PTC-guided Neoadjuvant Therapy For Muscle-invasive Bladder Cancer

NCT07690878 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-0620-02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  immediately evaluated after surgery

Secondary Outcomes (4)

• Pathological Downstaging (pDS) Rate

  immediately evaluated after surgery

• Progression-Free Survival (PFS)

  From enrollment until disease progression or death, assessed up to 3 years.

• Overall Survival (OS)

  From enrollment until death from any cause, assessed up to 3 years.

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  From the first dose of neoadjuvant therapy until the end of safety follow-up, assessed up to 6 months after enrollment.

Study Arms (1)

Experimental Group

EXPERIMENTAL

Drug: PTC guided individualized neoadjuvant therapy

Interventions

PTC guided individualized neoadjuvant therapy DRUG

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.

Experimental Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Rong Yang, M.D.&Ph.D.

CONTACT

+8613851924716; yangr@nju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)