Upper tract urothelial carcinoma, including urothelial carcinoma of the renal pelvis, renal calyces, and ureter
Conditions
Interventions
Holmium Laser Ablation plus Intracavitary Cryoablation Group:Endoscopic Holmium Laser Ablation Combined with Intracavitary Cryoablation
Holmium Laser Ablation Control Group:Endoscopic Holmium Laser Ablation
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Clinically diagnosed ureteral or renal pelvic tumor, with urothelial carcinoma, or a tumor predominantly composed of urothelial carcinoma, confirmed by lesion biopsy or urinary exfoliative cytology within 3 months before screening. 2; 2.No more than two lesions, with the maximum diameter of each lesion not exceeding 3 cm; 3.The participant has a strong preference for kidney-sparing treatment; 4.Male or female participants aged 18 to 80 years; 5.Good general condition, with an Eastern Cooperative Oncology Group performance status of 0–2 and a Karnofsky Performance Status score greater than 40; 6.The participant or the participant’s legally authorized representative is able to understand the study and voluntarily signs the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Preoperative imaging indicates invasion of adjacent organs, the pelvic wall or abdominal wall, corresponding to T3–T4 disease, or the presence of lymph node metastasis (N1–N2) or distant metastasis (M1); 2.The investigator considers that complete lesion ablation cannot be achieved during a single endoscopic procedure, including unresectable concomitant bladder cancer of stage T2 or higher, or lesions located in sites unsuitable for complete endoscopic ablation, such as the lower renal calyx; 3.Receipt of intraluminal chemotherapy, systemic chemotherapy, or immunotherapy within 6 months before enrollment; 4.Presence of severe infectious disease, including bacteremia or toxemia; 5.Decompensated renal insufficiency before surgery, with a glomerular filtration rate below 60 mL/min; 6.Severe coagulation disorder, agranulocytosis, or serious cardiac, cerebral, pulmonary, hepatic, renal, or other disease that makes the participant unable to tolerate surgery or drug treatment; 7.Presence of another malignancy for which treatment was completed less than 2 years previously, except for a prior history of urothelial carcinoma; 8.Severe urethral stenosis, ureteral stenosis, or another condition that prevents or precludes ureteroscopic surgery; 9.Pregnant or breastfeeding women; 10.Positive hepatitis B surface antigen or positive hepatitis C virus antibody; 11.Positive test for human immunodeficiency virus; 12.Presence of a hematologic disorder, including leukemia, lymphoma, myeloma, or myelodysplastic syndrome; 13.Previous bone marrow transplantation, stem cell transplantation, or organ transplantation; 14.Presence of an immunodeficiency disorder or autoimmune disease other than vitiligo; 15.Allergic constitution, particularly a history of hypersensitivity to heterologous proteins; 16.Chronic disease requiring long-term immunosuppressive treatment or systemic corticosteroid therapy, excluding topical or inhaled corticosteroids;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-Month Local Control Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-Year Intravesical Recurrence-Free Survival Rate;3-Month Objective Response Rate;2-Year Recurrence-Free Survival Rate;Incidence of Adverse Events;2-Year Progression-Free Survival Rate; | — |
Countries
China
Contacts
Public ContactHaowen Jiang
Huashan Hospital, Fudan University
Outcome results
None listed