Metastatic Renal Cell CarcinomaNCT07827482
Pretreatment 18F-FDG PET/CT Radiomics for Predicting Response to First-Line Targeted Therapy Plus Immunotherapy in Metastatic Renal Cell Carcinoma
An observational study of Metastatic Renal Cell Carcinoma, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
This single-center retrospective observational study evaluates whether quantitative imaging features from pretreatment 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) can help predict response to first-line tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Pretreatment 18F-FDG PET/CT and Axitinib Plus Pembrolizumab or Toripalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients with pathologically confirmed metastatic renal cell carcinoma who underwent pretreatment 18F-FDG PET/CT and received first-line axitinib plus pembrolizumab or toripalimab at the First Affiliated Hospital of Fujian Medical University. Eligible patients were identified retrospectively from institutional medical and imaging records. The study included patients with adequate clinical, pathological, imaging, treatment response, and follow-up data.
Who may be able to join
- Pathologically confirmed metastatic renal cell carcinoma.
- Pretreatment 18F-FDG PET/CT performed before initiation of first-line systemic therapy.
- Receipt of first-line tyrosine kinase inhibitor plus immune checkpoint inhibitor combination therapy.
- At least one measurable lesion according to RECIST version 1.1.
- Available clinicopathological, imaging, treatment response, and follow-up data.
Who cannot join
- Receipt of systemic anticancer therapy before the pretreatment 18F-FDG PET/CT examination.
- An interval of more than 1 month between pretreatment PET/CT and initiation of first-line systemic therapy.
- Unavailable treatment response assessment or follow-up data.
- Incomplete key clinicopathological or imaging information.
- PET/CT image quality inadequate for lesion segmentation or radiomics analysis.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
About this study
Official title: Application of 18F-FDG PET/CT in Evaluating Treatment Response to Targeted Therapy Plus Immunotherapy in Patients With Metastatic Renal Cell Carcinoma: A Single-Center Retrospective Clinical Study
This single-center retrospective observational study evaluates whether quantitative imaging features from pretreatment 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) can help predict response to first-line tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI) therapy in patients with metastatic renal cell carcinoma.
The study reviews existing medical records and imaging data from 228 patients treated at the First Affiliated Hospital of Fujian Medical University between January 2019 and December 2025. Treatment was selected as part of routine clinical care and was not assigned by the study. Imaging features are extracted separately from the primary kidney tumor and metastatic lesions and are then combined to develop a patient-level multi-lesion radiomics model.
Treatment response is assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 approximately 12 weeks after treatment initiation. Complete response or partial response is classified as response, whereas stable disease or progressive disease is classified as non-response. The study compares imaging-based, clinical, and combined prediction models and also evaluates their association with progression-free survival.
Read the detailed description
Patients with metastatic renal cell carcinoma may have different responses to first-line treatment combining a tyrosine kinase inhibitor with an immune checkpoint inhibitor. Differences may also occur among the primary renal tumor and metastatic lesions within the same patient. Pretreatment 18F-FDG PET/CT provides whole-body information about tumor glucose metabolism, while radiomics can extract quantitative imaging features that may reflect tumor heterogeneity.
This is a single-center retrospective observational cohort study using existing clinical, pathological, treatment, follow-up, and pretreatment 18F-FDG PET/CT data. Eligible patients had pathologically confirmed metastatic renal cell carcinoma, underwent 18F-FDG PET/CT before starting first-line TKI plus ICI therapy, had at least one measurable lesion according to RECIST version 1.1, and had adequate treatment-response and follow-up information. The study did not assign treatment or alter routine clinical care.
Primary renal tumors and eligible metastatic lesions are segmented separately on pretreatment PET/CT images. Conventional metabolic parameters and radiomic features are extracted from each lesion. For patients with multiple metastatic lesions, lesion-level features are aggregated to generate patient-level variables. Primary-tumor, metastatic-lesion, and combined multi-lesion radiomics models are developed. Clinical and metabolic variables are also evaluated, and a combined prediction model is constructed. Patients are divided into training and internal validation cohorts for model development and evaluation.
The primary outcome is treatment response assessed approximately 12 weeks after treatment initiation according to RECIST version 1.1. Complete response and partial response are classified as responder status, while stable disease and progressive disease are classified as non-responder status. Progression-free survival is also evaluated to explore whether the prediction model is associated with longer-term treatment benefit.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Pretreatment 18F-FDG PET/CT, Axitinib Plus Pembrolizumab or Toripalimab
- Keywords
- 18F-FDG PET/CT, Radiomics, Multi-lesion Radiomics, Tyrosine Kinase Inhibitor, Immune Checkpoint Inhibitor, Treatment Response, Progression-Free Survival, Axitinib, Pembrolizumab, Toripalimab
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pretreatment 18F-FDG PET/CTDiagnostic test
Pretreatment 18F-fluorodeoxyglucose positron emission tomography/computed tomography was performed before initiation of first-line systemic therapy. Primary renal tumors and eligible metastatic lesions were evaluated for conventional metabolic parameters and radiomic features.
Axitinib Plus Pembrolizumab or ToripalimabDrug
Patients received first-line axitinib 5 mg orally twice daily combined with either pembrolizumab 200 mg intravenously every 3 weeks or toripalimab 240 mg intravenously every 3 weeks as part of routine clinical care. Treatment was not assigned by the observational study.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Renal Cell Carcinoma Cohort | Patients with pathologically confirmed metastatic renal cell carcinoma who underwent pretreatment 18F-FDG PET/CT and received first-line axitinib plus either pembrolizumab or toripalimab as part of routine clinical care. Clinical, pathological, imaging, treatment response, and follow-up data were retrospectively collected. Treatment was not assigned by the study. Receives: Diagnostic Test: Pretreatment 18F-FDG PET/CT; Drug: Axitinib Plus Pembrolizumab or Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Response According to RECIST Version 1.1
Number and percentage of participants categorized as having complete response, partial response, stable disease, or progressive disease according to Response Evaluation Criteria in Solid Tumors version 1.1. Complete response and partial response are classified as responder status, while stable disease and progressive disease are classified as non-responder status.
Measured: At 12 weeks after initiation of first-line TKI plus ICI therapy
Secondary outcomes (1)
Progression-Free Survival
Progression-free survival is defined as the time from initiation of first-line TKI plus ICI therapy to radiologically confirmed disease progression, death from any cause, or the last available follow-up, whichever occurs first. Participants without progression or death at the last follow-up are censored.
Measured: From treatment initiation to radiologically confirmed disease progression, death, or last follow-up, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Jun 2019
- Primary completion10 Apr 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ning Xu, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827482
- Sponsor's protocol ID
- MRCTA, ECFAH of FMU[2026]810
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the retrospective dataset contains sensitive clinical and imaging information and is subject to institutional privacy, data security, and ethics requirements.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 18F-FDG PET/CT in Evaluating Treatment Response to Targeted Therapy Plus Immunotherapy in Patients With Metastatic Renal Cell Carcinoma: A Single-Center Retrospective Clinical Study
- ClinicalTrials.gov ID
- NCT07827482
- Acronym / sponsor ID
- MRCTA, ECFAH of FMU[2026]810
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- 18F-FDG PET/CT, Radiomics, Multi-lesion Radiomics, Tyrosine Kinase Inhibitor, Immune Checkpoint Inhibitor, Treatment Response, Progression-Free Survival, Axitinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center retrospective observational study evaluates whether quantitative imaging features from pretreatment 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) can help predict response to first-line tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI) therapy in patients with metastatic renal cell carcinoma.
The study reviews existing medical records and imaging data from 228 patients treated at the First Affiliated Hospital of Fujian Medical University between January 2019 and December 2025. Treatment was selected as part of routine clinical care and was not assigned by the study. Imaging features are extracted separately from the primary kidney tumor and metastatic lesions and are then combined to develop a patient-level multi-lesion radiomics model.
Treatment response is assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 approximately 12 weeks after treatment initiation. Complete response or partial response is classified as response, whereas stable disease or progressive disease is classified as non-response. The study compares imaging-based, clinical, and combined prediction models and also evaluates their association with progression-free survival.
Detailed description
Patients with metastatic renal cell carcinoma may have different responses to first-line treatment combining a tyrosine kinase inhibitor with an immune checkpoint inhibitor. Differences may also occur among the primary renal tumor and metastatic lesions within the same patient. Pretreatment 18F-FDG PET/CT provides whole-body information about tumor glucose metabolism, while radiomics can extract quantitative imaging features that may reflect tumor heterogeneity.
This is a single-center retrospective observational cohort study using existing clinical, pathological, treatment, follow-up, and pretreatment 18F-FDG PET/CT data. Eligible patients had pathologically confirmed metastatic renal cell carcinoma, underwent 18F-FDG PET/CT before starting first-line TKI plus ICI therapy, had at least one measurable lesion according to RECIST version 1.1, and had adequate treatment-response and follow-up information. The study did not assign treatment or alter routine clinical care.
Primary renal tumors and eligible metastatic lesions are segmented separately on pretreatment PET/CT images. Conventional metabolic parameters and radiomic features are extracted from each lesion. For patients with multiple metastatic lesions, lesion-level features are aggregated to generate patient-level variables. Primary-tumor, metastatic-lesion, and combined multi-lesion radiomics models are developed. Clinical and metabolic variables are also evaluated, and a combined prediction model is constructed. Patients are divided into training and internal validation cohorts for model development and evaluation.
The primary outcome is treatment response assessed approximately 12 weeks after treatment initiation according to RECIST version 1.1. Complete response and partial response are classified as responder status, while stable disease and progressive disease are classified as non-responder status. Progression-free survival is also evaluated to explore whether the prediction model is associated with longer-term treatment benefit.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Renal Cell Carcinoma Cohort | – | Diagnostic Test: Pretreatment 18F-FDG PET/CT, Drug: Axitinib Plus Pembrolizumab or ToripalimabPatients with pathologically confirmed metastatic renal cell carcinoma who underwent pretreatment 18F-FDG PET/CT and received first-line axitinib plus either pembrolizumab or toripalimab as part of routine clinical care. Clinical, pathological, imaging, treatment response, and follow-up data were retrospectively collected. Treatment was not assigned by the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients with pathologically confirmed metastatic renal cell carcinoma who underwent pretreatment 18F-FDG PET/CT and received first-line axitinib plus pembrolizumab or toripalimab at the First Affiliated Hospital of Fujian Medical University. Eligible patients were identified retrospectively from institutional medical and imaging records. The study included patients with adequate clinical, pathological, imaging, treatment response, and follow-up data.
Key inclusion criteria (5 listed)
- Pathologically confirmed metastatic renal cell carcinoma.
- Pretreatment 18F-FDG PET/CT performed before initiation of first-line systemic therapy.
- Receipt of first-line tyrosine kinase inhibitor plus immune checkpoint inhibitor combination therapy.
- At least one measurable lesion according to RECIST version 1.1.
- Available clinicopathological, imaging, treatment response, and follow-up data.
Key exclusion criteria (5 listed)
- Receipt of systemic anticancer therapy before the pretreatment 18F-FDG PET/CT examination.
- An interval of more than 1 month between pretreatment PET/CT and initiation of first-line systemic therapy.
- Unavailable treatment response assessment or follow-up data.
- Incomplete key clinicopathological or imaging information.
- PET/CT image quality inadequate for lesion segmentation or radiomics analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pretreatment 18F-FDG PET/CTPretreatment 18F-fluorodeoxyglucose positron emission tomography/computed tomography was performed before initiation of first-line systemic therapy. Primary renal tumors and eligible metastatic lesions were evaluated for conventional metabolic parameters and radiomic features. | Diagnostic test | Metastatic Renal Cell Carcinoma Cohort |
| Axitinib Plus Pembrolizumab or ToripalimabPatients received first-line axitinib 5 mg orally twice daily combined with either pembrolizumab 200 mg intravenously every 3 weeks or toripalimab 240 mg intravenously every 3 weeks as part of routine clinical care. Treatment was not assigned by the observational study. | Drug | Metastatic Renal Cell Carcinoma Cohort |
Primary outcome
Treatment Response According to RECIST Version 1.1
Time frame: At 12 weeks after initiation of first-line TKI plus ICI therapy
Number and percentage of participants categorized as having complete response, partial response, stable disease, or progressive disease according to Response Evaluation Criteria in Solid Tumors version 1.1. Complete response and partial response are classified as responder status, while stable disease and progressive disease are classified as non-responder status.
1 secondary outcome
Progression-Free Survival
Time frame: From treatment initiation to radiologically confirmed disease progression, death, or last follow-up, assessed up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the retrospective dataset contains sensitive clinical and imaging information and is subject to institutional privacy, data security, and ethics requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Carcinoma, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Response According to RECIST Version 1.1 (time frame: At 12 weeks after initiation of first-line TKI plus ICI therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.