NCT07879469Not yet recruitingPhase 2
Antibody-Drug Conjugate Plus Immunotherapy Versus Immunotherapy Plus Chemotherapy for Extensive Transurethrally Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer
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
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 10 Oct 2026
- Start date
- 20 Oct 2026
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- Tianjin Medical University Second Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT07879469
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From 20 Oct 2026 to the primary completion date, 1 Mar 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Predominantly non-urothelial histology, including pure squamous cell carcinoma, adenocarcinoma, or neuroendocrine carcinoma.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Xingtai People's Hospital Coordinator of this site? Confirm its status | Xingtai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.