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

NCT07172386 | Recruiting Phase 2 DMC

• 1 other identifier: SETAR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Cell Carcinoma (RCC)

Keywords

Toripalimab; Axitinib; Super-selective renal artery embolization; Advanced Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• R0 Resection Rate

  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

  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

  Treatment-Related Side Effects

  Through treatment completion (before surgery), an average of 4 cycles (each cycle is 21 days)

Secondary Outcomes (5)

• Perioperative Complications

  Throughout treatment until 30 days after surgery

• Progression free survival

  Every 12 weeks until 12 months after surgery

• Major Pathological Response

  Within 14 days after surgical resection

• Patient-Reported Quality of Life

  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)

  Follow-up is performed once every 3 months (±14 days)

Other Outcomes (1)

• Rate of responser with predictive biomarker positive

  Through treatment completion (before surgery), an average of 4 cycles (each cycle is 21 days)

Study Arms (1)

Embolization plus toripalimab and axitinib

EXPERIMENTAL

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

Interventions

Toripalimab and axitinib DRUG

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.

Also known as: Super-selective tumor arterial embolization

Embolization plus toripalimab and axitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

Related Publications (19)

• ournal/Source：Presented at: American Society of Clinical Oncology - Genitourinary Cancers Symposium (ASCO - GU) 2025 • Publication Year：2025 • Other Info：Abstract #477684

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MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

toripalimab; Axitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Changyi Quan, MD

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shimiao Zhu, MD,PhD

CONTACT

+86 88328607; zhushimiao@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

CN (1)