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Bladder cancer: a new combo aims to avoid radical surgery

NCT ID NCT07756008

Cure Sponsor: Tianjin Medical University Second Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether combining two drugs—disitamab vedotin and toripalimab—with or without pelvic lymph node removal can help people with muscle-invasive bladder cancer keep their bladder. Participants, who have HER2-positive tumors and decline bladder removal surgery, will receive a procedure to remove the tumor followed by the drug combo. The study compares outcomes between those who also have lymph nodes removed and those who don't, focusing on survival without bladder cancer returning.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
disitamab vedotin (an antibody-drug conjugate) combined with toripalimab (an immunotherapy drug), plus a procedure to remove bladder tumors and, in some patients, pelvic lymph nodes
What this could lead to
If successful, this approach could offer a way to treat muscle-invasive bladder cancer without removing the bladder, potentially preserving quality of life while controlling the disease.
What could go wrong
This is an early-phase trial, so the combination may not work as hoped or could cause significant side effects. The benefit of adding lymph node removal is uncertain and may not improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 114 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female participants aged 18 years or older. 2. Histologically confirmed bladder urothelial carcinoma. 3. Clinical stage cT2-3N0M0 according to the AJCC 8th edition TNM staging system. 4. HER2 expression of IHC 2+ or higher. 5. Participants who decline radical cystectomy as assessed by the investigator. 6. Adequate organ function as defined in the study protocol. 7. Ability to understand and willingness to sign written informed consent. Exclusion Criteria: 1. Known allergy or hypersensitivity to disitamab vedotin, toripalimab, their excipients, or other monoclonal antibodies. 2. Prior radiotherapy for bladder cancer. 3. Prior anticancer treatment that may affect efficacy assessment, as defined in the study protocol. 4. Pregnant or breastfeeding women. 5. Any serious uncontrolled disease or medical condition that, in the investigator's judgment, would make participation inappropriate. 6. Participation in another interventional clinical trial that may interfere with this study.

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma infiltrating bladder urothelial carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer Bladder urothelial carcinoma Muscle invasive bladder cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.