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New drug cocktail aims to wipe out bladder cancer before surgery

NCT ID NCT07693959

Disease control Sponsor: Zhiquan Hu Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether combining the targeted drug disitamab vedotin (RC48) with chemotherapy (gemcitabine) before surgery works as well as RC48 plus an immunotherapy (toripalimab) for people with HER2-positive muscle-invasive bladder cancer. Participants receive one of the two combos for 3–6 cycles, then undergo bladder removal surgery. The main goal is to see how many patients have no cancer left in the removed tissue. The study also tracks side effects and long-term outcomes.

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 (RC48) and gemcitabine
What this could lead to
If successful, this combination could become a standard pre-surgery treatment for HER2-positive muscle-invasive bladder cancer, potentially increasing the chance of eliminating all cancer before surgery.
What could go wrong
This is an early-phase comparison; the experimental arm may not prove superior or even non-inferior to the comparator. Side effects from chemotherapy and targeted therapy can be significant.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 170 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

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 to 75 years

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. Informed Consent \& Compliance: Provision of signed informed consent and ability to comply with study procedures and follow-up requirements. 2. Age: Age 18 to 75 years (inclusive). 3. Planned Surgery: Planned to undergo radical cystectomy (RC) with lymph node dissection (LND). 4. Clinical Stage: Clinical stage T2-T4aNxM0, as assessed by CT, MRI, or PET-CT. 5. Pathology \& Biomarker: Histologically confirmed predominant urothelial carcinoma by cystoscopic biopsy or transurethral resection of bladder tumor (TURBT), with HER2 expression of 1+ to 3+ determined by immunohistochemistry (IHC). 6. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. 7. Adequate Organ Function: Laboratory values meeting the following criteria: Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; Platelet count ≥ 100 × 10\^9/L; Hemoglobin ≥ 80 g/L; Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × ULN 8. Cardiac Function: New York Heart Association (NYHA) class \< 3. 9. Reproductive Status \& Contraception: \*Female: Must be surgically sterile, postmenopausal, or agree to use highly effective contraception during the study and for 6 months after the last dose of study treatment. Must not be lactating. \*Male: Must agree to use a medically acceptable method of contraception (e.g., condoms, abstinence) during the study and for 6 months after the last dose of study treatment. Exclusion Criteria： 1. Receipt of live attenuated vaccine within 4 weeks prior to enrollment or planned receipt during the study period. 2. Receipt of systemic chemotherapy, or anti-PD-1, anti-PD-L1, or HER2-targeted therapy within the past 6 months. 3. Known hypersensitivity to gemcitabine, disitamab vedotin, toripalimab, or any of their excipients. 4. Active, known, or suspected autoimmune disease. 5. Known history of primary immunodeficiency. 6. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 7. Untreated acute or chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. (Patients receiving continuous antiviral therapy with monitored viral loads may be eligible at the investigator's discretion). 8. Uncontrolled concurrent illness including, but not limited to: human immunodeficiency virus (HIV) infection, active or poorly controlled severe infection, or evidence of uncontrolled systemic disease (e.g., severe psychiatric/neurological disorders, decompensated respiratory failure). 9. History of other malignancies within the past 5 years, excluding clinically cured early-stage tumors. 10. Active tuberculosis.

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma

As listed by the trial registrant

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

MIBC

How to take part

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

  1. The places running it

    22 sites. 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

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    RECRUITING

    Shenzhen, Guangdong, 518117, China

  • Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430030, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Huanggang Central Hospital

    RECRUITING

    Huanggang, Hubei, 438000, China

  • Huangshi Central Hospital

    RECRUITING

    Huangshi, Hubei, 435000, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, 430079, China

  • Jiangxi Provincial People's Hospital

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • Jingmen Central Hospital

    RECRUITING

    Jingmen, Hubei, 448000, China

  • Jingzhou Central Hospital

    RECRUITING

    Jingzhou, Hubei, 434020, China

  • Jingzhou First People's Hospital

    RECRUITING

    Jingzhou, Hubei, 434000, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, 430060, China

  • Shandong Cancer Hospital and Institute

    RECRUITING

    Jinan, Shandong, 250117, China

  • Taihe Hospital

    RECRUITING

    Shiyan, Hubei, 442000, China

  • The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture

    RECRUITING

    Enshi, Hubei, 445000, China

  • The Central Hospital of Wuhan

    RECRUITING

    Wuhan, Hubei, 430014, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

  • Wuhan No.1 Hospital

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Xiangyang Central Hospital

    RECRUITING

    Xiangyang, Hubei, 441021, China

  • Yichang Central People's Hospital

    RECRUITING

    Yichang, Hubei, 443003, China

  • Zhongnan Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, 430071, China

  • Zhujiang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510280, China

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