Renal cancer
Conditions
Interventions
Treatment group:Axitinib plus toripalimab
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years old; 2. Clear cell renal cell carcinoma with at least one measurable bone metastasis; 3. Primary tumor resection (partial or radical nephrectomy) must be performed >=3 weeks before enrollment; 4. Have not received immunotherapy and targeted therapy for renal tumors; 5. ECOG score 0-1; 6. Normal hematopoiesis and organ function 1) Hematopoietic function (no blood transfusion or blood products, no hematopoietic stimulating factor or other drugs to correct blood cells within 2 weeks before the first dose of the trial drug) : absolute neutrophil count (ANC) > 1.5×10^9/L; Platelet count >=100×10^9/L; Hemoglobin >=9.0g/dL; 2) Renal function: serum creatinine 30 ml /min; 3) Liver function: total bilirubin 1.5×ULN but normal direct bilirubin; AST and ALT<=2.5×ULN; 7. Able to sign informed consent; 8. The subjects and their spouses were willing to use highly effective contraceptive methods and not to donate sperm during the whole study period and 3 months after the last dose; 9. Understand and plan visits, treatments, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Non-clear cell renal cell carcinoma; 2. Prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy; 3. Prior treatment with systemic VEGF, VEGFR, or mTOR inhibitor drugs, including but not limited to sunitinib, axitinib, sorafenib, pazopanib, cabozantinib, lenvatinib, bevacizumab, and everolimus; 4. Have participated or are currently participating in an investigational drug trial within 4 weeks before the first dose of trial medication, unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study 5. Lack of resolution of toxicity from previous antineoplastic therapy, i.e., not resolved to baseline, NCI-CTCAE 5.0 grade 0-1 (except alopecia), or inclusion/exclusion criteria. Irreversible toxicities (e.g., hearing loss) that would not reasonably be expected to be exacerbated by the study drug could be enrolled; 6. Other malignant tumors that progressed or required treatment within 5 years before enrollment (excluding well-treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cancer in situ of the breast, cervix, or prostate); 7. Presence of a history of central nervous system (CNS) metastases or CNS metastases on imaging (MRI or CT) at baseline within 30 days before the first dose of trial administration; 8. Hypertension that is poorly controlled (systolic blood pressure >=150mmHg and/or diastolic blood pressure >=100mmHg) with one drug; 9. The following cardiovascular events occurred within 6 months before enrollment: 1) Myocardial infarction 2) unstable angina pectoris 3) cardiac angioplasty or stenting 4) coronary/peripheral artery bypass grafting (CABG) 5) New York Heart Association class III or IV congestive heart failure 6) cerebrovascular accident or transient ischemic attack 10. QT interval corrected for heart rate (QTc) >=500 msec (Bazett's formula); 11. History of active or other major bleeding within 30 days before enrollment and hemoptysis within 6 weeks before randomization; 12. Deep vein thrombosis or pulmonary embolism within 6 months before enrollment; 13. Clinically significant gastrointestinal (GI) abnormalities, including: 1) malabsorption, total gastrectomy, or any condition that may affect oral drug absorption; 2) active ulcers treated within the previous 6 months; 3) active gastrointestinal bleeding (e.g., hematemesis, hematochezia, or melena) within the previous 3 months without evidence of recovery on endoscopy or colonoscopy; 4) gastrointestinal metastases suspected of bleeding, inflammatory bowel disease, ulcerative colitis, gastrointestinal perforation, or other gastrointestinal diseases that increase the risk of perforation; 14. History of organ transplantation or long-term corticosteroid therapy. Patients with thyroid, adrenal or hypopituitarism that could be controlled with hormone replacement therapy alone, type 1 diabetes mellitus, psoriasis or vitiligo without systemic treatment, etc., were eligible to participate in the study. 15. Previous or current (noninfectious) pneumonia/interstitial lung disease requiring corticosteroid therapy; 16. Presence of active infection requiring systemic therapy, presence of human immunodeficiency virus (HIV) infection (known HIV antibody positive), presence of active HBV or HCV infection (HBsAg positive, or HBcAb positive but HBsAg negative, with additional DNA quantification; If the results did not exceed the upper limit of normal value of the research laboratory, they c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression-free survival rate (bone metastatic lesion); | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-years overall survival rate; | — |
Countries
China
Contacts
Public ContactHongqian Guo
Nanjing Drum Tower Hospital
Outcome results
None listed