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

September 13, 2025 updated by: Tianjin Medical University Second Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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, The main objective of the study was to evaluate whether the treatment was beneficial to patients undergoing surgery.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300211
        • Recruiting
        • Tianjin Medical University Second Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Embolization plus 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 in the preoperative and patients need to continue taking the drug for a year after surgery
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.
Other Names:
  • Super-selective tumor arterial embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 Resection Rate
Time Frame: through study completion, an average of 3 year
The proportion of patients who achieve complete resection with no residual tumor cells detected at the surgical margin, serving as a primary outcome measure to assess the success of surgical intervention in the study.
through study completion, an average of 3 year
ORR
Time Frame: through study completion, an average of 3 year
According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, the objective response rate (ORR) following preoperative treatment was assessed by the investigator.
through study completion, an average of 3 year
Preoperative Treatment Safety: Treatment-Related Side Effects
Time Frame: Through treatment completion (before surgery), an average of 4 cycles (each cycle is 21 days)
Treatment-Related Side Effects
Through treatment completion (before surgery), an average of 4 cycles (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Complications
Time Frame: Throughout treatment until 30 days after surgery
Intraoperative Blood Loss, Karnofsky Score, and Hospital Stay
Throughout treatment until 30 days after surgery
Progression free survival
Time Frame: Every 12 weeks until 12 months after surgery
Progression free survival was assessed by imaging (enhanced CT, enhanced MRI or both ) after surgery every 12 weeks until 12 months.
Every 12 weeks until 12 months after surgery
Major Pathological Response
Time Frame: Within 14 days after surgical resection
Defined as ≤10% residual viable tumor cells in the resected tumor specimen (assessed by pathological examination after surgery). Serves as a secondary outcome to evaluate the effectiveness of preoperative therapy in reducing tumor burden at the pathological level.
Within 14 days after surgical resection
Patient-Reported Quality of Life
Time Frame: Through adjuvant treatment completion (after surgery), with assessments once every 3 weeks for a total of 17 cycles (each cycle is 21 days)
EORTC QLQ-C30 and FKSI-15 Scores
Through adjuvant treatment completion (after surgery), with assessments once every 3 weeks for a total of 17 cycles (each cycle is 21 days)
Overall Survival (OS)
Time Frame: Follow-up is performed once every 3 months (±14 days)
Subjects will undergo survival follow-up until the earliest occurrence of the following events: subject death, loss to follow-up, withdrawal of informed consent, completion of 5 years of survival follow-up, or study termination.
Follow-up is performed once every 3 months (±14 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of responser with predictive biomarker positive
Time Frame: Through treatment completion (before surgery), an average of 4 cycles (each cycle is 21 days)
Bulk RNA-seq and/or single cell RNA-seq were performed in part of tissues before and after neoadjuvant treatment to seek biomarkers predicting Response
Through treatment completion (before surgery), an average of 4 cycles (each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Second Hospital

Investigators

  • Principal Investigator: Changyi Quan, MD, Tianjin Medical University Second Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

September 8, 2025

First Posted (Estimated)

September 15, 2025

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 13, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SETAR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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