Clear cell renal cell carcinoma(ccRCC)
Conditions
Interventions
Treatment group:Vorolanib + Toripalimab
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily participates in this study and signs the informed consent form. 2. Age: 18 - 80 years old (at the time of signing the informed consent form). 3. Pathologically or histologically confirmed unresectable or metastatic clear - cell renal cell carcinoma. 4. No prior systemic drug therapy for the advanced - stage disease. 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0 - 1; estimated survival time exceeding 3 months. 6. Representative formalin - fixed, paraffin - embedded tumor specimens or fresh - frozen tissue specimens that can confirm the diagnosis of clear - cell renal cell carcinoma, accompanied by relevant pathological reports. The specimens can be collected through surgical resection or biopsy of the primary tumor, or biopsy or resection of metastatic lesions. 7. Confirmed to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1). 8. Good major organ function and adequate hematological function, meeting the following criteria: Absolute neutrophil count (ANC) >= 1.5×10^9/L without the use of granulocyte colony - stimulating factor in the recent 14 days. Platelet count >= 90×10^9/L without platelet transfusion or the use of thrombopoietin in the recent 14 days. Hemoglobin > 9 g/dL without blood transfusion or the use of erythropoietin in the recent 14 days. 9. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) = 2.8 g/dL. 12. Creatinine = 30 mL/min. 13. Urine protein/creatinine ratio (UPCR)<=1 mg/mg (<=113.2 mg/mmol). 14. For women who are not post - menopausal (amenorrhea for less than 12 months) or surgically sterile (no ovaries and/or uterus): agree to use two appropriate contraceptive methods, including at least one method with an annual failure rate of <= 1%. 15.For female subjects of childbearing potential, a urine or serum pregnancy test should be performed within 3 days before the first dose of the study drug (Cycle 1, Day 1) and the result should be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non - childbearing - potential women are defined as those who have been post - menopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy. 16. If there is a risk of pregnancy, all subjects (regardless of gender) should use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period and until 120 days after the last dose of the study drug (or 180 days after the last dose of the chemotherapy drug). 17.Be able to understand and comply with the protocol requirements and must sign the informed consent document.
Exclusion criteria
Exclusion criteria: 1. History of prior systemic therapy for advanced - stage disease or concomitant other tumors; 2. Receipt of any type of small - molecule kinase inhibitor within 2 weeks before the start of treatment; 3. Receipt of any type of anticancer antibody, cytotoxic anticancer therapy, or any other investigational drug within 4 weeks before the start of treatment; 4. Known malignant tumors of the brain or spinal cord or meningeal diseases; 5.Patients who require analgesics must be on a stable treatment regimen at the start of the study; 6. Subjects with active central nervous system (CNS) metastases can participate in the study if their CNS metastases can be adequately treated and their neurological symptoms can return to the baseline level at least 2 weeks before enrollment (excluding residual signs or symptoms related to CNS treatment). In addition, subjects must be either not using corticosteroids or receiving prednisone (or equivalent) at a stable or tapering dose of <=10 mg/day; 7. Currently participating in an interventional clinical study treatment or having received other investigational drugs or used investigational device treatments within 4 weeks before the first dose; 8. History of active autoimmune disease requiring systemic treatment (e.g., glucocorticoids or immunosuppressants) within 2 years before the first dose. Substitute therapies (e.g., thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment; 9. Receiving systemic glucocorticoid therapy (excluding nasal, inhaled, or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: The use of physiologic doses of glucocorticoids (<=10 mg/day of prednisone or equivalent) is allowed; 10. Known allergy to the active ingredients or excipients of the study drugs; 11.Pregnant or lactating women; 12.Not having fully recovered (i.e., <=Grade 1 or returned to baseline, excluding fatigue or alopecia) from the toxicity and/or complications caused by any previous interventions before the start of treatment; 13. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies); 14. Untreated active hepatitis B (defined as positive HBsAg and detectable HBV - DNA copy number greater than the upper limit of normal of the local laboratory); Note: Hepatitis B subjects meeting the following criteria can also be enrolled: ? HBV viral load <1000 copies/mL (200 IU/mL) before the first dose. Subjects should receive anti - HBV treatment throughout the study treatment period to prevent viral reactivation; ? For subjects who are anti - HBc (+), HBsAg (-), anti - HBs (-), and HBV viral load (-), preventive anti - HBV treatment is not required, but close monitoring for viral reactivation is needed; 15. Subjects with active HCV infection (positive HCV antibody and HCV - RNA level above the lower limit of detection); 16.Vaccination with live vaccines within 30 days before the first dose (Cycle 1, Day 1); Note: Injection of inactivated seasonal influenza virus vaccine within 30 days before the first dose is allowed; however, intranasal attenuated live influenza vaccine is not allowed. 17. Presence of any severe or uncontrolled systemic diseases, such as: Significant and severely symptomatic and difficult - to - control abnormalities in rhythm, conduction, or morphology on resting electrocardiogram, such as complete left - bun
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Overall Survival;overall survival (OS) rates;Safety; | — |
Countries
China
Contacts
Public ContactGuodong Zhu
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed