Could a more extensive surgery keep kidney cancer from coming back?
NCT ID NCT07321197
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two surgical approaches for high-risk kidney cancer: a standard limited lymph node removal versus a more thorough 'template' dissection. Researchers want to see if the more extensive surgery helps prevent cancer from returning and improves survival. About 220 participants will be randomly assigned to one of the two procedures and followed for up to 10 years.
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 (surgical procedure)
- What this could lead to
- If successful, this could establish a new standard surgical approach to reduce the risk of kidney cancer returning and improve long-term survival.
- What could go wrong
- This is a relatively early-stage trial with 220 participants, so results may not apply to all patients. The more extensive surgery may carry higher risks of complications like bleeding or infection.
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 220 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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Sep 2033
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 informed consent form. * Age \> 18 years. * Candidate for radical nephrectomy with or without lymph node dissection. * High-risk renal cell carcinoma defined as: At least ONE of: Clinical stage cT3-4 N0-1 M0 (AJCC 8th ed); OR radiologically visible lymph node \>1cm; OR M1 disease rendered no evidence of disease (NED) after local therapy; OR radiologically determined rT4 stage. OR at least TWO of: Renal vein or inferior vena cava tumor thrombus; OR nuclear grade 3-4 or sarcomatoid differentiation or coagulative necrosis; OR tumor size \>= 10cm; OR hematuria and/or local symptoms. * Measurable disease as per RECIST v1.1. * ECOG performance status of 0 or 1. * Adequate bone marrow, renal, and hepatic function. * For women and men of childbearing potential, agreement to use effective contraception during the study period. Exclusion Criteria: * Prior radiotherapy, chemotherapy, major surgery, or targeted therapy for RCC. * Concurrent other active malignancy (except controlled malignancies not affecting 2-year survival). * Candidate for partial nephrectomy or ablation per multidisciplinary team assessment. * Preoperative imaging indicates unresectable regional lymph nodes. * renal tumors or known hereditary RCC syndrome. * Diagnosis of any other active malignancy within the past 5 years. * Active autoimmune disease or history of autoimmune disease. * Use of immunosuppressive agents within 2 weeks prior to enrollment. * Poorly controlled cardiac or clinical symptoms. * Coagulopathy or bleeding tendency. * Active gastrointestinal conditions with risk of bleeding or perforation. * History of significant bleeding or thromboembolic events within specified timeframes. * Active infection or unexplained fever \>38.5°C. * Abdominal fistula, gastrointestinal perforation, or abscess within 4 weeks prior. * History of pulmonary fibrosis, interstitial lung disease, or severely impaired pulmonary function. * Known immunodeficiency or active hepatitis. * Participation in another clinical trial within 1 month. * Known history of drug abuse or alcohol addiction. * Inability or unwillingness to bear the self-paid portion of examination and treatment costs. * Any condition that, in the investigator's judgment, may compromise patient safety or study conduct.
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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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