PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk

An Open-label, Investigator-initiated, Single Arm, Exploratory Phase 2 Trial Evaluating the Feasibility and Efficiency of PET/CT Directed Free of Therapy Used for Metastatic and Advanced Renal Cell Carcinoma

PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk (NCT07175480) is a Phase 2 interventional studying Renal Cell Carcinoma (RCC) and Metastatic Renal Cell Carcinoma (mRCC), sponsored by Jinling Hospital, China. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This phase 2 trial aims to test the feasibility and efficiency of PET/CT-directed treatment interruption strategy in metastatic renal cell carcinoma patients with IMDC favorable/intermediate risk who achieve complete (CMR) or partial metabolic response (PMR) after ≥12 months of first-line PD-1/PD-L1 Immune checkpoint inhibitor (ICI)+ VEGFR-tyrosine kinase inhibitor (TKI) therapy. It helps figure out whether PET/CT can safely direct treatment pause as well as explores a new individualized treatment option based on metabolic imaging for RCC patients.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Renal Cell Carcinoma (RCC) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Pre-screening Who May Qualify: 1. Male or female subjects aged ≥ 18 years at time of signing willing to sign a consent form 2. Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer \[AJCC\] Stage IV) 3. Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria 4. Eastern Cooperative Oncology Group performance status 0 or 1 5. Karnofsky Performance Status (KPS) grade ≥ 70% 6. Adequate organ and bone marrow function meeting all laboratory criteria: Ⅰ. Absolute neutrophil count (ANC) ≥ 1.5 × 10³/μL (≥ 1.5 GI/L); Platelet count ≥ 100 × 10³/μL (≥ 100 GI/L); blood count (hemoglobin) at least 9 g/dL (≥ 90 g/L) Ⅱ. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 × upper limit of normal. Total bilirubin ≤ 1.5 × the upper limit of normal (≤ 3 mg/dL \[≤ 51.3 μmol/L\] if Gilbert's syndrome) Ⅲ. Serum creatinine ≤ 2.0 × upper limit of normal or calculated kidney function (creatinine clearance) at least 30 mL/min using the Cockroft-Gault formula. 7. Capacity to comprehend and comply with protocol requirements, with documented willing to sign a consent form signed 8. Contraception agreement for sexually active fertile participants and partners to use of medically accepted methods during study and continue for 5 months after last treatment 9. Negative pregnancy status at screening for women of childbearing potential Pre-screening Who Should NOT Join This Trial: 1. Highly malignant pathology 2. previous cancer treatment that works throughout the body (like chemotherapy) for advanced RCC 3. Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria 4. ECOG performance status \>1 5. Karnofsky Performance Status (KPS) \<70% 6. Inadequate organ and bone marrow function 7. Bulky or symptomatic disease or hepatic metastases ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Pre-screening Inclusion Criteria: 1. Male or female subjects aged ≥ 18 years at time of signing informed consent 2. Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer \[AJCC\] Stage IV) 3. Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria 4. Eastern Cooperative Oncology Group performance status 0 or 1 5. Karnofsky Performance Status (KPS) grade ≥ 70% 6. Adequate organ and bone marrow function meeting all laboratory criteria: Ⅰ. Absolute neutrophil count (ANC) ≥ 1.5 × 10³/μL (≥ 1.5 GI/L); Platelet count ≥ 100 × 10³/μL (≥ 100 GI/L); Hemoglobin ≥ 9 g/dL (≥ 90 g/L) Ⅱ. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 × upper limit of normal. Total bilirubin ≤ 1.5 × the upper limit of normal (≤ 3 mg/dL \[≤ 51.3 μmol/L\] if Gilbert's syndrome) Ⅲ. Serum creatinine ≤ 2.0 × upper limit of normal or calculated creatinine clearance ≥ 30 mL/min using the Cockroft-Gault formula. 7. Capacity to comprehend and comply with protocol requirements, with documented informed consent signed 8. Contraception agreement for sexually active fertile participants and partners to use of medically accepted methods during study and continue for 5 months after last treatment 9. Negative pregnancy status at screening for women of childbearing potential Pre-screening Exclusion Criteria: 1. Highly malignant pathology 2. Prior systemic therapy for advanced RCC 3. Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria 4. ECOG performance status \>1 5. Karnofsky Performance Status (KPS) \<70% 6. Inadequate organ and bone marrow function 7. Bulky or symptomatic disease or hepatic metastases 8. Active brain metastases or leptomeningeal disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before the start of treatment. 9. Concurrent or prior invasive malignancies that could confound efficacy assessment, except adequately treated non-melanoma skin cancer, superficial bladder cancer or carcinoma in situ of the cervix/breast with curative therapy \>3 years ago. 10. Uncontrolled hypertension (\>150/100 mmHg despite optimal therapy) 11. Uncontrolled comorbidities within 6 months including but not limited to: clinically significant cardiovascular disorders, gastrointestinal disorders with high risk of perforation or fistula formation, significant hematuria, hematemesis, hemoptysis, or major bleeding history, severe infections, severe autoimmune diseases (e.g., systemic lupus erythematosus, immune pneumonitis), active HIV, HBV, or HCV infections. 12. Major surgery within 4 weeks with unhealed wounds or planned surgery during study 13. Concomitant use of drugs or substances affecting activity or pharmacokinetics of investigational products 14. Hypersensitivity to any component of study drugs 15. Chronic or concurrent immunosuppressive therapy, except Inhaled/topical steroids 16. Medical/psychiatric/social conditions compromising protocol compliance 17. Pregnancy, lactation, or refusal of contraception during and for 5 months post-treatment 18. Inability to undergo PET/CT or oral drug administration Main-screening Inclusion Criteria: 1. Patient must receive≥12 months of first line treatment with the combination of PD-1/PD-L1 ICI and VEGFR-TKI, and have not experienced a toxicity that prevents them from continuing on therapy. 2. Patients must achieve complete metabolic response (CMR) or partial metabolic response (PMR) on PET/CT within 24 months of the combination treatment with PD-1/PD-L1 ICI and VEGFR-TKI. 3. Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria 4. Eastern Cooperative Oncology Group performance status 0 or 1 5. Karnofsky Performance Status (KPS) grade ≥ 70% 6. Adequate organ and bone marrow function meeting all laboratory criteria: Ⅰ. Absolute neutrophil count (ANC) ≥ 1.5 × 10³/μL (≥ 1.5 GI/L); Platelet count ≥ 100 × 10³/μL (≥ 100 GI/L); Hemoglobin ≥ 9 g/dL (≥ 90 g/L) Ⅱ. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 × upper limit of normal. Total bilirubin ≤ 1.5 × the upper limit of normal (≤ 3 mg/dL \[≤ 51.3 μmol/L\] if Gilbert's syndrome) Ⅲ. Serum creatinine ≤ 2.0 × upper limit of normal or calculated creatinine clearance ≥ 30 mL/min using the Cockroft-Gault formula. 7. Capacity to comprehend and comply with protocol requirements, with documented informed consent signed 8. Contraception agreement for sexually active fertile participants and partners to use of medically accepted methods during study and continue for 5 months after last treatment 9. Negative pregnancy status at screening for women of childbearing potential Main-screening Exclusion Criteria: 1. Failure to complete ≥12 months of first-line PD-1/PD-L1 + VEGFR-TKI therapy due to unmanageable toxicity or other reasons 2. Failure to achieve CMR or PMR on PET/CT within 24 months after combination therapy; new metastatic lesions or disease progression on PET/CT. 3. Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria 4. ECOG performance status \>1 5. Karnofsky Performance Status (KPS) \<70% 6. Inadequate organ and bone marrow function 7. Uncontrolled hypertension (\>150/100 mmHg despite optimal therapy) 8. Uncontrolled comorbidities including but not limited to: clinically significant cardiovascular disorders, gastrointestinal disorders with high risk of perforation or fistula formation, significant hematuria, hematemesis, hemoptysis, or major bleeding history, severe infections, severe autoimmune diseases (e.g., systemic lupus erythematosus, immune pneumonitis), active HIV, HBV, or HCV infections. 9. Medical/psychiatric/social conditions compromising protocol compliance 10. Pregnancy, lactation, or refusal of contraception during study period. 11. Inability to undergo PET/CT or oral drug administration Withdrawal Criteria: 1. Disease progression with unsatisfactory efficacy, or occurrence of intercurrent illnesses during treatment or follow-up period. 2. Occurrence of severe treatment-related adverse reactions. 3. Laboratory test results indicating critical safety values. 4. Voluntary withdrawal of informed consent by the patient. 5. Investigator's judgment that withdrawal is in the subject's best interest. 6. Pregnancy during the trial period. 7. Wrong Enrollees: deviation of inclusion or exclusion criteria. 8. Poor patient compliance. 9. Loss to follow-up or death during the trial period.

Treatments Being Tested

DRUG

Intermittent PD-1/PD-L1 ICI + VEGFR-TKI

Any PD-1/PD-L1 inhibitor or VEGFR-TKI that is commercially marketed, regulatory-approved and reimbursed under public health plans.Dose as recommended by the manufacturer.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China

Nanjing, Jiangsu, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07175480), the sponsor (Jinling Hospital, China), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07175480 clinical trial studying?

Who can participate in NCT07175480?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07175480?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07175480. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07175480. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.