RecruitingNCT06120374

Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC

Safety and Efficacy of Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for Upper Tract Urothelial Carcinoma: An Ambispective Cohort Study

Sponsor

Peking University First Hospital

Enrollment

178 participants

Start Date

Jan 1, 2022

Study Type

OBSERVATIONAL

Conditions

Urothelial Carcinoma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria8

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.

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Interventions

RADIATIONRadiotherapy

For participants eligible for enrollment, radiotherapy was started within 4-6 weeks after surgery. Rotational intensity-modulated radiotherapy (VMAT) with daily image-guided radiotherapy (Daily IGRT) technique was used. Range of irradiation (patients were randomized into two groups - expanded field irradiation group and involved field irradiation group)

DRUGChemotherapy

For patients eligible for enrollment, postoperative adjuvant chemotherapy was initiated at about 4-6 weeks after surgery, for a total of 4 cycles, with the chemotherapy regimen of gemcitabine + cisplatin. Administration: Gemcitabine 1,000 mg/m2 on days 1 and 8 (completed within 30-60 minutes), cisplatin 70 mg/m2 on day 1.

DRUGImmunotherapy

For patients eligible for enrollment, sequential adjuvant immuotherapy was initiated at about 4-6 weeks after surgery, Immunotherapeutic agents include (PD-1/PD-L1) to be used every 21 days postoperatively for one year.