Efficacy and Safety of Voronib Combined With Everolimus After Immunotherapy Failure in Advanced Renal Carcinoma
This single-arm exploratory study included patients with renal clear cell carcinoma who had previously received one type of immunotherapy and failed. The specific regimen was Voronib 200mg PO.QD combined with everolimus 5mg QD. 80 patients were planned to continue treatment until PD, toxicity became intolerable, patient withdrawal was informed, or medication had to be discontinued. Collect patient medication information and disease efficacy evaluation, adverse reactions. In this study, blood samples were collected 0-4 weeks before treatment, 2 months, 4 months, 6 months, 8 months of drug treatment, and at the time of PD progression for ctDNA detection.
• Clear cell carcinoma of the kidney is confirmed by pathology (histology or cytology);
• Have received systemic anti-tumor therapy with no more than 2 targeted drugs (excluding mTOR inhibitors) and 1 immune checkpoint inhibitor and failed treatment;
• Not less than 3 weeks after receiving the last systemic anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy, biotherapy or endocrine therapy), Or not less than 5 half-lives since the last systemic antitumor treatment; And treatment-related toxicity was recovered to meet the laboratory test requirements for this study;
• ECOG score ≤ 1;
• Over 18 years old, and less than or equal to 75 years old; a life expectancy of more than 12 weeks
• According to RECIST 1.1 criteria: at least one measurable lesion;
• Organ function levels must meet the following requirements:
• Bone marrow: blood test results must show hemoglobin ≥ 80 g/L, platelets ≥ 90 x 10\^9/L, absolute neutrophil count ≥ 1.5 x 10\^9/L; Liver: serum bilirubin ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (if there is liver metastasis, AST and ALT ≤ 5 times the upper limit of normal are allowed); Serum creatinine \< 1.5 times the upper limit of normal; Urinary protein ≤ 2+, if urinary protein \> 2+, a 24-hour urine protein test must be collected with a total amount ≤ 2 grams; Well-controlled hypertensive patients; Echocardiogram shows left ventricular ejection fraction greater than 40%;
• For women of childbearing potential, the serum pregnancy test must be negative within 7 days prior to randomization;
• All enrolled subjects (regardless of gender) must use effective barrier contraceptive methods throughout the treatment period and for 4 weeks after treatment ends;
⁃ Subjects must have the ability to understand and voluntarily sign the informed consent form, and the signing of the informed consent must occur prior to any study procedure.