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

NCT07756008 | Not Yet Recruiting Phase 2

• 1 other identifier: TMU2H-RC48-TORI-MIBC-2026-035
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bladder Cancer; Bladder Urothelial Carcinoma; Muscle-invasive Bladder Cancer

Keywords

Bladder-sparing therapy; Disitamab vedotin; Toripalimab; Pelvic lymph node dissection

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months after randomization

Secondary Outcomes (7)

• Clinical Complete Response Rate

  After completion of induction treatment, up to 12 weeks

• Partial Response Rate

  After completion of induction treatment, up to 12 weeks

• Disease Progression Rate

  Up to 24 months after randomization

• Overall Survival

  Up to 60 months after randomization

• Incidence and Severity of Adverse Events

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

Other Outcomes (1)

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

  24 months after randomization

Study Arms (2)

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.

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.

Drug: Disitamab Vedotin (RC48); Drug: Toripalimab; Procedure: Transurethral Resection of Bladder Tumor

Interventions

Disitamab Vedotin (RC48) DRUG

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

Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection; Disitamab Vedotin Plus Toripalimab Without Pelvic Lymph Node Dissection

Toripalimab DRUG

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

Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection; Disitamab Vedotin Plus Toripalimab Without Pelvic Lymph Node Dissection

Transurethral Resection of Bladder Tumor PROCEDURE

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

Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection; Disitamab Vedotin Plus Toripalimab Without Pelvic Lymph Node Dissection

Pelvic Lymph Node Dissection PROCEDURE

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

Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator

Study Sites (1)

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

disitamab vedotin; RC48 antibody; toripalimab; Transurethral Resection of Bladder

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Hailong Hu

CONTACT

+86 13662096232; huhailong@tmu.edu.cn

Peng Li

CONTACT

+86 18935803489; lipeng990220@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 to receive bladder-sparing treatment with disitamab vedotin plus toripalimab with or without standardized pelvic lymph node dissection.

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: August 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 20, 2029
• Study Completion (Estimated): June 20, 2031
• Last Updated: August 10, 2026

Record last verified: 2026-06

Locations

CN (1)