Fasting-Mimicking Diet Combined With IO-TKI Combination Therapy in Patients With Metastatic Renal Cell Carcinoma

Sponsor
Qilu Hospital of Shandong University
Study ID
NCT07500831
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fasting mimicking diet — DIETARY_SUPPLEMENT
    The 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 — DRUG
    Toripalimab 240 mg IV every 3 weeks (240 mg Q3W) on a 21-day cycle
  • Axitinib — DRUG
    Axitinib 5 mg orally twice daily (BID).

Study Details

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.

Key Dates

First listed
Mar 30, 2026
Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fasting-Mimicking Diet (FMD) Combined with Toripalimab Plus Axitinib
    The fasting-mimicking diet (FMD) is a plant-based dietary regimen that is low in protein and carbohydrates but relatively high in fats. It strictly limits daily caloric intake to less than 1,100 kcal for 3 to 7 consecutive days. The goal of FMD is to replicate the inhibitory effects of complete fasting on tumor cell growth and invasion, while avoiding the side effects associated with full fasting, such as malnutrition and other adverse events.

Primary Outcome Measure

Incidence and Severity of Adverse Events [ Time Frame: 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. ]

Central Contacts

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