Carcinoma, Renal CellNCT07500831
Fasting-Mimicking Diet Combined With IO-TKI Combination Therapy in Patients With Metastatic Renal Cell Carcinoma
A study testing Fasting mimicking diet, Toripalimab and Axitinib in people with Carcinoma, Renal Cell and Metastatic Renal Cell Carcinoma, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Metastatic Renal Cell Carcinoma, Advanced Renal Cell Carcinoma
- What is being tested?
- Fasting mimicking diet, Toripalimab and Axitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Known history of substance abuse of psychotropic medications, alcohol abuse, or drug abuse; or history of definite neurological or psychiatric disorders, including epilepsy, dementia, or hepatic encephalopathy.
- Participation in another clinical study and receipt of other investigational therapy within 4 weeks prior to the first dose of the combination therapy.
- Major surgery within 4 weeks prior to the first dose of the combination therapy (adequate wound healing after major surgery must be clinically assessed).
- Arteriovenous thromboembolic events within 6 months prior to the first dose of the combination therapy, including cerebrovascular accident, history of stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other serious thromboembolic events.
- Any patient, as judged by the investigator, who may increase the risk associated with the study, interfere with the interpretation of study results, or is deemed unsuitable for enrollment by the investigator and/or sponsor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Yiping Wang, +8613963647619, wypsduedu@163.com
About this study
Official title: Fasting-Mimicking Diet Combined With Toripalimab Plus Axitinib for Metastatic or Unresectable Renal Cell Carcinoma: A Single-Arm, Open-Label, Single-Center Clinical Trial
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.
Read the 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.
- Being tested
- Fasting mimicking diet, Toripalimab, Axitinib
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting mimicking dietDietary 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).
ToripalimabDrug
Also called Tuoyi
Toripalimab 240 mg IV every 3 weeks (240 mg Q3W) on a 21-day cycle
AxitinibDrug
Also called Inlyta
Axitinib 5 mg orally twice daily (BID).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Fasting mimicking diet; Drug: Toripalimab; Drug: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Progression-free survival assessed according to RECIST version 1.1 and iRECIST criteria.
Measured: 3 years
Objective Response Rate (ORR)
Objective response rate assessed according to RECIST version 1.1 and iRECIST criteria.
Measured: 3 years
Duration of Response (DOR)
Duration of response assessed according to RECIST version 1.1 and iRECIST criteria.
Measured: 3 years
Disease Control Rate (DCR)
Disease control rate assessed according to RECIST version 1.1 and iRECIST criteria.
Measured: 3 years
Overall Survival (OS)
Overall survival, 1-year OS rate, and 2-year OS rate.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunengwang, Qilu Hospital of Shandong University
- Investigators
- Nengwang Yu, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500831
- Sponsor's protocol ID
- KYLL-2025-10-006-1
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fasting-Mimicking Diet Combined With Toripalimab Plus Axitinib for Metastatic or Unresectable Renal Cell Carcinoma: A Single-Arm, Open-Label, Single-Center Clinical Trial
- ClinicalTrials.gov ID
- NCT07500831
- Acronym / sponsor ID
- KYLL-2025-10-006-1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fasting-Mimicking Diet (FMD) Combined with Toripalimab Plus Axitinib | Experimental | Dietary Supplement: Fasting mimicking diet, Drug: Toripalimab, Drug: AxitinibThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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).
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting mimicking dietThe 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). | Dietary supplement | Fasting-Mimicking Diet (FMD) Combined with Toripalimab Plus Axitinib |
| ToripalimabAlso: TuoyiToripalimab 240 mg IV every 3 weeks (240 mg Q3W) on a 21-day cycle | Drug | Fasting-Mimicking Diet (FMD) Combined with Toripalimab Plus Axitinib |
| AxitinibAlso: InlytaAxitinib 5 mg orally twice daily (BID). | Drug | Fasting-Mimicking Diet (FMD) Combined with Toripalimab Plus Axitinib |
Primary outcome
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.
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.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 3 years
Objective Response Rate (ORR)
Time frame: 3 years
Duration of Response (DOR)
Time frame: 3 years
Disease Control Rate (DCR)
Time frame: 3 years
Overall Survival (OS)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nengwang Yu principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting mimicking diet, Toripalimab and Axitinib in people with Carcinoma, Renal Cell and Metastatic Renal Cell Carcinoma, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YiPing Wang (+8613963647619, wypsduedu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.