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Recruiting

NCT Number: NCT07540260

CAIX PET/ CT Guided Radiation Therapy in CcRCC.

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).

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Key information

Conditions

Radiation Therapy Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Metastatic Renal Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Recurrent Renal Cell Cancer Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location status: Recruiting

Location contact

Ronghui Yu

CONTACT

[email protected]

+86-10-83572075

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. PFS

    Time frame: 2 year

    time from the start of treatment to progression

Secondary outcomes

  1. local control rate

    Time frame: 2 year

    local control rate of all irradiated lesions

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mingwei Ma

CONTACT

[email protected]

+86-13693556512

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Acronym: COSTAR-002

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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