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NCT07879469

PHASE2

Antibody-Drug Conjugate Plus Immunotherapy Versus Immunotherapy Plus Chemotherapy for Extensive Transurethrally Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer

Sponsor: Tianjin Medical University Second Hospital

View on ClinicalTrials.gov

Summary

This randomized controlled trial aims to evaluate the efficacy and safety of antibody-drug conjugate (ADC) plus immunotherapy compared with immunotherapy plus chemotherapy in patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC). Patients will be randomly assigned to receive either ADC plus immunotherapy or immunotherapy plus chemotherapy. The study will assess the effectiveness of these two treatment strategies in achieving complete response, maintaining disease control, and preserving the bladder, as well as their safety and tolerability. The findings may help identify an effective bladder-preserving treatment strategy for patients with extensive very-high-risk NMIBC who cannot undergo complete transurethral resection.

Official title: A Randomized Controlled Trial of Antibody-Drug Conjugate Plus Immunotherapy Versus Immunotherapy Plus Chemotherapy in Patients With Extensive Transurethrally Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-10-20

Completion Date

2029-10-01

Last Updated

2026-10-16

Healthy Volunteers

Conditions

Bladder (Urothelial, Transitional Cell) Cancer Antibody-drug Conjugates Immunotherapy Chemotherapy Systemic Therapy

Interventions

DRUG

Disitamab Vedotin and Toripalimab

Disitamab vedotin is a HER2-targeted antibody-drug conjugate. Toripalimab is a monoclonal antibody targeting programmed cell death protein 1 (PD-1). They are administered intravenously every 3 weeks.

DRUG

Toripalimab and Nab-Paclitaxel

Toripalimab is a monoclonal antibody targeting programmed cell death protein 1 (PD-1). Nab-paclitaxel is an albumin-bound formulation of paclitaxel. They are administered intravenously every 3 weeks.

Inclusion Criteria: 1. Patients aged 18 years or older. 2. Histologically confirmed urothelial carcinoma of the bladder, classified as very-high-risk non-muscle-invasive bladder cancer (VHR NMIBC) according to the European Association of Urology (EAU) risk classification. 3. Extensive bladder tumors that cannot be completely resected transurethrally, defined by at least one of the following criteria: * A solitary or confluent tumor with a maximum diameter greater than 5 cm; * Multifocal tumors involving more than 30% of the bladder mucosal surface. * Transurethral unresectability must be independently confirmed by at least two experienced urologists. 4. HER2 expression confirmed by immunohistochemistry (IHC 1+, 2+, or 3+). 5. No prior systemic anticancer therapy for cancer. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 7. Adequate hematologic, hepatic, and renal function to receive the study treatments. 8. Ability to understand the study requirements and willingness to provide written informed consent. Exclusion Criteria: 1. Histologically confirmed muscle-invasive bladder cancer (≥T2), lymph node metastasis, or distant metastasis. 2. Predominantly non-urothelial histology, including pure squamous cell carcinoma, adenocarcinoma, or neuroendocrine carcinoma. 3. Previous treatment with antibody-drug conjugates, immune checkpoint inhibitors, or systemic chemotherapy for bladder cancer. 4. Active autoimmune disease requiring systemic immunosuppressive treatment, or other contraindications to immune checkpoint inhibitor therapy. 5. Active or uncontrolled infection, or other clinically significant uncontrolled medical conditions that may compromise patient safety. 6. Clinically significant peripheral neuropathy or other conditions that would preclude treatment with the study medications. 7. Known severe hypersensitivity to any study medication or its components. 8. Pregnancy or breastfeeding. 9. Concurrent participation in another interventional clinical trial involving investigational anticancer treatment. 10. Any other condition that, in the investigator's judgment, would make participation inappropriate or interfere with the assessment of study outcomes.

Locations (2)

The Second Hospital of Tianjin Medical University

Tianjin, China

Xingtai People's Hospital

Xingtai, China