- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06327178
Abscopal Effects of Stereotactic Body Radiotherapy in Metastatic Clear Renal Cell Carcinoma
March 24, 2024 updated by: Nanfang Hospital, Southern Medical University
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 in patients of metastatic clear renal cell carcinoma.
The primary objective was to assess the objective response rate (ORR) and complete response (CR) in non-irradiated lesions, and incidence of adverse events (AEs).
Study Overview
Status
Recruiting
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
- Name: Guozhu Xie
- Phone Number: 02062787693
- Email: xieguozhu@126.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510515
- Recruiting
- Nanfang Hospital, Southern Medical University
-
Contact:
- Guozhu Xie
- Email: xieguozhu@126.com
-
-
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 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 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.
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)
January 31, 2024
Study Completion (Estimated)
April 30, 2024
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)
March 26, 2024
Last Update Submitted That Met QC Criteria
March 24, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
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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