A Phase 2/3 interventional study of Disitamab Vedotin (RC48) and Toripalimab in Bladder Urothelial Carcinoma, Muscle-invasive Bladder Cancer and Bladder Cancer, sponsored by Tianjin Medical University Second Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Tianjin Medical University Second Hospital · Phase 2/3, Interventional, and Treatment
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.
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.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 114 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Tianjin Medical University Second Hospital is the lead sponsor of 60 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab and standardized pelvic lymph node dissection.
Drug: Disitamab Vedotin (RC48) · Drug: Toripalimab · Procedure: Transurethral Resection of Bladder Tumor · Procedure: Pelvic Lymph Node Dissection
Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab without planned pelvic lymph node dissection.
Drug: Disitamab Vedotin (RC48) · Drug: Toripalimab · Procedure: Transurethral Resection of Bladder Tumor
Disitamab vedotin will be administered in combination with toripalimab according to the study protocol.
Toripalimab will be administered in combination with disitamab vedotin according to the study protocol.
Maximal transurethral resection of bladder tumor will be performed as part of the bladder-sparing treatment strategy.
Standardized pelvic lymph node dissection will be performed in participants assigned to the PLND arm.
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.
Time frame: 24 months after randomization
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 months after randomization
Overall Survival
Overall survival is defined as the time from randomization to death from any cause.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From randomization to the end of follow-up, up to 60 months
2-Year Bladder-Intact Event-Free Survival Rate by Baseline HER2 IHC Category
Pretreatment tumor HER2 expression will be assessed by immunohistochemistry and categorized as IHC 2+ or IHC 3+. The percentage of participants meeting the 2-year bladder-intact event-free survival definition will be estimated separately for each HER2 IHC category. Bladder-intact event-free survival is defined as being 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. The unit of measure is percentage of participants.
Time frame: 24 months after randomization
Plan to share: 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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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University Second Hospital