CAIX PET/ CT Guided Radiation Therapy in CcRCC. (COSTAR-002)

April 13, 2026 updated by: Peking University First Hospital
This is a prospective, single-arm study in adults with recurrent or metastatic clear cell renal cell carcinoma (ccRCC). Participants will receive standard systemic therapy (targeted therapy plus anti-PD-1 immunotherapy) and undergo dual PET/CT imaging (FDG PET/CT and a CAIX-targeted PET/CT) to map disease sites. When feasible, PET/CT-visible lesions will be treated with image-guided stereotactic ablative radiotherapy (SABR). Patients will be followed to evaluate progression-free survival, local control of treated lesions, and treatment-related adverse events (planned enrollment: ~70).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

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
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital
        • 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

Description

Inclusion Criteria:

Adults (≥18 years) Histologically confirmed clear cell renal cell carcinoma Recurrent or metastatic disease Planned or ongoing first-line systemic therapy (targeted therapy plus anti-PD-1 immunotherapy) Dual PET/CT imaging available (FDG PET/CT and CAIX-targeted PET/CT) and eligible for radiotherapy planning Multidisciplinary assessment confirms radiotherapy is feasible to treat ≥75% of detectable lesions Able to provide written informed consent

Exclusion Criteria:

Unable to receive stereotactic radiotherapy as planned Uncontrolled serious comorbidities or active infection Pregnant or breastfeeding Unable or unwilling to comply with study procedures and follow-up

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mccRCC
Radiation: PETCT-guided radiation therapy
PETCT-guided radiation therapy: All patients will undergo both FDG PET/CT and CAIX PET/CT. Radiotherapy will be planned and delivered based on the imaging findings, with the goal of achieving the most comprehensive feasible (all-site) coverage whenever appropriate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 2 year
time from the start of treatment to progression
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local control rate
Time Frame: 2 year
local control rate of all irradiated lesions
2 year
Duration of current-line systemic therap
Time Frame: From first radiotherapy to change of systemic therapy due to disease progression (up to 3 years).
Time (months) from the start date of the first radiotherapy course to the date when the current-line systemic therapy regimen must be changed due to disease progression. Oligoprogression managed with radiotherapy without changing systemic therapy will not be counted as an event.
From first radiotherapy to change of systemic therapy due to disease progression (up to 3 years).

Collaborators and Investigators

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

Sponsor

Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2025

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COSTAR-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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