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
• 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