Radical Nephroureterectomy With vs Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma (T-LND UTUC)

Korábbi kezelés

• 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.
• Current use of immunosuppressants for immunosuppressive purposes, continued within 2 weeks prior to enrollment.
• Occurrence of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to surgery.
• Participation in another clinical study within 1 month prior to enrollment, or potential receipt of other systemic anti-tumor therapy during the study period.

Más betegség

• 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.
• 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.
• History or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function, etc.
• Known history of psychotropic drug abuse, alcohol abuse, or drug use.
• Any other condition deemed by the investigator to make the subject unsuitable for participation.

Egyéb

• 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.
• Congenital or acquired immunodeficiency.
• Inability or unwillingness to bear the out-of-pocket costs of examinations and treatments.

• 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, 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.