Bladder (Urothelial, Transitional Cell) CancerPhase 2NCT07879469
Antibody-Drug Conjugate Plus Immunotherapy Versus Immunotherapy Plus Chemotherapy for Extensive Transurethrally Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer
A Phase 2 study testing Disitamab Vedotin and Toripalimab and Toripalimab and Nab-Paclitaxel in people with Bladder (Urothelial, Transitional Cell) Cancer and Antibody-drug Conjugates, run by Tianjin Medical University Second Hospital at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer, Antibody-drug Conjugates, Immunotherapy
- What is being tested?
- Disitamab Vedotin and Toripalimab and Toripalimab and Nab-Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 20 Oct 2026to 1 Oct 2029
- Phase
- Phase 2
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Histologically confirmed muscle-invasive bladder cancer (≥T2), lymph node metastasis, or distant metastasis.
- Predominantly non-urothelial histology, including pure squamous cell carcinoma, adenocarcinoma, or neuroendocrine carcinoma.
- Previous treatment with antibody-drug conjugates, immune checkpoint inhibitors, or systemic chemotherapy for bladder cancer.
- 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.
- Clinically significant peripheral neuropathy or other conditions that would preclude treatment with the study medications.
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- Known severe hypersensitivity to any study medication or its components.
- Pregnancy or breastfeeding.
- Concurrent participation in another interventional clinical trial involving investigational anticancer treatment.
- Any other condition that, in the investigator's judgment, would make participation inappropriate or interfere with the assessment of study outcomes.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
The Second Hospital of Tianjin Medical University
Tianjin, 300000
Hailong Hu, +8613662096232, huhailong@tmu.edu.cn
Xingtai People's Hospital
Xingtai
Junli Wei, MD, +8617212910012, wjluro@163.com
About this study
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
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.
Read the detailed description
Patients with very-high-risk non-muscle-invasive bladder cancer (VHR NMIBC) and extensive tumors that cannot be completely resected transurethrally represent a challenging population with limited bladder-preserving treatment options. Although radical cystectomy is generally recommended for these patients, some are medically unfit for or unwilling to undergo radical surgery. Systemic combination therapies may offer an alternative approach to achieving disease control and preserving the bladder.
Previous studies have demonstrated promising antitumor activity with immunotherapy combined with chemotherapy in this population. Antibody-drug conjugates (ADCs), which enable targeted delivery of cytotoxic agents, have also shown encouraging efficacy in urothelial carcinoma. However, whether ADC plus immunotherapy provides improved antitumor activity compared with immunotherapy plus chemotherapy remains uncertain.
TRUCE-06 is a prospective, multicenter, randomized, open-label, phase II screening trial comparing ADC plus immunotherapy with immunotherapy plus chemotherapy in patients with HER2-expressing, extensive transurethrally unresectable VHR NMIBC. Eligible patients will be randomly assigned in a 1:1 ratio to the two treatment groups.
The primary objective is to compare the complete response rate of high-risk disease between the two treatment strategies. Complete response of high-risk disease is defined as the absence of high-grade Ta, T1, or CIS, without progression to muscle-invasive disease, lymph node or distant metastasis, or death. Treatment response will be evaluated through transurethral resection of bladder tumor (TURBT), imaging, and urine cytology.
In addition to the primary efficacy assessment, the study will evaluate overall complete response, duration of response, progression-free survival, overall survival, safety, patient-reported outcomes, and exploratory biomarkers. The findings may inform the development of future bladder-preserving treatment strategies for patients with extensive VHR NMIBC.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Antibody-drug Conjugates, Immunotherapy, Chemotherapy, Systemic Therapy
- Being tested
- Disitamab Vedotin and Toripalimab, Toripalimab and Nab-Paclitaxel
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin and ToripalimabDrug
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.
Toripalimab and Nab-PaclitaxelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ADC Plus Immunotherapy | Experimental | Participants will receive disitamab vedotin (RC48) plus toripalimab every 3 weeks for four initial treatment cycles. Following response assessment, treatment will continue with disitamab vedotin for up to six additional cycles and toripalimab for up to 20 cycles, according to the study protocol. Receives: Drug: Disitamab Vedotin and Toripalimab |
| Immunotherapy Plus Chemotherapy | Active comparator | Participants will receive toripalimab plus nanoparticle albumin-bound paclitaxel (nab-paclitaxel) every 3 weeks for four initial treatment cycles. Following response assessment, combination treatment may continue for up to 14 cycles, according to the study protocol. Receives: Drug: Toripalimab and Nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate of High-Risk Disease
The proportion of patients achieving complete response of high-risk disease, defined as the absence of high-grade Ta, T1, or carcinoma in situ (CIS), without progression to muscle-invasive bladder cancer, lymph node or distant metastasis, or death. Treatment response will be assessed using transurethral resection of bladder tumor (TURBT), imaging, and urine cytology.
Measured: At the initial response assessment after 4 treatment cycles (approximately 12 weeks)
Secondary outcomes (4)
Progression-Free Survival (PFS)
Time from randomization to disease progression or death from any cause.
Measured: From randomization, assessed up to 2 years
Duration of Response (DOR)
Time from the first documented complete response to disease recurrence, progression, or death, as defined in the protocol.
Measured: From first documented CR, assessed up to 2 years
Overall Complete Response Rate
Proportion of patients achieving complete disappearance of all bladder tumors, including both high-grade and low-grade disease.
Measured: At initial response assessment, approximately 12 weeks
Overall Survival (OS)
Time from randomization to death from any cause
Measured: From randomization, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder (Urothelial, Transitional Cell) CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879469
- Sponsor's protocol ID
- Truce-06
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes