Two drug combinations for bladder cancer that surgery through the urethra cannot fully remove
Compares disitamab vedotin with toripalimab against toripalimab with nab-paclitaxel in high-risk bladder cancer.
Plain-language title generated from the registry record
Registry title: Antibody-Drug Conjugate Plus Immunotherapy Versus Immunotherapy Plus Chemotherapy for Extensive Transurethrally Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer
Key facts
- Where
- Tianjin and Xingtai, ChinaSee the 2 sites
- Phase
- Phase 2
Where in China
- The Second Hospital of Tianjin Medical UniversityTianjin, ChinaNo longer taking part
- Xingtai People's HospitalXingtai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tianjin Medical University Second Hospital
- Trial code
- NCT07879469
- Record updated
- 23 October 2026
- Original description
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).Read full original descriptionShow less
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
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.
Inclusion: Patients aged 18 years or older; 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; 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; HER2 expression confirmed by immunohistochemistry (IHC 1+, 2+, or 3+); No prior systemic anticancer therapy for cancer; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Adequate hematologic, hepatic, and renal function to receive the study treatments; Ability to understand the study requirements and willingness to provide written informed consent.
Exclusion: Previous treatment with antibody-drug conjugates, immune checkpoint inhibitors, or systemic chemotherapy for bladder cancer; Clinically significant peripheral neuropathy or other conditions that would preclude treatment with the study medications; Concurrent participation in another interventional clinical trial involving investigational anticancer treatment; Histologically confirmed muscle-invasive bladder cancer (≥T2), lymph node metastasis, or distant metastasis; Active autoimmune disease requiring systemic immunosuppressive treatment, or other contraindications to immune checkpoint inhibitor therapy; Active or uncontrolled infection, or other clinically significant uncontrolled medical conditions that may compromise patient safety; Known severe hypersensitivity to any study medication or its components; Any other condition that, in the investigator's judgment, would make participation inappropriate or interfere with the assessment of study outcomes; Predominantly non-urothelial histology, including pure squamous cell carcinoma, adenocarcinoma, or neuroendocrine carcinoma; Pregnancy or breastfeeding.