Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Nov 2, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two treatment options for patients with high-risk upper urinary tract urothelial carcinoma (UTUC), a type of cancer that affects the urinary system. Specifically, the study compares adjuvant radioimmunotherapy, which combines radiotherapy and immunotherapy, to traditional adjuvant chemotherapy. The goal is to see which treatment is more effective in preventing the cancer from coming back after surgery. They are particularly interested in patients who have certain high-risk factors, such as advanced tumor stage or positive surgical margins, which could indicate a higher chance of recurrence.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of high-risk UTUC, but they cannot have distant cancer spread or certain other health issues. If eligible, participants will receive one of the two treatment options and will be monitored closely to see how well they respond. The trial is currently recruiting participants, and it’s important for eligible patients to discuss this opportunity with their healthcare provider to understand more about potential benefits and any risks involved.

Gender

ALL

Eligibility criteria

• 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.