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

NCT07500831 | Not Yet Recruiting

• 1 other identifier: KYLL-2025-10-006-1
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  3 years

• Objective Response Rate (ORR)

  3 years

• Duration of Response (DOR)

  3 years

• Disease Control Rate (DCR)

  3 years

• Overall Survival (OS)

  3 years

Other Outcomes (1)

• Changes in Gut Microbiota and Correlations with Metabolic Biomarkers

  Up to 12 months (from baseline until completion of the last FMD cycle)

Study Arms (1)

Fasting-Mimicking Diet (FMD) Combined with Toripalimab Plus Axitinib

EXPERIMENTAL

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.

Dietary Supplement: Fasting mimicking diet; Drug: Toripalimab; Drug: Axitinib

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).

Fasting-Mimicking Diet (FMD) Combined with Toripalimab Plus Axitinib

Toripalimab DRUG

Toripalimab 240 mg IV every 3 weeks (240 mg Q3W) on a 21-day cycle

Also known as: Tuoyi

Fasting-Mimicking Diet (FMD) Combined with Toripalimab Plus Axitinib

Axitinib DRUG

Axitinib 5 mg orally twice daily (BID).

Also known as: Inlyta

Fasting-Mimicking Diet (FMD) Combined with Toripalimab Plus Axitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Able to maintain daily contact with the investigator (via telephone or email) to communicate key clinical information, including daily body weight, blood pressure, health status, and adverse events during the 5-day FMD period.
• Low nutritional risk according to the Nutritional Risk Screening (NRS) tool.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Adequate organ function within 7 days prior to the first dose of study drug (no blood products, hematopoietic growth factors, leukocyte- or platelet-stimulating agents allowed in the 7 days prior to laboratory testing):
• Absolute neutrophil count ≥ 1.5 × 10⁹/L Platelets ≥ 100 × 10⁹/L Hemoglobin ≥ 90 g/L Serum albumin ≥ 30 g/L AST and ALT ≤ 2.5 × upper limit of normal (ULN); if liver metastases are present, AST and ALT ≤ 5 × ULN Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN allowed for subjects with Gilbert syndrome) Serum creatinine ≤ 1.5 × ULN; if \> 1.5 × ULN, creatinine clearance (CLcr) calculated by Cockcroft-Gault formula must be ≥ 50 mL/min Left ventricular ejection fraction (LVEF) \> 50% Proteinuria \< 2+ (if ≥ 2+, 24-hour urine protein quantification must be \< 1 g) International normalized ratio (INR) ≤ 1.5 × ULN or prothrombin time (PT) prolongation ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
• No plans for pregnancy during the study period.

You may not qualify if:

• 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.
• 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.
• Any serious concomitant disease, as judged by the investigator, that may endanger the subject's safety or interfere with the subject's ability to complete the study.
• Receiving long-term systemic corticosteroid therapy (daily dose \>10 mg prednisone equivalent) within 7 days prior to the first dose of the combination therapy.
• Any of the following cardiovascular diseases:
• Acute myocardial infarction within 6 months prior to the first dose of the combination therapy.
• History of and/or current New York Heart Association (NYHA) Class III or IV heart failure.
• Poorly controlled cardiovascular disease, including angina, pulmonary hypertension, or severe cardiac rhythm or conduction abnormalities.
• Mean QT interval corrected by Fridericia's formula (QTcF) \>450 ms (male) or \>470 ms (female) on 12-lead electrocardiogram (ECG) prior to the first dose of the combination therapy.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

toripalimab; Axitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nengwang Yu

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YiPing Wang

CONTACT

+8613963647619; wypsduedu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Urology

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)