UTUC is a cancer that develops in the lining of the kidney or ureter. The standard treatment is radical nephroureterectomy, which removes the kidney and ureter. Although this surgery can control the cancer, it permanently reduces kidney function.
Endoscopic treatment can serve as a kidney-sparing approach for low-risk UTUC; however, in high-risk patients, the high rate of upper tract local recurrence after endoscopic treatment remains the primary failure pattern. This study aims to evaluate the efficacy and safety of radiotherapy-involved kidney-sparing treatment for UTUC.
The main questions this study aims to answer are: Can this multimodal kidney-sparing strategy reduce local recurrence of UTUC compared with endoscopic treatment alone? Participants in the kidney-sparing group will: Undergo endoscopic surgery to remove the tumor; Receive systemic therapy with disitamab vedotin and toripalimab; Receive targeted radiotherapy after surgery.
Participants will undergo regular follow-up visits, including imaging examinations and endoscopic evaluations, to monitor for recurrence or disease progression.
The results of this study may help determine whether a multimodal kidney-sparing treatment strategy could become a safe and effective option for selected patients with high-risk UTUC.
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Patients with clinically histologically confirmed high-risk upper tract urothelial carcinoma who are evaluated and treated at Peking University First Hospital and participating centers will be screened for eligibility. Participants who meet the inclusion criteria and provide informed consent will be enrolled in the kidney-sparing treatment cohort or the radical nephroureterectomy cohort according to clinical decision-making and treatment preference.
Cohort
Prospective
SBRT
RadiationParticipants without confirmed complete tumor resection will receive selective hypofractionated radiotherapy approximately one month after surgery.
One-Year Disease-Free Survival
Disease-free survival is defined as the proportion of participants who remain alive without evidence of local recurrence, upper urinary tract recurrence, intravesical recurrence, disease progression, or distant metastasis.
One-Year kidney-sparing rate
One-Year kidney-sparing rate is defined as the proportion of participants who do not require conversion to radical nephroureterectomy due to disease progression after initial kidney-sparing treatment.
Overall Survival
Overall survival is defined as the time from surgery to death from any cause.
Progression-Free Survival
Progression-free survival is defined as the time from surgery to disease progression or death from any cause.
Local Recurrence-Free Survival
Time from surgery to detection of tumor recurrence at the primary surgical site confirmed by ureteroscopic evaluation.
Intravesical Recurrence-Free Survival
Time from surgery to first documented bladder tumor recurrence confirmed by cystoscopic examination.
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