Can a targeted drug combo boost tumor clearance in rare kidney tract cancer?
NCT ID NCT07741448
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
10 sites. The list below names each one and where it is.
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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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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
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Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technolog
RECRUITINGWuhan, Hubei, 430030, China
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Huanggang Central Hospital
RECRUITINGHuanggang, Hubei, 438000, China
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Hubei Cancer Hospital
RECRUITINGWuhan, Hubei, 430079, China
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Jingzhou Central Hospital
RECRUITINGJingzhou, Hubei, 434020, China
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Renmin Hospital of Wuhan University
RECRUITINGWuhan, Hubei, 430060, China
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Taihe Hospital
RECRUITINGShiyan, Hubei, 442000, China
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The Central Hospital of Wuhan
RECRUITINGWuhan, Hubei, 430014, China
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Xiangyang Central Hospital
RECRUITINGXiangyang, Hubei, 441021, China
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Yichang Central People's Hospital
RECRUITINGYichang, Hubei, 443003, China
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Zhongnan Hospital of Wuhan University
RECRUITINGWuhan, Hubei, 430071, China
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