New trial: could lymph node removal boost survival in kidney cancer?
NCT ID NCT07321210
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial is testing whether adding a template lymph node dissection (removing nearby lymph nodes) to the standard surgery for high-risk upper tract urothelial cancer helps patients live longer without the cancer returning. About 150 participants will be randomly assigned to get either standard surgery alone or standard surgery plus lymph node removal. They will be followed for up to 10 years to monitor for recurrence and complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Template Lymph Node Dissection (a surgical procedure to remove lymph nodes during kidney cancer surgery)
- What this could lead to
- If it works, this could show that removing lymph nodes during surgery helps prevent kidney cancer from coming back and improves survival.
- What could go wrong
- This is a relatively small, early-stage trial (150 people). Adding lymph node removal may increase surgery risks or complications without clear benefit.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Aug 2032
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 years and older
- 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: * Signed written informed consent form (ICF). * Age \> 18 years at the time of ICF signing. * Clinical diagnosis of unilateral Upper Tract Urothelial Carcinoma (UTUC) by imaging (enhanced CT or MRI) and/or ureteroscopic biopsy/urinary cytology, and scheduled to undergo Radical Nephroureterectomy (RNU). * Clinical assessment indicating that the tumor and regional lymph nodes are completely resectable, with at least one of the following high-risk features: 1. Locally advanced: Preoperative imaging assessed as cT2 stage or higher (i.e., tumor invades muscularis propria or deeper). 2. High-grade: Preoperative ureteroscopic biopsy pathology confirmed as high-grade urothelial carcinoma (or with squamous differentiation/sarcomatoid differentiation). 3. Moderate or severe hydronephrosis: Ipsilateral moderate or severe hydronephrosis due to tumor obstruction. 4. Large tumor size: Imaging measures maximum tumor diameter \> 2 cm. 5. cN1: Imaging suggests regional lymph node short-axis diameter \> 1 cm, and the investigator judges it to be resectable. * Presence of at least one measurable lesion according to RECIST v1.1 criteria. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function meeting the following requirements (without use of any blood components or colony-stimulating factors within 14 days): Bone marrow function: Neutrophils ≥ 1,500/mm³, Platelets ≥ 100,000/mm³, Hemoglobin ≥ 9 g/dL (5.6 mmol/L). Renal function: Serum creatinine ≤ 1.5 mg/dL and/or Creatinine clearance ≥ 60 mL/min. Liver function: Total bilirubin ≤ 1.5 × ULN, AST \& ALT ≤ 1.5 × ULN. * For women of childbearing potential (WOCBP): Must agree to use a highly effective medically approved contraceptive method during the treatment period and for 3 months after treatment ends. A negative serum or urine pregnancy test within 7 days before enrollment is required; must be non-lactating. For non-sterilized male patients: Must agree to use effective contraception with their partner during the treatment period and for 3 months after treatment ends. * Subject voluntarily joins the study, has good compliance, and agrees to undergo safety and survival follow-up. Exclusion Criteria: * Previous receipt of any anti-tumor therapy for UTUC, including chemotherapy, radiotherapy, immunotherapy, or targeted therapy. * History or concurrent presence of muscle-invasive bladder urothelial carcinoma. * Preoperative imaging assesses regional lymph nodes as unresectable: lymph nodes fused into a massive conglomerate, or fully encasing the abdominal aorta/inferior vena cava/pelvic vessels preventing safe separation. * Known bilateral UTUC or hereditary diseases that definitively increase the risk of contralateral upper tract tumors, such as Lynch Syndrome. * Diagnosis of other active malignancies within the past 5 years (except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix which have been cured and show no recurrence within 5 years). * Presence of any active autoimmune disease or history of autoimmune disease. * Current use of immunosuppressants for immunosuppressive purposes, continued within 2 weeks prior to enrollment. * Poorly controlled cardiac clinical symptoms or diseases. * Coagulation abnormalities or bleeding tendency. * Presence of specific active gastrointestinal conditions or uncontrolled tumor bleeding. * History of significant bleeding, hemoptysis, or thromboembolic events within specified timeframes. * Active infection or unexplained fever \> 38.5°C during screening or before the first dose. * Occurrence of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to surgery. * History or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function, etc. * Congenital or acquired immunodeficiency. * Participation in another clinical study within 1 month prior to enrollment, or potential receipt of other systemic anti-tumor therapy during the study period. * Known history of psychotropic drug abuse, alcohol abuse, or drug use. * Inability or unwillingness to bear the out-of-pocket costs of examinations and treatments. * Any other condition deemed by the investigator to make the subject unsuitable for participation.
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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
1 site. 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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Tianjin Medical University Second Hospital
RECRUITINGTianjin, Tianjin Municipality, 300211, China
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