AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Neoadjuvant Gemcitabine Plus Trastuzumab Rezetecan in HER2-positive UTUC

RecruitingPhase 2Ages 18 Years - 75 YearsAllZhiquan Hu
💬

In plain words

What the trial is, and whether it could suit you

Upper tract urothelial carcinoma (UTUC) carries a poor prognosis, with conventional GC (gemcitabine plus cisplatin) regimens achieving only a 19% pathological complete response (pCR) rate in the neoadjuvant setting. Antibody-drug conjugates (ADCs) have shown promising results in advanced urothelial carcinoma, Meanwhile the clinical application of traditional cisplatin-based chemotherapy is associated with significant limitations. Therefore, exploring the efficacy and safety of Trastuzumab Rezetecan (an anti-HER2 ADC) combined with gemcitabine in UTUC is of considerable importance. This trial will enroll patients with HER2 2-3+ UTUC. After pathological diagnosis, patients will receive intravenous infusions of gemcitabine and Trastuzumab Rezetecan. The treatment regimen consists of a 21-day cycle: 4 cycles of neoadjuvant therapy, followed by 2 cycles of adjuvant therapy for patients who d

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
💊

What it tests

  • Trastuzumab Rezetecan
  • Gemcitabine
  • Radical nephroureterectomy
📍

Where

10 sites
Huanggang Central Hospital
Huanggang, China
Jingzhou Central Hospital
Jingzhou, China
Taihe Hospital
Shiyan, China
The Central Hospital of Wuhan
Wuhan, China
Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technolog
Wuhan, China
Renmin Hospital of Wuhan University
Wuhan, China
Zhongnan Hospital of Wuhan University
Wuhan, China
Hubei Cancer Hospital
Wuhan, China

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy