Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC

Peking University

Status: Enrolling

Conditions: Urothelial Carcinoma

Treatments: Radiation: Radiotherapy; Drug: Immunotherapy; Drug: Chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06120374

LUXUS2.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;

Exclusion criteria

• 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.

Trial design

178 participants in 2 patient groups

Adjuvant radioimmunotherapy

Description:

Participants underwent adjuvant radioimmunotherapy

Treatment:

Drug: Immunotherapy

Radiation: Radiotherapy

Adjuvant chemotherapy

Description:

Participants underwent radical total nephroureterectomy and adjuvant chemotherapy

Treatment:

Drug: Chemotherapy