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.
Single group
Fasting mimicking diet
Dietary supplementThe fasting-mimicking diet (FMD) consists of a 5-day regimen: day 1 supplies 600 kcal (10-17% protein, 30-35% fat, 51-59% carbohydrate), days 2-5 are identical in formulation and provide 300 kcal (11-17% protein, 73-77% fat, 8-12% carbohydrate).
Toripalimab
DrugToripalimab 240 mg IV every 3 weeks (240 mg Q3W) on a 21-day cycle
Axitinib
DrugAxitinib 5 mg orally twice daily (BID).
Incidence and Severity of Adverse Events
Incidence and severity of treatment-emergent adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Progression-Free Survival (PFS)
Progression-free survival assessed according to RECIST version 1.1 and iRECIST criteria.
Objective Response Rate (ORR)
Objective response rate assessed according to RECIST version 1.1 and iRECIST criteria.
Duration of Response (DOR)
Duration of response assessed according to RECIST version 1.1 and iRECIST criteria.
Disease Control Rate (DCR)
Disease control rate assessed according to RECIST version 1.1 and iRECIST criteria.
Changes in Gut Microbiota and Correlations with Metabolic Biomarkers
Exploratory evaluation of changes in intestinal (gut) microbiota in patients with renal cell carcinoma after fasting-mimicking diet (FMD) treatment, and the correlations among gut microbiota changes, blood metabolic biomarkers, and treatment with FMD combined with toripalimab plus axitinib.
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This trial is not recruiting at the moment. You can still explore other options:
