Renal Cell Carcinoma
Conditions
Interventions
Subject group:Carrilizumab combined with Apatinib neoadjuvant therapy
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male and female; 2. The patient was diagnosed as renal cell carcinoma complicated with inferior vena cava cancer thrombus by imaging examination and puncture pathology; 3. Never received systemic treatment for renal cell carcinoma, including surgery, chemotherapy, radiotherapy, immunization and targeted therapy; 4. Patients suitable for and planning to receive neoadjuvant therapy; 5. Patients with medium-low risk MSKCC and IMDC scores 6. ECOG score; 0-1 score; 7. Estimated survival time >=6 months; 8. The investigator confirmed at least one measurable lesion according to RECIST1.1 criteria; 9. Major organ functions are normal, and test results during screening must meet the following requirements: 1) The standard of blood routine examination shall be met (no blood transfusion or blood products within 14 days, no correction by G-CSF and other hematopoietic stimulating factors) : A. Hemoglobin (Hb) >= 90g/L, and no suspended red blood cells were transfused during screening; B. neutrophil number (ANC) >= 1.5 × 109/L; C. Platelet count (PLT) >= 100 ×109/L; 2) Biochemical examination shall meet the following standards: A. Total bilirubin (TBIL) 60ml/min (Cockcroft-Gault formula); D. Routine urine test results showed urine protein (UPRO) < 2+ or 24 h urinary protein quantification < 1g; 10. Women of childbearing age must have been using reliable contraception or have had a pregnancy test (serum or urine) with negative results within 7 days prior to inclusion and be willing to use an appropriate method of contraception during the trial period and 60 days after the last test drug administration. For males, consent is required to use an appropriate method of contraception or surgical sterilization during the trial period and 120 days after the last administration of the test drug; 11. Signed a written informed consent and expected to comply well with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Previous receipt of anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-ctLA-4 antibodies (or any other antibody acting on the T-cell co-stimulation or checkpoint pathway); 2. Previous exposure to other anti-angiogenic small molecule TKI drugs, such as pazopanib, Sorafenib, Regofenib, Cildenib, etc., or anti-angiogenic mab drugs such as bevacizumab; 3. Patients with liver metastasis and brain metastasis; 4. Use of immunosuppressive drugs within 28 days prior to initial use of carrilizumab, excluding nasal and inhaled corticosteroids or systemic steroid hormones at physiological doses (i.e., not exceeding 10 mg/ day of prednisolone or other corticosteroids at an equivalent physiologic dose); 5. Systematic systemic therapy with Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) with anti-tumor indications within 28 days prior to initial administration; 6. Administer live attenuated vaccine within 30 days of initial administration or expected during the study period; 7. Pleural effusion, pericardial effusion or ascites with clinical symptoms requiring drainage, or who had received serosal effusion drainage for therapeutic purposes within 4 weeks before randomization; 8. Patients with serious cardiovascular diseases: Grade ? or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval >= 450 ms for men and 470 ms for women); Patients with grade ? to ? cardiac insufficiency (according to the New York Heart Society NYHA rating, see Annex 8), or left ventricular ejection fraction (LVEF) < 50% indicated by color ultrasound; 9. Severe infection (e.g., antibiotic, antifungal, or antiviral intravenous infusion) occurring within 4 weeks prior to initial administration, or unexplained fever occurring during screening/prior to initial administration; 38.5°C; Or receive major surgical treatment within 3 weeks prior to initial medication; 10. Active autoimmune disease or immunodeficiency, or a history of the above, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituitaritis, vasculitis, nephritis, etc.) shall not be included. Exceptions include: Patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy. Patients with type 1 diabetes whose blood sugar is under control after treatment with an insulin administration regimen may participate in this study. 11. The subjects were treated with bronchodilators and other systemic treatments, but their asthma control was not satisfactory and they could not be included (those with complete remission of asthma in childhood could be included without any intervention after adulthood). 12. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis B, hepatitis C (HCV antibody positive and HCV-RNA above the lower detection limit of analytical methods) or co-infection with hepatitis B and hepatitis C; Note: Hepatitis B subjects who met the following criteria were also eligible for inclusion: HBV viral load prior to initial dosing must be < At 1000 copies /ml (200 IU/ml), subjects should receive anti-HBV therapy to avoid viral reactivation throughout the study chemotherapy regimen. Subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-) do not require prophylactic a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with reduced mayo grade of tumor thrombus; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR;Disease Control Rate,DCR;Pathological complete response, pCR;Major Pathological Response,MPR;Event-free survival,EFS;Height of tumor thrombus;maximum diameter of tumor thrombus;Overall Survival,OS; | — |
Countries
China
Contacts
Public ContactShudong Zhang
Peking University Third Hospital
Outcome results
None listed