NCT07500831

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

Fasting-Mimicking Diet Combined With Toripalimab Plus Axitinib for Metastatic or Unresectable Renal Cell Carcinoma: A Single-Arm, Open-Label, Single-Center Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

FMD is a plant-based diet that is low in protein and carbohydrates but higher in healthy fats. For 3 to 7 days at a time, people eat less than 1,100 calories per day. The goal is to copy some of the helpful effects that complete fasting has on slowing cancer cell growth, while avoiding the problems of full fasting such as extreme hunger or malnutrition. In laboratory studies with mice, FMD has been shown to work like water-only fasting to fight tumors. When combined with chemotherapy, immunotherapy, or targeted therapy, it can slow tumor growth and help the mice live longer. For advanced kidney cancer, the usual first treatment is a combination of targeted therapy plus immunotherapy. Researchers want to find out if adding FMD to this standard treatment can help patients live longer and feel better.

Conditions

• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma
• Advanced Renal Cell Carcinoma

Interventions

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

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-01
• Completion: 2029-04-01
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: China