Could chemo before surgery beat cancer better?
NCT ID NCT07155044
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study compares giving chemotherapy before surgery versus surgery alone for patients with upper tract urothelial cancer. About 120 participants will be assigned to one of two groups based on their choice and doctor's evaluation. The goal is to see if the chemo-surgery combo leads to better tumor shrinkage and longer 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 and cisplatin (chemotherapy)
- What this could lead to
- If it works, this could show that giving chemotherapy before surgery helps shrink tumors and improve survival for people with upper tract urothelial cancer.
- What could go wrong
- This is a small, non-randomized study at one hospital, so results may not apply to everyone. Chemotherapy has side effects like kidney damage and low blood counts.
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.
- Participants
-
About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2024
- Expected to finish
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May 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.
Who is studied
The study population will consist of adult patients (≥18 years) with histologically confirmed, non-metastatic upper tract urothelial carcinoma (UTUC) who are planned for radical nephroureterectomy (RNU). Participants will be recruited from the urology oncology clinics at a single tertiary care center (e.g., The First Affiliated Hospital of Naval Military Medical University). Eligibility will be determined based on predefined inclusion and exclusion criteria, focusing on patients with adequate renal function (GFR ≥45 mL/min) and performance status (ECOG 0-1) to be potential candidates for cisplatin-based chemotherapy. The population will include both patients who are deemed eligible and choose to receive neoadjuvant chemotherapy prior to surgery and those who proceed directly to surgery.
- Ages
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18 years and older
- Sex
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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 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: * Histologically confirmed upper tract urothelial carcinoma (UTUC). For mixed histology, urothelial carcinoma must be the predominant component (≥50%). * Clinically non-metastatic disease (cN≤1, M0) as determined by cross-sectional imaging (CT or MRI of chest/abdomen/pelvis). * Planned treatment with radical nephroureterectomy (RNU). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate renal function, defined as glomerular filtration rate (GFR) ≥ 45 mL/min, making the patient a potential candidate for cisplatin-based neoadjuvant chemotherapy. * Adequate organ and bone marrow function as determined by standard screening tests. * Recovery from all reversible toxicities of any prior surgery. * Age ≥ 18 years at the time of enrollment. * Ability to understand the study and provide signed informed consent. Exclusion Criteria: * Radiographic evidence of ≥cN2 lymph node disease or distant metastases (M1). * History of invasive, lymph node-positive, or metastatic urothelial carcinoma within 2 years prior to enrollment, or history of invasive contralateral UTUC. * Presence of only a solitary kidney or cisplatin ineligibility. * Concurrent participation in another interventional clinical trial at the time of enrollment. * History of a non-urothelial malignant tumor unless the patient has been disease-free for at least 1 year (exceptions include adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix). * Pregnancy or lactation. Women and men of reproductive potential must agree to use effective contraception. * Any other medical condition, comorbidity, or psychiatric illness that, in the investigator's judgment, would make the patient an unsuitable candidate for the study.
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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.
Contacts and locations
Locations
-
Changhai Hospital
Shanghai, Shanghai Municipality, 200090, China
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