Given the significant challenge of drug resistance in patients with advanced renal cell carcinoma (RCC) despite standard treatment, this study aims to translate preclinical findings into clinical practice, preliminarily evaluating the safety, tolerability, and preliminary efficacy of atorvastatin calcium combined with targeted and immunotherapy in patients with advanced RCC. We hypothesize that for some patients with advanced RCC who do not respond well to targeted + immunotherapy, identifying potential beneficiaries based on their PTC susceptibility testing and combining atorvastatin with these treatments in real-world settings could be an effective susceptibility enhancement strategy, thereby further improving patient survival. This prospective clinical study aims to validate the safety and efficacy of this "organoid-guided precision combination therapy model."
Voluntarily agree to participate in the study and be willing and able to sign the informed consent form.
Histologically confirmed clear cell renal cell carcinoma.
Advanced renal cell carcinoma not suitable for curative surgery or radiotherapy, or metastatic renal cell carcinoma, AJCC stage IV.
No prior systemic therapy for renal cell carcinoma, except for prior adjuvant or neoadjuvant therapy for completely resectable renal cell carcinoma, provided that the therapy did not include agents targeting VEGF or VEGFR and recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.
Prior systemic therapy for renal cell carcinoma, unless the investigator can provide evidence that the participant was assigned to a placebo group.
Known central nervous system metastases.
Active malignancy within the past 24 months, except for renal cell carcinoma, definitively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix or bladder. Participants with a history of localized low-risk prostate cancer may be eligible if they received curative treatment and have had no prostate-specific antigen recurrence within the past 5 years.
Radiotherapy within 21 days before initiation of study treatment, except palliative radiotherapy for bone lesions completed at least 2 weeks before study treatment.
Parallel
Axitinib
DrugAxitinib 5 mg orally twice daily.
Toripalimab
DrugToripalimab 240 mg intravenously every 3 weeks.
Atorvastatin
DrugAtorvastatin calcium 10 mg orally once daily, administered based on patient-derived tumor-like cell cluster drug sensitivity testing.
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who achieve complete response (CR) or partial response (PR) according to RECIST version 1.1.
Progression-Free Survival (PFS)
PFS is defined as the time from treatment initiation to disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Overall Survival (OS)
OS is defined as the time from treatment initiation to death from any cause.
Disease Control Rate (DCR)
DCR is defined as the proportion of participants who achieve complete response, partial response, or stable disease according to RECIST version 1.1.
12-Month Progression-Free Survival Rate
The proportion of participants who remain alive without disease progression at 12 months after treatment initiation.
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