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
cT2N0M0 with Grade 4 or sarcomatoid feature;
cT3-4N0M0;
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);
Single group
Toripalimab and axitinib
DrugPatients 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.
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.
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.
Preoperative Treatment Safety: Treatment-Related Side Effects
Treatment-Related Side Effects
Perioperative Complications
Intraoperative Blood Loss, Karnofsky Score, and Hospital Stay
Progression free survival
Progression free survival was assessed by imaging (enhanced CT, enhanced MRI or both ) after surgery every 12 weeks until 12 months.
Major Pathological Response
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.
Patient-Reported Quality of Life
EORTC QLQ-C30 and FKSI-15 Scores
Rate of responser with predictive biomarker positive
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
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