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Promising combo aims to shrink bladder tumors before surgery

NCT ID NCT07639983

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether combining two drugs (trastuzumab rezetecan and camrelizumab) before surgery can improve outcomes for people with a certain type of muscle-invasive bladder cancer (HER2-positive). About 44 adults will receive the treatment to see if it helps eliminate cancer cells or shrink tumors enough to avoid bladder removal. The goal is to find a more effective and tolerable option than standard chemotherapy.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 44 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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. Aged ≥18 years old with no restriction on gender. 2. Voluntarily participate in this trial, sign written informed consent form and have good treatment compliance. 3. Histopathologically confirmed bladder urothelial carcinoma (carcinoma with squamous/glandular differentiation is acceptable only when urothelial component dominates the lesion). 4. Clinically or radiologically diagnosed muscle-invasive bladder cancer (MIBC): cT2-T4a, N0-1, M0 per AJCC/UICC staging system; all imaging assessments shall be completed within 28 days prior to enrollment. 5. HER2-positive tumor defined as IHC 1+, 2+ or 3+ tested on archival tumor specimen before enrollment via designated or central laboratory. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7. Candidates eligible for radical surgery: planned to receive radical cystectomy (RC), and investigators confirm feasibility of subsequent TURBT consistent with study protocol. 8. Satisfactory major organ function to tolerate perioperative treatment: * Hematology: ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L; * Liver function: ALT/AST ≤2.5×ULN, total bilirubin ≤1.5×ULN; * Renal function: creatinine clearance ≥50 mL/min calculated by Cockcroft-Gault or MDRD formula; * Cardiac function: LVEF ≥50% detected by echocardiography without symptomatic heart failure (due to trastuzumab-related cardiac risk). 9. Fertile subjects agree to use effective contraception throughout study period and for defined duration after last study drug administration. Exclusion Criteria: 1. Patients with distant metastasis (M1), unresectable disease ineligible for radical surgery, or concomitant active malignancy requiring systematic anti-tumor therapy as assessed by investigator. 2. Prior systemic anti-tumor therapy for current bladder cancer, including neoadjuvant/adjuvant/metastatic chemotherapy, immunotherapy or anti-HER2 agents; previous exposure to PD-1/PD-L1 inhibitors, anti-HER2 monoclonal antibodies or ADCs that may interfere with efficacy or safety evaluation per investigator's judgment. 3. Previous pelvic radiotherapy, or unrecovered major surgery/severe trauma within predefined time window before enrollment. 4. Active autoimmune disease or patients requiring long-term systemic immunosuppressive therapy (daily prednisone\>10 mg or equivalent dose; topical/inhaled/short-course steroid use is permitted). 5. Uncontrolled active or severe bacterial infection, active tuberculosis; viral infection: HBsAg positive with elevated HBV DNA without standardized antiviral treatment, positive HCV RNA without disease control, or confirmed HIV infection per local institutional standard; clinically significant cardiovascular disorders including congestive heart failure, recent myocardial infarction, unstable angina, uncontrolled arrhythmia, baseline LVEF\<50%, or subjects inappropriate for trastuzumab administration judged by investigator. 6. Previous or ongoing interstitial lung disease/non-infectious pneumonitis, or obvious interstitial pulmonary changes on imaging with high risk of immune-related pneumonitis assessed by investigator. 7. Known severe hypersensitivity to trastuzumab, camrelizumab or any excipients of investigational drugs; pregnant or breastfeeding females, or those planning pregnancy throughout study period. 8. Severe psychiatric/cognitive disorder or substance abuse preventing regular follow-up and efficacy assessment. 9. Any other conditions inappropriate for trial enrollment such as severe comorbidities or extremely short expected survival, as determined by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The official record

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

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  2. A doctor treating you

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More trials for these conditions

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