Fasting-Mimicking Diet Combined With IO-TKI Combination Therapy in Patients With Metastatic Renal Cell Carcinoma
NCT07500831 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43
Last updated 2026-03-30
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.
Conditions
- Carcinoma, Renal Cell
- Metastatic Renal Cell Carcinoma
- Advanced Renal Cell Carcinoma
Interventions
- 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 5 mg orally twice daily (BID).
Sponsors & Collaborators
-
Qilu Hospital of Shandong University
lead OTHER
Principal Investigators
-
Nengwang Yu · Qilu Hospital of Shandong University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2028-04-30
- Completion
- 2029-04-30
Countries
- China
Study Locations
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