CAIX PET/ CT Guided Radiation Therapy in CcRCC.

NCT07540260 | Recruiting DMC

• 1 other identifier: COSTAR-002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Radiation Therapy; Metastatic Renal Cancer; Recurrent Renal Cell Cancer

Keywords

SBRT; Metastatic Renal Cancer; Recurrent Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  time from the start of treatment to progression

  2 year

Secondary Outcomes (2)

• local control rate

  2 year

• Duration of current-line systemic therap

  From first radiotherapy to change of systemic therapy due to disease progression (up to 3 years).

Study Arms (1)

mccRCC

EXPERIMENTAL

mccRCC

Radiation: PETCT-guided radiation therapy

Interventions

PETCT-guided radiation therapy RADIATION

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.

mccRCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (1)

• Wang HY, Ding HJ, Chen JH, Chao CH, Lu YY, Lin WY, Kao CH. Meta-analysis of the diagnostic performance of [18F]FDG-PET and PET/CT in renal cell carcinoma. Cancer Imaging. 2012 Oct 26;12(3):464-74. doi: 10.1102/1470-7330.2012.0042.

  PMID: 23108238 BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Mingwei Ma

CONTACT

+86-13693556512; drmingweima@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 20, 2026

Record last verified: 2025-11

Locations

CN (1)