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
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGR0 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.
Time frame: 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.
Time frame: through study completion, an average of 3 year
Preoperative Treatment Safety: Treatment-Related Side Effects
Treatment-Related Side Effects
Time frame: Through treatment completion (before surgery), an average of 4 cycles (each cycle is 21 days)
Perioperative Complications
Intraoperative Blood Loss, Karnofsky Score, and Hospital Stay
Time frame: Throughout treatment until 30 days after surgery
Progression free survival
Progression free survival was assessed by imaging (enhanced CT, enhanced MRI or both ) after surgery every 12 weeks until 12 months.
Time frame: Every 12 weeks until 12 months after surgery
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.
Time frame: Within 14 days after surgical resection
Patient-Reported Quality of Life
EORTC QLQ-C30 and FKSI-15 Scores
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)
Overall Survival (OS)
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.
Time frame: Follow-up is performed once every 3 months (±14 days)
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