An observational study in Metastatic Renal Cell Carcinoma, sponsored by First Affiliated Hospital of Fujian Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by First Affiliated Hospital of Fujian Medical University · Observational
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Among 234 studies in Carcinoma, Renal Cell with a site in China — 111 open to participants now, 142 under way, 10 of them phase 3. Carcinoma, Renal Cell · China.
Among the 234 studies in Carcinoma, Renal Cell with a site in China, this one is the 32nd largest by enrollment of the 45 observational ones that give a count, is one of 6 that started in 2019, is one of 45 observational ones, and was the 226th registered.
2,038 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
Browse Carcinoma, Renal Cell studies →111 of the 234 studies in Carcinoma, Renal Cell with a site in China are open now. Recruiting first, the newest first:
Huazhong University of Science and Technology · Sites in China
Ages 18–80
Zhongnan Hospital · Sites in China
Ages 18+ · Healthy volunteers
RenJi Hospital · Sites in China
Ages 18+
Hangzhou Huasai Biomedicine Co., Ltd. · Sites in China
Ages 18–75
Hebei Medical University Fourth Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 307 Carcinoma, Renal Cell studies recruiting now, 254 (83%) set no upper age limit and 18 (6%) stop at 75 or younger; 20 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
234 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 64 · Phase 2 93 · Phase 3 23 · Phase 4 1
First in 2005; this study’s year is marked. 6 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 228 is above the median of 151 across 337 observational studies indexed under Carcinoma, Renal Cell.
Median enrollment 66 across the 189 interventional studies, 300 across the 45 observational. Of the 57 that completed or were terminated, 14 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
75 of 234 have an industry lead sponsor. The 10 most frequent:
First Affiliated Hospital of Fujian Medical University is the lead sponsor of 97 studies on the registry; 55 are open to participants now.
First Affiliated Hospital of Fujian Medical University has 5 studies filed under Carcinoma, Renal Cell — fewer than ten, so there is no comparison to draw.
35 of the studies in Carcinoma, Renal Cell with a site in China that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03592472Phase 3Xynomic Pharmaceuticals, Inc.A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV) | 2026-12-30 |
| NCT07881900Phase 3Sun Yat-sen UniversityBenmelstobart Plus Anlotinib Versus Sunitinib as First-Line Treatment for Advanced Non-Clear Cell Renal Cell Carcinoma | 2027-06-30 |
| NCT06680089RenJi HospitalCD70-targeted immunoPET Imaging of Kidney Cancer | 2026-11 |
| NCT050242143D Medicines (Sichuan) Co., Ltd.Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors | 2026-12 |
| NCT06852638RenJi HospitalCD70-targeted immunoPET Imaging of Malignant Cancers | 2026-12-23 |
Add all 35 to your calendar (.ics) → With an account.
Among the 234 studies in Carcinoma, Renal Cell with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Pretreatment 18F-FDG PET/CT · Drug: Axitinib Plus Pembrolizumab or Toripalimab
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.
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.
This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.
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.
Time frame: At 12 weeks after initiation of first-line TKI plus ICI therapy
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.
Time frame: From treatment initiation to radiologically confirmed disease progression, death, or last follow-up, assessed up to 24 months
Predictive Performance of the Multi-Lesion Radiomics Model
Discriminative performance of the pretreatment 18F-FDG PET/CT multi-lesion radiomics model for predicting responder status, evaluated using the area under the receiver operating characteristic curve in the training and internal validation cohorts.
Time frame: At 12 weeks after initiation of first-line TKI plus ICI therapy
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Apr 2026, 82 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Fujian Medical University