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Can a targeted drug combo boost tumor clearance in rare kidney tract cancer?

NCT ID NCT07741448

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial is investigating whether giving a combination of gemcitabine and trastuzumab rezetecan before surgery can improve outcomes for people with HER2-positive upper tract urothelial carcinoma, a rare cancer of the kidney's drainage system. Participants will receive four cycles of the drug combination before their planned surgery, and those without a complete response may receive two additional cycles after surgery. The main goal is to see how often the tumor completely disappears after this pre-surgical treatment, while also monitoring side effects and long-term outcomes like recurrence and survival.

What this could mean

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

Active substance
gemcitabine combined with trastuzumab rezetecan
What this could lead to
If successful, this combination could become a new pre-surgery treatment option for HER2-positive upper tract urothelial carcinoma, potentially improving the chance of eliminating the tumor before surgery and reducing recurrence.
What could go wrong
This is a phase II trial with a modest number of participants, so results may not be definitive. The treatment may cause side effects, and the combination's effectiveness compared to standard care is not yet established.

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 54 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

Aug 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. The subject voluntarily participates in the study, provides written informed consent, and is able to comply with study procedures and follow-up visits. 2. Aged between 18 and 75 years. 3. Patients diagnosed with upper tract urothelial carcinoma (UTUC) who are candidates for radical nephroureterectomy with bladder cuff excision. 4. Clinical stage T1N0M0 - T2-T4aN1M0 (evaluated by CT/MRI/PET-CT). 5. Histopathology confirms urothelial carcinoma as the predominant component; IHC testing shows HER2 expression of 2+ to 3+. 6. ECOG performance status ≤ 2. 7. Laboratory parameters meet all of the following criteria: * Absolute neutrophil count ≥ 1.5 × 10⁹/L * Platelets ≥ 100 × 10⁹/L; hemoglobin ≥ 90 g/L * Total bilirubin ≤ 1.5 × ULN * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 2.5 × ULN; serum creatinine ≤ 3 × ULN 8. Cardiac function: New York Heart Association (NYHA) classification \< Grade III. Exclusion Criteria: 1. Received live attenuated vaccines within 4 weeks prior to enrollment or plan to receive such vaccines during the study. 2. Received systemic chemotherapy, anti-PD-1/PD-L1 agents, or HER2-targeted therapy within the previous 6 months. 3. Known hypersensitivity to gemcitabine, Trastuzumab Rezetecan, or any of their excipients. 4. Active, known or suspected autoimmune disease. 5. Known history of primary immunodeficiency. 6. Known history of solid organ allotransplantation or allogeneic hematopoietic stem cell transplantation. 7. Female patients who are pregnant or breastfeeding. 8. Untreated acute or chronically active hepatitis B or hepatitis C infection. Patients receiving antiviral therapy may be considered eligible at the investigator's discretion with ongoing viral load monitoring. 9. Uncontrolled concurrent illnesses, including but not limited to: 1. HIV infection (positive HIV antibody). 2. Severe active infection with inadequate clinical control. 3. Evidence of severe or uncontrolled systemic disease (e.g., severe psychiatric or neurological disorders, epilepsy or dementia; unstable or decompensated respiratory, cardiovascular, hepatic or renal disease; uncontrolled hypertension defined as CTCAE Grade ≥2 hypertension despite medical treatment). 10. Active bleeding, newly diagnosed thromboembolic disease requiring therapeutic anticoagulation, or bleeding diathesis. 11. Diagnosis of another malignant tumor within the past 5 years. 12. Active tuberculosis

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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 places running it

    10 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

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

    RECRUITING

    Wuhan, Hubei, 430030, China

  • Huanggang Central Hospital

    RECRUITING

    Huanggang, Hubei, 438000, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, 430079, China

  • Jingzhou Central Hospital

    RECRUITING

    Jingzhou, Hubei, 434020, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, 430060, China

  • Taihe Hospital

    RECRUITING

    Shiyan, Hubei, 442000, China

  • The Central Hospital of Wuhan

    RECRUITING

    Wuhan, Hubei, 430014, 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

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