Bladder CancerPhase 2NCT07690878
PTC-guided Neoadjuvant Therapy For Muscle-invasive Bladder Cancer
A Phase 2 study testing PTC guided individualized neoadjuvant therapy in people with Bladder Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This study evaluates Patient-derived Tumor-like Cell Clusters (PTC)-guided individualized neoadjuvant therapy in patients with muscle-invasive bladder cancer who are candidates for radical cystectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- PTC guided individualized neoadjuvant therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder, with clinical stage cT2-4aN0M0.
- Medically suitable for radical cystectomy as assessed by the multidisciplinary team.
- Expected survival of at least 18 months.
- Estimated glomerular filtration rate (eGFR) ≥60 mL/min.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- No prior systemic chemotherapy, immunotherapy, targeted therapy, or antibody-drug conjugate therapy for bladder cancer.
Show all 11Show fewer
- Adequate organ and marrow function, including hemoglobin ≥90 g/L, absolute neutrophil count ≥1.5 × 10^9/L, platelet count ≥100 × 10^9/L, potassium 3.5-5.5 mmol/L, ALT and AST ≤1.5 × upper limit of normal, total bilirubin ≤1.5 × upper limit of normal, and left ventricular ejection fraction ≥50%.
- Ability to understand and willingness to sign written informed consent.
- Willingness and ability to comply with study procedures and follow-up.
- Willingness to provide tumor tissue, urine samples, and peripheral blood samples when required for Patient-derived Tumor-like Cell Clusters (PTC) generation, urinary tumor DNA testing, and biomarker analyses.
- Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use medically accepted contraception during study treatment and for 6 months after completion of study treatment. Female participants must not be pregnant or breastfeeding.
Who cannot join
- Non-urothelial carcinoma histology, or mixed histology with a predominant non-urothelial component, such as small cell carcinoma or adenocarcinoma.
- Evidence of distant metastatic disease on imaging.
- Uncontrolled or clinically significant comorbid illness, including but not limited to uncontrolled infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, clinically significant arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhea, or psychiatric/social conditions that may limit compliance or increase study risk.
- Known hypersensitivity or allergy to any study treatment, or history of autoimmune disease.
- Prior exposure to systemic immunotherapy or antibody-drug conjugate therapy, including but not limited to anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies.
- Receipt of a live attenuated vaccine or occurrence of severe infection within 1 month before enrollment.
Show all 10Show fewer
- Use of systemic corticosteroids or other systemic immunosuppressive therapy within 2 weeks before enrollment, or expected need for systemic immunosuppressive therapy during the study.
- Active or symptomatic viral hepatitis or other chronic liver disease, or known human immunodeficiency virus infection.
- Active tuberculosis.
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this study.
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
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
Rong Yang, M.D.&Ph.D., +8613851924716, yangr@nju.edu.cn
About this study
This study evaluates Patient-derived Tumor-like Cell Clusters (PTC)-guided individualized neoadjuvant therapy in patients with muscle-invasive bladder cancer who are candidates for radical cystectomy.
Read the detailed description
This is a single-center, open-label, single-arm clinical study evaluating patient-derived tumor-like cell clusters(PTC)-guided individualized neoadjuvant therapy for patients with muscle-invasive bladder cancer (MIBC). Eligible patients will provide fresh tumor tissue for PTC generation and ex vivo drug sensitivity testing. Based on the PTC results, an individualized neoadjuvant regimen will be selected from chemotherapy, antibody-drug conjugates, anti-PD-1 therapy, or their combinations, followed by radical cystectomy and pelvic lymph node dissection. The primary endpoint is pathological complete response (ypT0N0). Secondary and exploratory endpoints include pathological downstaging, progression-free survival, overall survival and treatment-emergent adverse events.
- Conditions
- Bladder Cancer
- Being tested
- PTC guided individualized 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.
PTC guided individualized neoadjuvant therapyDrug
Fresh tumor tissue will be collected before neoadjuvant treatment to generate Patient-derived Tumor-like Cell Clusters (PTC) for ex vivo drug sensitivity testing. Based on the PTC results, each participant will receive an individualized neoadjuvant regimen selected from gemcitabine plus cisplatin, disitamab vedotin (RC48), enfortumab vedotin, toripalimab, or their protocol-defined combinations. Treatment will be administered for up to 4 cycles before radical cystectomy and pelvic lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Drug: PTC guided individualized neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
Pathological complete response is defined as the proportion of participants with no residual viable tumor in the bladder and no pathological lymph node involvement, defined as ypT0N0, based on pathological assessment of surgical specimens obtained after radical cystectomy and pelvic lymph node dissection.
Measured: immediately evaluated after surgery
Secondary outcomes (4)
Pathological Downstaging (pDS) Rate
Pathological downstaging is defined as the proportion of participants with pathological stage lower than ypT2N0, including ypT0N0, based on surgical pathology after radical cystectomy and pelvic lymph node dissection.
Measured: immediately evaluated after surgery
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from enrollment to disease progression or death from any cause, whichever occurs first.
Measured: From enrollment until disease progression or death, assessed up to 3 years.
Overall Survival (OS)
Overall survival is defined as the time from enrollment to death from any cause.
Measured: From enrollment until death from any cause, assessed up to 3 years.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent adverse events are defined as adverse events occurring after initiation of study treatment, assessed according to CTCAE version 5.0.
Measured: From the first dose of neoadjuvant therapy until the end of safety follow-up, assessed up to 6 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690878
- Sponsor's protocol ID
- 2025-0620-02
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTC-guided Neoadjuvant Therapy For Muscle-invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07690878
- Acronym / sponsor ID
- 2025-0620-02
- Conditions
- Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 8 Jul 2026 (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 study evaluates Patient-derived Tumor-like Cell Clusters (PTC)-guided individualized neoadjuvant therapy in patients with muscle-invasive bladder cancer who are candidates for radical cystectomy.
Detailed description
This is a single-center, open-label, single-arm clinical study evaluating patient-derived tumor-like cell clusters(PTC)-guided individualized neoadjuvant therapy for patients with muscle-invasive bladder cancer (MIBC). Eligible patients will provide fresh tumor tissue for PTC generation and ex vivo drug sensitivity testing. Based on the PTC results, an individualized neoadjuvant regimen will be selected from chemotherapy, antibody-drug conjugates, anti-PD-1 therapy, or their combinations, followed by radical cystectomy and pelvic lymph node dissection. The primary endpoint is pathological complete response (ypT0N0). Secondary and exploratory endpoints include pathological downstaging, progression-free survival, overall survival and treatment-emergent adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: PTC guided individualized neoadjuvant therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder, with clinical stage cT2-4aN0M0.
- Medically suitable for radical cystectomy as assessed by the multidisciplinary team.
- Expected survival of at least 18 months.
- Estimated glomerular filtration rate (eGFR) ≥60 mL/min.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (10 listed)
- Non-urothelial carcinoma histology, or mixed histology with a predominant non-urothelial component, such as small cell carcinoma or adenocarcinoma.
- Evidence of distant metastatic disease on imaging.
- Uncontrolled or clinically significant comorbid illness, including but not limited to uncontrolled infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, clinically significant arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhea, or psychiatric/social conditions that may limit compliance or increase study risk.
- Known hypersensitivity or allergy to any study treatment, or history of autoimmune disease.
- Prior exposure to systemic immunotherapy or antibody-drug conjugate therapy, including but not limited to anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies.
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 |
|---|---|---|
| PTC guided individualized neoadjuvant therapyFresh tumor tissue will be collected before neoadjuvant treatment to generate Patient-derived Tumor-like Cell Clusters (PTC) for ex vivo drug sensitivity testing. Based on the PTC results, each participant will receive an individualized neoadjuvant regimen selected from gemcitabine plus cisplatin, disitamab vedotin (RC48), enfortumab vedotin, toripalimab, or their protocol-defined combinations. Treatment will be administered for up to 4 cycles before radical cystectomy and pelvic lymph node dissection. | Drug | Experimental Group |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: immediately evaluated after surgery
Pathological complete response is defined as the proportion of participants with no residual viable tumor in the bladder and no pathological lymph node involvement, defined as ypT0N0, based on pathological assessment of surgical specimens obtained after radical cystectomy and pelvic lymph node dissection.
4 secondary outcomes
Pathological Downstaging (pDS) Rate
Time frame: immediately evaluated after surgery
Progression-Free Survival (PFS)
Time frame: From enrollment until disease progression or death, assessed up to 3 years.
Overall Survival (OS)
Time frame: From enrollment until death from any cause, assessed up to 3 years.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the first dose of neoadjuvant therapy until the end of safety follow-up, assessed up to 6 months after enrollment.
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 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
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 PTC guided individualized neoadjuvant therapy in people with Bladder Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 11 inclusion and 10 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: opening soon, as of the sponsor's last update on 8 Jul 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 Rong Yang, M.D.&Ph.D. (+8613851924716, yangr@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: immediately evaluated after surgery). 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 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.