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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Preoperative Therapy of Super-selective Tumor Artery Embolization Combined With Toripalimab and Axitinib in Advanced RCC

A Study on the Safety and Efficacy of Super-selective Tumour Arterial Embolisation in Combination With Toripalimab and Axitinib as a Preoperative Treatment for Advanced Renal Cell Carcinoma

Preoperative Therapy of Super-selective Tumor Artery Embolization Combined With Toripalimab and Axitinib in Advanced RCC (NCT07172386) is a Phase 2 interventional studying Renal Cell Carcinoma (RCC), sponsored by Tianjin Medical University Second Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a phase II study to determine the efficacy and safety of Super-selective tumor artery embolization combined with toripalimab and axitinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment plan is beneficial to the patient's operation. Patients will undergo super-selective embolization of the feeding arteries to the renal tumour one week prior to drug therapy, followed by toripalimab administered every three weeks for three to four consecutive cycles combined with axitinib administered for four consecutive cycles in the preoperative and patients need to continue taking the drug for a year after surgery

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 40 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)

Who May Qualify: - Willing and able to provide written willing to sign a consent form - Age ≥ 18 years - Patients with pathologically and radiographically confirmed renal cell carcinoma: - cT2N0M0 with Grade 4 or sarcomatoid feature; - cT3-4N0M0; - cTanyN1M0; - M1 that can be returned to M0 through local therapy - Preoperative imaging evaluation can be performed radical excision or tumor reduction surgery - There are no suspected brain metastases - The presence of measurable lesions was assessed according to RECISTv1.1 criteria - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 - Organ function level must meet the following requirements: Hematological indexes: neutrophil count \>= 1.5x10\^9/L, platelet count \>= 100x10\^9/L, hemoglobin \>= 9.0 g/dl (can be maintained by blood transfusion); Liver function: total bilirubin \<=1.5 ULN, alanine aminotransferase and aspartate aminotransferase \<=1.5 ULN - Non-surgically sterilized or reproductive-age female patients must use a medically approved contraceptive method (such as an intrauterine device, oral contraceptives, or condoms) during the study treatment period and for 3 months after its completion; Female patients who are not surgically sterilized or are of childbearing potential must have a negative serum or urine HCG test within 7 days prior to study enrollment and must not be lactating. Male patients who are not surgically sterilized or are of childbearing potential must agree to use one medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the study treatment period ends. - The subjects volunteered to join the study, signed willing to sign a consent form, and had good compliance with follow-up Who Should NOT Join This Trial: - Prior receipt of radiotherapy, chemotherapy, long-term or high-dose corticosteroid therapy, surgery, or molecular targeted therapy ...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
Inclusion Criteria: * Willing and able to provide written informed consent * Age ≥ 18 years * Patients with pathologically and radiographically confirmed renal cell carcinoma: * cT2N0M0 with Grade 4 or sarcomatoid feature; * cT3-4N0M0; * cTanyN1M0; * M1 that can be returned to M0 through local therapy * Preoperative imaging evaluation can be performed radical excision or tumor reduction surgery * There are no suspected brain metastases * The presence of measurable lesions was assessed according to RECISTv1.1 criteria * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * Organ function level must meet the following requirements: Hematological indexes: neutrophil count \>= 1.5x10\^9/L, platelet count \>= 100x10\^9/L, hemoglobin \>= 9.0 g/dl (can be maintained by blood transfusion); Liver function: total bilirubin \<=1.5 ULN, alanine aminotransferase and aspartate aminotransferase \<=1.5 ULN * Non-surgically sterilized or reproductive-age female patients must use a medically approved contraceptive method (such as an intrauterine device, oral contraceptives, or condoms) during the study treatment period and for 3 months after its completion; Female patients who are not surgically sterilized or are of childbearing potential must have a negative serum or urine HCG test within 7 days prior to study enrollment and must not be lactating. Male patients who are not surgically sterilized or are of childbearing potential must agree to use one medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the study treatment period ends. * The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up Exclusion Criteria: * Prior receipt of radiotherapy, chemotherapy, long-term or high-dose corticosteroid therapy, surgery, or molecular targeted therapy * Subjects with a history of or concurrent other malignancies (except those controllable and not affecting 2-year survival) * Prior treatment with other PD-1/PD-L1 therapies; Known history of allergy to macromolecular protein preparations or any known PD-1 component * Active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or childhood asthma that has achieved complete remission without requiring any intervention in adulthood may be included; subjects requiring medical intervention with bronchodilators for asthma are excluded); * Subjects currently using immunosuppressive agents for immunosuppression purposes and continuing such use within 2 weeks prior to enrollment * Uncontrolled cardiac clinical symptoms or diseases, such as: * New York Heart Association (NYHA) Class II or higher heart failure; * Unstable angina; * Myocardial infarction within the past year; * Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention * Coagulation abnormalities (PT \> 16s, APTT \> 43s, TT \> 21s, Fbg \> 2g/L) with bleeding tendency or currently receiving thrombolytic or anticoagulant therapy; * Active gastrointestinal bleeding within 3 months prior to first dose due to esophageal varices, active gastric or duodenal ulcer, ulcerative colitis, portal hypertension, or unresected tumors; or other conditions judged by the investigator to potentially cause gastrointestinal bleeding or perforation * History or current presence of major bleeding (≥30 mL within 3 months), hemoptysis (≥5 mL fresh blood within 4 weeks), or thromboembolic events (including stroke and/or transient ischemic attack) within 12 months * Active infection or unexplained fever \>38.5°C occurring during screening or prior to first dose * History of abdominal fistula, gastrointestinal perforation, or abdominal abscess within 4 weeks prior to first dose * Objective evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe pulmonary impairment * Subjects with congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (transaminase levels not meeting inclusion criteria; for hepatitis B: HBV DNA ≥10⁴/ml; for hepatitis C: HCV RNA ≥10³/ml); chronic hepatitis B virus carriers with HBV DNA ≥2000 IU/ml (≥10⁴ copies/ml) must concurrently receive antiviral therapy during the study to be eligible for enrollment * Subjects currently participating in other clinical studies or those who completed a prior clinical study within the past month; subjects may receive other systemic antitumor therapies during the study period * Administration of live vaccines within 4 weeks prior to study drug initiation or during the study period * Known history of psychiatric drug abuse, alcoholism, or substance abuse; * Inability or refusal to bear out-of-pocket costs for examinations and treatments * The investigator deems the subject should be excluded from this study, such as when the investigator determines the subject has other factors that may necessitate premature termination of the study, including: other serious illnesses (including psychiatric disorders) requiring concomitant treatment, severe laboratory abnormalities, or family/social factors that may compromise subject safety or interfere with data/sample collection.

Treatments Being Tested

DRUG

Toripalimab and axitinib

Patients will undergo super-selective embolization of the feeding arteries to the renal tumour one week prior to drug therapy, followed by toripalimab administered every three weeks for four consecutive cycles combined with axitinib administered for four consecutive cycles before surgery, and followed by 17 cycles' toripalimab for adjuvant therapy.

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.

Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07172386), the sponsor (Tianjin Medical University Second Hospital), 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 NCT07172386 clinical trial studying?

This is a phase II study to determine the efficacy and safety of Super-selective tumor artery embolization combined with toripalimab and axitinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment plan is beneficial to the patient's operation. Patients will undergo super-selective embolization of the feeding arteries to the renal tumour one week prior to drug therapy, followed by toripalimab administered every three weeks for three to four consecutive cycles combined with axitinib administered for four consecutive cycles in the preoperative and p… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07172386?

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 NCT07172386?

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 NCT07172386. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07172386. 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.