of radical cystectomy, each cycle is 21 days
Time frame: Up to 90 days after last dose of investigation product
the absence of residual muscle invasive bladder cancer in surgical specimens of cystectomy (pathologically decreased to ≤pT1N0, including pT0, pT1, pTa and pTis
3 secondary outcomes
Safety assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 criteria
Time frame: From the first day of the treatment to the end of neoadjuvant treatment, assessed up to 6 month
Progression-free survival assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
Time frame: From the start of neoadjuvant therapy to the time when any disease progression is first recorded. Assessed lasted for 24 months, calculated from the date of enrolled
Tumor immune microenvironment indicators assessed by Microenvironment Analysis Panel
Time frame: Assessed lasted for 24 months, calculated from the date of enrolled
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 9 Oct 2026.
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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.
Abai Xu, doctor principal investigator
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin in people with Urinary Bladder Cancer, run by Zhujiang Hospital at 1 site 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 11 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Abai Xu, doctor (+86 18665626790, lc96xab@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological response rate evaluated after 4 cycles of neoadjuvant Toripalimab in combination with gemcitabine and cisplatin at time of radical cystectomy, each cycle is 21 days (time frame: Up to 90 days after last dose of investigation product). 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 9 Oct 2026.