Neoadjuvant Radiotherapy for High-risk UTUC

Overview

The investigators propose to conduct an open-label, single-arm, prospective cohort study to collect and observe high-risk UTUC patients (with clear pathology of urothelial carcinoma and at least one of the following (muscle invasion \[cT2 and above\], high-grade tumour, multifocality, tumour diameter of ≥2cm, with hydronephrosis or regional lymph node metastasis) who undergo neoadjuvant therapy(neoadjuvant radiotherapy with/without drug) + radical nephroureterectomy. The cohort was evaluated by regular follow-up for safety and prognosis during the real-world neoadjuvant treatment period, perioperative period, and long-term postoperative follow-up.

The investigators propose to conduct an open-label, single-arm, prospective cohort study to collect and observe high-risk UTUC patients (with clear pathology of urothelial carcinoma and at least one of the following (muscle invasion \[cT2 and above\], high-grade tumour, multifocality, tumour diameter of ≥2cm, with hydronephrosis or regional lymph node metastasis) who undergo neoadjuvant therapy(neoadjuvant radiotherapy with/without drug like chemotherapy, immunotherapy or ADC and etc.) + radical nephroureterectomy. The cohort was evaluated by regular follow-up for safety and prognosis during the real-world neoadjuvant treatment period, perioperative period, and long-term postoperative follow-up. Two cohorts will be enrolled in the project: Cohort 1: high-risk UTUC patients without distant metastases (may be accompanied by regional lymph node metastases) will receive a short course of neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT) after completing a biopsy with a clear pathological diagnosis, and then undergo a radical surgery within 3 months after the completion of the last radiotherapy; Cohort 2: high-risk UTUC patients without distant metastases (may be accompanied by regional lymph node metastases) will receive short course neoadjuvant SBRT after completing a biopsy and making a clear pathological diagnosis. distant metastases (may be accompanied by regional lymph node metastases) of high-risk UTUC patients, who received short-course neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT, naSBRT) + drug therapy after completing biopsy and clear pathological diagnosis, and were treated with radical surgical therapy (full-length radical nephroureterectomy + cystocele sleeve resection) within 3 months from the completion of the last radiotherapy treatment . Drug treatment could be chemotherapy/immunotherapy/ADC treatment etc. Patients in both cohorts were evaluated by physicians after radical surgery for the need of additional adjuvant therapies (including but not limited to chemotherapy/immunotherapy/targeted or other molecular therapies, etc.) for 3 months after surgery based on pathological diagnosis, during which time the patients' adverse reactions and quality of life scores were closely monitored and recorded. Postoperatively, each enrolled patient received regular review (including but not limited to CT, MRI, ultrasound, blood and urine routine, cystoscopy) every 3 months for 2 years after surgery and every 6 months for 3-5 years after surgery, as recommended by current guidelines. When target events including death, local recurrence (including retroperitoneal lymph node metastasis, recurrence in the tumour bed in the operation field, etc.), distant metastasis, bladder recurrence, etc. were observed then the time of the first observation and the corresponding type of event were recorded in detail, and the time interval from the start of the first neoadjuvant radiotherapy was calculated. At the same time, blood routine, lymphocyte typing information, blood and urine specimens, pre-operative biopsies and post-radical surgery pathology specimens were collected during the treatment period for the exploratory study of the corresponding molecular markers to evaluate the characteristics of patients' organism and the tumour immune microenvironment.