Bladder Urothelial CarcinomaPhase 2/3NCT07756008
Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer
A Phase 2/3 study testing Disitamab Vedotin (RC48), Toripalimab and Transurethral Resection of Bladder Tumor in people with Bladder Urothelial Carcinoma and Muscle-invasive Bladder Cancer, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
This is a prospective, multicenter, randomized controlled superiority study designed to evaluate whether the addition of pelvic lymph node dissection improves bladder-intact event-free survival in patients with cT2-3N0M0 bladder urothelial carcinoma receiving bladder-sparing treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Urothelial Carcinoma, Muscle-invasive Bladder Cancer, Bladder Cancer
- What is being tested?
- Disitamab Vedotin (RC48), Toripalimab and Transurethral Resection of Bladder Tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 20 Jun 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Male or female participants aged 18 years or older.
- Histologically confirmed bladder urothelial carcinoma.
- Clinical stage cT2-3N0M0 according to the AJCC 8th edition TNM staging system.
- HER2 expression of IHC 2+ or higher.
- Participants who decline radical cystectomy as assessed by the investigator.
- Adequate organ function as defined in the study protocol.
- Ability to understand and willingness to sign written informed consent.
Who cannot join
- Known allergy or hypersensitivity to disitamab vedotin, toripalimab, their excipients, or other monoclonal antibodies.
- Prior radiotherapy for bladder cancer.
- Prior anticancer treatment that may affect efficacy assessment, as defined in the study protocol.
- Pregnant or breastfeeding women.
- Any serious uncontrolled disease or medical condition that, in the investigator's judgment, would make participation inappropriate.
- Participation in another interventional clinical trial that may interfere with this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Hailong Hu, MD,PhD, +86 13662096232, huhailong@tmu.edu.cn
Peng Li, +86 18935803489, lipeng990220@tmu.edu.cn
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Study of Disitamab Vedotin Plus Toripalimab With or Without Pelvic Lymph Node Dissection for Bladder-Sparing Treatment in Patients With cT2-3N0M0 Bladder Urothelial Carcinoma
This is a prospective, multicenter, randomized controlled superiority study designed to evaluate whether the addition of pelvic lymph node dissection improves bladder-intact event-free survival in patients with cT2-3N0M0 bladder urothelial carcinoma receiving bladder-sparing treatment. Eligible patients with HER2 expression of IHC 2+ or higher who decline radical cystectomy will be randomized 1:1 to receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab with or without standardized pelvic lymph node dissection. The primary endpoint is the 2-year bladder-intact event-free survival rate. Secondary endpoints include clinical complete response, partial response, disease progression, overall survival, quality of life, safety, treatment cost, and exploratory biomarker analyses.
Read the detailed description
Muscle-invasive bladder cancer is commonly treated with radical cystectomy; however, bladder-sparing strategies are needed for selected patients who decline cystectomy. This study evaluates a bladder-sparing strategy based on maximal transurethral resection of bladder tumor, disitamab vedotin plus toripalimab, and the addition of standardized pelvic lymph node dissection.
Participants will be randomized to receive disitamab vedotin plus toripalimab with or without pelvic lymph node dissection after maximal transurethral resection of bladder tumor. Tumor response will be assessed by imaging, cystoscopy or transurethral resection/biopsy when clinically indicated, and urine cytology. Participants who meet bladder-sparing criteria will enter bladder-intact follow-up according to the protocol. Safety, survival, quality of life, treatment cost, and exploratory biomarkers will also be evaluated.
- Being tested
- Disitamab Vedotin (RC48), Toripalimab, Transurethral Resection of Bladder Tumor, Pelvic Lymph Node Dissection
- Keywords
- Bladder-sparing therapy, Disitamab vedotin, Toripalimab, Pelvic lymph node dissection
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin (RC48)Drug
Disitamab vedotin will be administered in combination with toripalimab according to the study protocol.
ToripalimabDrug
Toripalimab will be administered in combination with disitamab vedotin according to the study protocol.
Transurethral Resection of Bladder TumorProcedure or surgery
Maximal transurethral resection of bladder tumor will be performed as part of the bladder-sparing treatment strategy.
Pelvic Lymph Node DissectionProcedure or surgery
Standardized pelvic lymph node dissection will be performed in participants assigned to the PLND arm.
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection | Experimental | Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab and standardized pelvic lymph node dissection. Receives: Drug: Disitamab Vedotin (RC48); Drug: Toripalimab; Procedure: Transurethral Resection of Bladder Tumor; Procedure: Pelvic Lymph Node Dissection |
| Disitamab Vedotin Plus Toripalimab Without Pelvic Lymph Node Dissection | Active comparator | Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab without planned pelvic lymph node dissection. Receives: Drug: Disitamab Vedotin (RC48); Drug: Toripalimab; Procedure: Transurethral Resection of Bladder Tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Bladder-intact Event-free Survival Rate
The proportion of participants who remain alive with an intact bladder and without muscle-invasive bladder cancer recurrence, regional lymph node recurrence, distant metastasis, radical cystectomy, or bladder cancer-related death at 24 months after randomization.
Measured: 24 months after randomization
Secondary outcomes (7)
Clinical Complete Response Rate
The proportion of participants who achieve clinical complete response, defined as no visible tumor on imaging, no evidence of malignancy on cystoscopy or TURBT/biopsy when clinically indicated, and negative urine cytology. For participants undergoing pelvic lymph node dissection, no lymph node metastasis is required.
Measured: After completion of induction treatment, up to 12 weeks
Partial Response Rate
The proportion of participants with non-muscle-invasive disease, including Ta, T1, or carcinoma in situ, confirmed by urine cytology or pathological biopsy, with no evidence of locally advanced or metastatic disease on imaging.
Measured: After completion of induction treatment, up to 12 weeks
Disease Progression Rate
The proportion of participants with disease progression, defined as muscle-invasive bladder cancer confirmed by pathological biopsy, locally advanced disease, regional lymph node recurrence, distant metastasis, or bladder cancer-related death.
Measured: Up to 24 months after randomization
Overall Survival
Overall survival is defined as the time from randomization to death from any cause.
Measured: Up to 60 months after randomization
Incidence and Severity of Adverse Events
The incidence, severity, and relationship to study treatment of adverse events will be assessed according to the Common Terminology Criteria for Adverse Events.
Measured: From the first dose through 30 days after the last dose, up to approximately 19 months
Quality of Life Score
Quality of life will be assessed using the EORTC QLQ-C30 questionnaire according to the study protocol.
Measured: Baseline to 24 months after randomization
Total Treatment Cost
Total treatment cost will be calculated from randomization to the final follow-up according to the study protocol.
Measured: From randomization to the end of follow-up, up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion20 Jun 2029 (estimated)
- Study completion20 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Urothelial CarcinomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to receive bladder-sparing treatment with disitamab vedotin plus toripalimab with or without standardized pelvic lymph node dissection.
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital with Nanjing Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756008
- Sponsor's protocol ID
- TMU2H-RC48-TORI-MIBC-2026-035
- Status last verified
- Jun 2026
- First submitted
- 27 Jun 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing de-identified individual participant data has not been determined and will be decided after completion of the study, subject to approval by the sponsor, principal investigator, and ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Study of Disitamab Vedotin Plus Toripalimab With or Without Pelvic Lymph Node Dissection for Bladder-Sparing Treatment in Patients With cT2-3N0M0 Bladder Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT07756008
- Acronym / sponsor ID
- TMU2H-RC48-TORI-MIBC-2026-035
- Keywords
- Bladder-sparing therapy, Disitamab vedotin, Toripalimab, Pelvic lymph node dissection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital with Nanjing Medical University
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 20 Jun 2029 (estimated)
- Study completion
- 20 Jun 2031 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, randomized controlled superiority study designed to evaluate whether the addition of pelvic lymph node dissection improves bladder-intact event-free survival in patients with cT2-3N0M0 bladder urothelial carcinoma receiving bladder-sparing treatment. Eligible patients with HER2 expression of IHC 2+ or higher who decline radical cystectomy will be randomized 1:1 to receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab with or without standardized pelvic lymph node dissection. The primary endpoint is the 2-year bladder-intact event-free survival rate. Secondary endpoints include clinical complete response, partial response, disease progression, overall survival, quality of life, safety, treatment cost, and exploratory biomarker analyses.
Detailed description
Muscle-invasive bladder cancer is commonly treated with radical cystectomy; however, bladder-sparing strategies are needed for selected patients who decline cystectomy. This study evaluates a bladder-sparing strategy based on maximal transurethral resection of bladder tumor, disitamab vedotin plus toripalimab, and the addition of standardized pelvic lymph node dissection.
Participants will be randomized to receive disitamab vedotin plus toripalimab with or without pelvic lymph node dissection after maximal transurethral resection of bladder tumor. Tumor response will be assessed by imaging, cystoscopy or transurethral resection/biopsy when clinically indicated, and urine cytology. Participants who meet bladder-sparing criteria will enter bladder-intact follow-up according to the protocol. Safety, survival, quality of life, treatment cost, and exploratory biomarkers will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to receive bladder-sparing treatment with disitamab vedotin plus toripalimab with or without standardized pelvic lymph node dissection.
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection | Experimental | Drug: Disitamab Vedotin (RC48), Drug: Toripalimab, Procedure: Transurethral Resection of Bladder Tumor, Procedure: Pelvic Lymph Node DissectionParticipants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab and standardized pelvic lymph node dissection. |
| Disitamab Vedotin Plus Toripalimab Without Pelvic Lymph Node Dissection | Active comparator | Drug: Disitamab Vedotin (RC48), Drug: Toripalimab, Procedure: Transurethral Resection of Bladder TumorParticipants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab without planned pelvic lymph node dissection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female participants aged 18 years or older.
- Histologically confirmed bladder urothelial carcinoma.
- Clinical stage cT2-3N0M0 according to the AJCC 8th edition TNM staging system.
- HER2 expression of IHC 2+ or higher.
- Participants who decline radical cystectomy as assessed by the investigator.
Key exclusion criteria (6 listed)
- Known allergy or hypersensitivity to disitamab vedotin, toripalimab, their excipients, or other monoclonal antibodies.
- Prior radiotherapy for bladder cancer.
- Prior anticancer treatment that may affect efficacy assessment, as defined in the study protocol.
- Pregnant or breastfeeding women.
- Any serious uncontrolled disease or medical condition that, in the investigator's judgment, would make participation inappropriate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disitamab Vedotin (RC48)Disitamab vedotin will be administered in combination with toripalimab according to the study protocol. | Drug | Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection, Disitamab Vedotin Plus Toripalimab Without Pelvic Lymph Node Dissection |
| ToripalimabToripalimab will be administered in combination with disitamab vedotin according to the study protocol. | Drug | Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection, Disitamab Vedotin Plus Toripalimab Without Pelvic Lymph Node Dissection |
| Transurethral Resection of Bladder TumorMaximal transurethral resection of bladder tumor will be performed as part of the bladder-sparing treatment strategy. | Procedure or surgery | Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection, Disitamab Vedotin Plus Toripalimab Without Pelvic Lymph Node Dissection |
| Pelvic Lymph Node DissectionStandardized pelvic lymph node dissection will be performed in participants assigned to the PLND arm. | Procedure or surgery | Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection |
Primary outcome
2-year Bladder-intact Event-free Survival Rate
Time frame: 24 months after randomization
The proportion of participants who remain alive with an intact bladder and without muscle-invasive bladder cancer recurrence, regional lymph node recurrence, distant metastasis, radical cystectomy, or bladder cancer-related death at 24 months after randomization.
7 secondary outcomes
Clinical Complete Response Rate
Time frame: After completion of induction treatment, up to 12 weeks
Partial Response Rate
Time frame: After completion of induction treatment, up to 12 weeks
Disease Progression Rate
Time frame: Up to 24 months after randomization
Overall Survival
Time frame: Up to 60 months after randomization
Incidence and Severity of Adverse Events
Time frame: From the first dose through 30 days after the last dose, up to approximately 19 months
Quality of Life Score
Time frame: Baseline to 24 months after randomization
Total Treatment Cost
Time frame: From randomization to the end of follow-up, up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing de-identified individual participant data has not been determined and will be decided after completion of the study, subject to approval by the sponsor, principal investigator, and ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Disitamab Vedotin (RC48), Toripalimab and Transurethral Resection of Bladder Tumor in people with Bladder Urothelial Carcinoma and Muscle-invasive Bladder Cancer, run by Tianjin Medical University Second Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hailong Hu (+86 13662096232, huhailong@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Bladder-intact Event-free Survival Rate (time frame: 24 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.