This study is testing whether adding a 5-day fasting-mimicking diet (FMD) can help people with advanced kidney cancer when given together with standard first-line cancer medicines.
Subjects voluntarily participate in the study and sign the informed consent form.
Age ≥ 18 years at the time of signing the informed consent form; males or females are eligible.
Pathologically confirmed advanced renal cell carcinoma (metastatic or unresectable) with predominant clear cell histology.
No prior systemic anti-tumor therapy (except for cytokine therapy).
Prior receipt of any systemic anti-tumor therapy for renal cell carcinoma (RCC), including systemic chemotherapy, anti-angiogenic therapy, molecular targeted therapy, immunotherapy containing anti-CTLA-4, anti-PD-1/PD-L1 monoclonal antibodies, and immune checkpoint agonist antibodies (e.g., anti-ICOS, anti-CD40, anti-CD137, anti-GITR, or anti-OX40 antibodies).
Unintentional weight loss ≥5% within the past 3 months, unless the patient has BMI >22 kg/m² and weight loss at study entry is <10%; or unintentional weight loss ≥10% within the past 3 months, unless the patient has BMI >25 kg/m² and weight loss at study entry is <15% (in both cases, body weight must have been stable for at least 1 month prior to study entry).
Body mass index (BMI) <20 kg/m².
Moderate or high nutritional risk according to the Nutritional Risk Screening (NRS) assessment.