New combo therapy aims to shrink kidney tumors before surgery
NCT ID NCT07172386
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This phase 2 trial tests a three-part approach for advanced kidney cancer: first, a procedure to block blood flow to the tumor, then two drugs (toripalimab and axitinib) before surgery, followed by more toripalimab after surgery. The goal is to see if this makes surgery more successful and controls the cancer longer. The study involves 40 participants and is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- toripalimab and axitinib
- What this could lead to
- If successful, this combination could improve surgical outcomes and control advanced kidney cancer more effectively, potentially extending survival.
- What could go wrong
- This is a small, early-phase trial with only 40 participants. The treatment may cause side effects, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Medical University Second Hospital
RECRUITINGTianjin, Tianjin Municipality, 300211, China
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Other studies related to the condition(s) this trial covers.
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