Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC
- Conditions
- Urothelial Carcinoma
- Interventions
- Radiation: RadiotherapyDrug: ChemotherapyDrug: Immunotherapy
- Registration Number
- NCT06120374
- Lead Sponsor
- Peking University First Hospital
- Brief Summary
This study is an ambispective cohort observational study to analyze the efficacy of adjuvant radioimmunotherapy (radiotherapy and immunotherapy) compared with adjuvant chemotherapy in patients with the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pT2 and above, N+, G3/high-grade and multiple tumors, positive cut margins). A subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. Patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.
- Detailed Description
This study is an ambispective cohort observational study to analyze the efficacy of adjuvant radioimmunotherapy (radiotherapy and immunotherapy) compared with adjuvant chemotherapy in patients with the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pT2 and above, N+, G3/high-grade and multiple tumors, positive cut margins). A subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. Patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 178
- Confirmed pathologic diagnosis as upper urinary tract urothelial carcinoma(UTUC);
- High-risk UTUC: >= pT2, pN+, tumor G3 grade, multifocality or positive surgical margins (according to AJCC 8th edition);
- Aged >= 18 years old;
- With Distant metastases already found at the time of surgery; non-R0 resected ;
- History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy;
- Pregnant or lactating women; or women of childbearing potential who are not using reliable contraception;
- History of malignant tumors (except skin cancer that is not malignant melanoma and in situ cervical cancer, tumors that have been cured for more than 5 years);
- Weight loss > 10% within 6 months;
- Existing or coexisting bleeding disorders, active infection;
- Terrible condition cannot tolerate the intervention;
- Unable to sign informed consent due to psychological, family, social and other factors.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adjuvant radioimmunotherapy Radiotherapy Participants underwent adjuvant radioimmunotherapy Adjuvant chemotherapy Chemotherapy Participants underwent radical total nephroureterectomy and adjuvant chemotherapy Adjuvant radioimmunotherapy Immunotherapy Participants underwent adjuvant radioimmunotherapy
- Primary Outcome Measures
Name Time Method PFS 1-year, 3-year and 5-year Progression-free Survival
- Secondary Outcome Measures
Name Time Method MFS 1-year, 3-year and 5-year Metastasis free survival
LRFS 1-year, 3-year and 5-year Local recurrence free survival
CSS 1-year, 3-year and 5-year Cancer specific survival
IRFS and CRFS 1-year, 3-year and 5-year intravesical-recurrence free survival and contralateral-recurrence free survival
OS 1-year, 3-year and 5-year Overall survival
Trial Locations
- Locations (3)
Department of Radiotherapy Oncology, Peking University First Hospital
🇨🇳Beijing, China
Department of Medical Oncology, Peking University First Hospital
🇨🇳Beijing, China
Departmeng of Urology, Peking University First Hospital
🇨🇳Beijing, China