Clear cell renal carcinoma
Conditions
Interventions
Queue 1:Vorolanib + Toripalimab
Queue 2:Treatment regimens approved for first-line indication of metastatic clear cell renal cell carcinoma are all available
Sponsors
Xi'an Jiaotong University Second Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in this study and sign an 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 of the disease; 5. ECOG PS score: 0-1; estimated survival period exceeds 3 months; 6. Representative formalin-fixed, paraffin-embedded tumor specimens or fresh frozen tissue specimens that can clearly diagnose clear cell renal cell carcinoma, accompanied by relevant pathology reports. 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 RECIST V1.1 criteria; 8. Main organ functions are good and hematological parameters are sufficient, meeting the following criteria: (1) Absolute neutrophil count (ANC) >=1.5x10^9/L without the use of granulocyte colony-stimulating factors in the past 14 days; (2) Platelets >=90×10^9/L without platelet transfusion or thrombopoietin use in the past 14 days; (3) Hemoglobin >9g/dL without blood transfusion or erythropoietin use in the past 14 days; 9. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) =2.8 g/dL; 12. Creatinine =30mL/min; 13. Urine protein/creatinine ratio (UPCR) <=1mg/mg (<=113.2 mg/mmol); 14. For non-menopausal (amenorrhea for 12 months) or surgically sterilized (without ovaries and/or uterus) women: agree to use two appropriate contraceptive methods, including at least one with an annual failure rate <=1%; 15. For female subjects of childbearing age, a urine or serum pregnancy test should be performed within 3 days before the first study drug administration (Day 1 of Cycle 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 women are defined as those who have been menopausal for at least one year, or who have undergone surgical sterilization or hysterectomy; 16. If there is a risk of conception, all subjects (male or female) must use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration); 17. Ability to understand and comply with the protocol requirements, must sign the informed consent document.
Exclusion criteria
Exclusion criteria: 1. Prior receipt of systemic therapy for the advanced stage of the disease or concurrent 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 brain or spinal cord tumors or meningeal diseases; 5. Patients requiring analgesics must be on a stable treatment regimen at the start of the study; 6. Subjects with active central nervous system (CNS) metastases may participate in the study if their CNS metastases can be adequately treated, and their neurological symptoms have recovered to baseline levels at least 2 weeks before enrollment (excluding residual signs or symptoms related to CNS treatment). In addition, subjects must not be taking corticosteroids or must be receiving a stable or gradually decreasing dose of <=10mg/day of prednisone (or equivalent); 7. Currently participating in interventional clinical studies or having received other investigational drugs or used investigational devices within 4 weeks before the first dose; 8. History of active autoimmune disease requiring systemic treatment (such as corticosteroids or immunosuppressive agents) within 2 years before the first dose of the study. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment; 9. Receiving systemic corticosteroid therapy (excluding nasal, inhaled, or other local routes of corticosteroids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: The use of physiological doses of corticosteroids (<=10 mg/day of prednisone or equivalent) is allowed; 10. Known allergy to the active ingredient or excipients of the investigational drug; 11. Pregnant or breastfeeding women; 12. Not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., <= grade 1 or baseline, excluding fatigue or alopecia); 13. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 14. Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA copy number above the upper limit of normal at the local laboratory); Note: Hepatitis B subjects who meet the following criteria may also be enrolled: (1) HBV viral load <1000 copies/mL (200 IU/mL) before the first dose, and the subject should receive anti-HBV treatment throughout the study to prevent viral reactivation; (2) For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV treatment is not required, but close monitoring for viral reactivation is necessary; 15. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the detection limit); 16. Vaccinated with a live vaccine within 30 days before the first dose (Note: Inactivated virus vaccines for seasonal influenza administered by injection are allowed within 30 days before the first dose; however, intranasal live attenuated influenza vaccines are not allowed); 17. Presence of any severe or uncontrolled systemic disease, such as: (1) Resting electrocardiogram showing significant and severely symptomatic and uncontrolled abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, second-degree or hi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;disease control rate, DCR;Overall survival, OS;12-month & 24-month OS rates;safety; | — |
Countries
China
Contacts
Public ContactFu Delai
Xi'an Jiaotong University Second Affiliated Hospital
Outcome results
None listed