Systemic Anti-tumor Activity and Safety of the Combination of SBRT and Concurrent PD-1 Blockade in Metastatic RCC.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Systemic Anti-tumor Activity and Safety of the Combination of SBRT and Concurrent PD-1 Blockade in Metastatic RCC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Response to the Combination of Stereotactic Body Radiation Therapy and Concurrent PD-1 Blockade in Patients With Metastatic Renal Cell Carcinoma: a Retrospective Study
Overview
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).
Primary outcome measures
- Objective Response Rate [Time frame: Up to 2 years.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Nanfang Hospital, Southern Medical University — Guangzhou
Identifiers
NCT: NCT06327178 · NFEC-2023-520