Fasting-Mimicking Diet Combined With IO-TKI Combination Therapy in Patients With Metastatic Renal… (NCT07500831) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Fasting-Mimicking Diet Combined With IO-TKI Combination Therapy in Patients With Metastatic Renal Cell Carcinoma
China43 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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).
✓. At least one measurable target lesion according to RECIST v1.1 criteria (confirmed by CT or MRI).
✓. Body mass index (BMI) ≥ 20 kg/m².
✓. IMDC intermediate- or poor-risk group.
✓. Willing and able to comply with the fasting-mimicking diet (FMD)protocol,scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
✕. 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).
What they're measuring
1
Incidence and Severity of Adverse Events
Timeframe: From the first administration of fasting-mimicking diet (FMD) combined with anticancer treatment until 40 days after the completion of the last FMD cycle combined with anticancer treatment.
✕. Moderate or high nutritional risk according to the Nutritional Risk Screening (NRS) assessment.
✕. Severe food allergy that prevents the subject from consuming the foods required for the fasting-mimicking diet (FMD).
✕. Symptomatic central nervous system (CNS) metastases, leptomeningeal metastases, or spinal cord compression due to metastases prior to the first dose of study treatment. Exception: Patients with symptomatic CNS metastases who have received treatment and are stable for ≥4 weeks (stable defined as no radiographic progression and resolution of metastasis-related symptoms) and have discontinued systemic corticosteroids (any dose), anticonvulsants, and mannitol for \>2 weeks may be enrolled.
✕. History of other malignancies within 5 years prior to signing the informed consent form (except for cured basal cell skin carcinoma, papillary thyroid carcinoma, etc.).
✕. Active autoimmune disease requiring systemic treatment (e.g., corticosteroids or immunosuppressants) within the past 2 years prior to the first dose of the combination therapy.