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

NCT ID: NCT06327178

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guozhu Xie

Role: CONTACT

02062787693

Facility Contacts

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Guozhu Xie

Role: primary

Other Identifiers

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NFEC-2023-520

Identifier Type: -

Identifier Source: org_study_id

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