Systemic Anti-tumor Activity and Safety of the Combination of SBRT and Concurrent PD-1 Blockade in Metastatic RCC.

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Systemic Anti-tumor Activity and Safety of the Combination of SBRT and Concurrent PD-1 Blockade in Metastatic RCC

Study type: Observational

Funder types: Other

Identifiers

NCT06327178

NFEC-2023-520

Details and patient eligibility

About

Prior research has indicated that stereotactic body radiotherapy (SBRT) can effectively trigger systemic anti-tumor immune response. The goal of this observational study is to learn about abscopal effects of stereotactic body radiotherapy and concurrent anti-PD-1 antibody treatment in patients of metastatic clear renal cell carcinoma. The primary objective was to assess the objective response rate (ORR) in non-irradiated lesions, and incidence of adverse events (AEs).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age≥18 years at the time of signing informed consent;
• Histologically confirmed, advanced renal cell carcinoma of stage IV (AJCC 8);
• Previously received SBRT and concurrent PD-1 blockade treatment；
• Evidence of measurable metastatic kidney cancer according to RECIST 1.1 criteria.

Exclusion criteria

• Patients who cannot be adequately followed up;
• Has a known additional malignancy that is progressing or requires active treatment.