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

May 21, 2025 updated by: Nanfang Hospital, Southern Medical University

Response to the Combination of Stereotactic Body Radiation Therapy and Concurrent PD-1 Blockade in Patients With Metastatic Renal Cell Carcinoma: a Retrospective Study

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).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced metastatic clear cell renal cell carcinoma who have received SBRT and concurrent PD-1 blockade treatment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: Up to 2 years.
Up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

April 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 25, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2023-520

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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