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New trial: could lymph node removal boost survival in kidney cancer?

NCT ID NCT07321210

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Aug 2032

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.

Ages

18 years and older

Sex

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Tianjin Medical University Second Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300211, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.