Upper urinary tract urothelial carcinoma
Conditions
Interventions
Study group:Cryoablation plus laser resection through ureteroscopic, percutaneous nephrological, Nephroureterectomy+ bladder sleeve resection, adjuvant GC chemotherapy
Control group:Nephroureterectomy+ bladder sleeve resection
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1)Patients that are clinically diagnosed with upper urinary tract tumor based on imaging or pathologically diagnosed with urothelial carcinoma by biopsy of lesion tissue through ureterorenoscopy; or suspected of urothelial carcinoma by urine exfoliated cells obtained through ureterorenoscopy;(2)Patients that have a strong will to preserve kidneys;(3)Male or female, aged 18 to 85 years;(4)Patients in good general conditions with ECOG score 1-2 points (Karnofsky score>40);(5)Patients that understand the nature of the procedure and provides written informed consent;
Exclusion criteria
Exclusion criteria: (1)Clinical diagnosis of peripheral organ invasion, pelvic or abdominal wall involvement, or lymph node metastasis (N1) /distant metastasis (M1); (2)Patients who have situations that researchers believe lesions cannot be removed in a single surgery, including:1) The number of tumor sites is more than 3; 2) The length or diameter of lesion is greater than 3cm; 3)Lesions are located in the Inferior calyces of kidney;(3)Patients that are allergic to immune checkpoint inhibitor and/or chemotherapy drugs;(4)Patients who received bladder instillation chemotherapy, systemic chemotherapy or immunotherapy within the 6 months prior to enrollment;(5)Patients accompanied by severe infectious diseases such as bacteraemia or toxaemia;(6)Patients who have severe coagulopathy and/or granulocyte deficiency(Platelets 2.5 ULN or total bilirubin >1.5 ULN or glomerular filtration rate <20ml/hour);(8)Patients who have other malignancies (except for a previous personal history of urothelial carcinoma);(9)Pregnancy or lactation;(10)Patients having complications such as severe urethral strictures that cannot tolerate ureteroscopic surgery;(11)Patients enrolled in any other trial during the same period;(12) Patients who have any other conditions that are not appropriate for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate at 3 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor recurrence rate at 2 years after surgery;Overall survival rate at 2 years and 5 years after surgery;Progression-free survival rate at 2 years and 5 years after surgery;Adverse Event incidence after surgery;Quality of life scores;Quality-adjusted life years; | — |
Countries
China
Contacts
Public ContactHaowen Jiang
Department of Urology, Huashan Hospital Affiliated to Fudan University
Outcome results
None listed