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Compares treatment options for Upper Tract Urothelial Carcinoma
Official title Radical Nephroureterectomy With vs Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma (T-LND UTUC)
ClinicalTrials.gov ID: NCT07321210
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if adding a template lymph node dissection (TLND) to the standard surgery for upper tract urothelial cancer (UTUC) can improve patient survival and prevent the cancer from recurrence. The main questions it aims to answer are: Do patients who receive standard surgery with LND live longer without their cancer returning?
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Clinical assessment indicating that the tumor and regional lymph nodes are completely resectable, with at least one of the following high-risk...
- Locally advanced: Preoperative imaging assessed as cT2 stage or higher (i.e., tumor invades muscularis propria or deeper).
You likely can't join if
- 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...
- 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...
- Presence of any active autoimmune disease or history of autoimmune disease.
See the full eligibility criteria
Who can join
- 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:
- Locally advanced: Preoperative imaging assessed as cT2 stage or higher (i.e., tumor invades muscularis propria or deeper).
- High-grade: Preoperative ureteroscopic biopsy pathology confirmed as high-grade urothelial carcinoma (or with squamous differentiation/sarcomatoid differentiation).
- Moderate or severe hydronephrosis: Ipsilateral moderate or severe hydronephrosis due to tumor obstruction.
- Large tumor size: Imaging measures maximum tumor diameter \> 2 cm.
- 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...
- 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...
- Subject voluntarily joins the study, has good compliance, and agrees to undergo safety and survival follow-up.
What rules you out
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.