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NCT Number: NCT07756008

Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer

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.

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Key information

Conditions

Bladder Urothelial Carcinoma Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Muscle-invasive Bladder Cancer Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Disitamab Vedotin (RC48)

Drug

Disitamab vedotin will be administered in combination with toripalimab according to the study protocol.

Toripalimab

Drug

Toripalimab will be administered in combination with disitamab vedotin according to the study protocol.

Transurethral Resection of Bladder Tumor

Procedure

Maximal transurethral resection of bladder tumor will be performed as part of the bladder-sparing treatment strategy.

Pelvic lymph node dissection

Procedure

Standardized pelvic lymph node dissection will be performed in participants assigned to the PLND arm.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical Complete Response Rate

    Time frame: After completion of induction treatment, up to 12 weeks

    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.

  2. Partial Response Rate

    Time frame: After completion of induction treatment, up to 12 weeks

    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.

  3. Disease Progression Rate

    Time frame: Up to 24 months after randomization

    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.

  4. Overall Survival

    Time frame: Up to 60 months after randomization

    Overall survival is defined as the time from randomization to death from any cause.

  5. Incidence and Severity of Adverse Events

    Time frame: From the first dose through 30 days after the last dose, up to approximately 19 months

    The incidence, severity, and relationship to study treatment of adverse events will be assessed according to the Common Terminology Criteria for Adverse Events.

  6. Quality of Life Score

    Time frame: Baseline to 24 months after randomization

    Quality of life will be assessed using the EORTC QLQ-C30 questionnaire according to the study protocol.

  7. Total Treatment Cost

    Time frame: From randomization to the end of follow-up, up to 60 months

    Total treatment cost will be calculated from randomization to the final follow-up according to the study protocol.

Other outcomes

  1. 2-Year Bladder-Intact Event-Free Survival Rate by Baseline HER2 IHC Category

    Time frame: 24 months after randomization

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hailong Hu

CONTACT

[email protected]

+86 13662096232

Peng Li

CONTACT

[email protected]

+86 18935803489

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Second Hospital

Other

Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • The First Affiliated Hospital with Nanjing Medical University

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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