clear cell renal cell carcinoma
Conditions
Interventions
Experiment Group:camrelizumab+apatinib mesylate
Sponsors
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed renal clear cell carcinoma; 2. Locally advanced/metastatic (newly diagnosed stage IV renal clear cell carcinoma as assessed by AJCC) or recurrent clear cell renal carcinoma; 3. Patients with advanced or metastatic clear cell renal cell carcinoma who have not received systemic therapy (including but not limited to TKIs, VEGF and mTOR); 4. According to RECIST1.1, with clinically evaluable lesions; 5. Age >= 18 years old, male or female (calculated on the day of signing the informed consent); 6. Expected survival >= 12 months; 7. The patient's ECOG score is 0-1; 8. The main organ functions are normal, and there is no serious abnormal blood, heart, lung, liver, kidney function and immune deficiency diseases. Specific test index requirements: (1) Absolute neutrophil count >=1.5x10^9/L; (2) Platelets>=100x10^9/L; (3) Hemoglobin>=100 g/L; (4) Serum albumin>=30 g/L; (5) Bilirubin= 45 mL/min; (8) Blood urea nitrogen (BUN) <= 2.5xULN; (9) Thyroid-stimulating hormone (TSH)<=ULN, if abnormal, T3 and T4 levels should be investigated, and normal T3 and T4 levels can be selected. 9. Able and willing to comply with research and follow-up procedures; 10. Men and women of gestational age must agree to take adequate contraceptive measures throughout the study period and within 6 months after the end of treatment; 11. Be able to understand and be willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Exclude patients with advanced or metastatic clear cell renal cell carcinoma who have received systemic therapy in the past (including but not limited to TKIs, VEGF, and mTOR, including multiple targeted therapies); patients who have received adjuvant or neoadjuvant therapy Patients with clear cell renal cell carcinoma with no recurrence and metastasis for more than one year can be included. 2. There is central nervous system metastasis (including brain metastasis, meningeal metastasis, etc.); 3. Previous use of any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody or any other antibody or drug that specifically targets T-cell costimulation or checkpoints for the treatment pathway ; 4. Subjects who have undergone major surgery (such as nephrectomy) or chemotherapy within 4 weeks before the first dose; 5. Those who are allergic to the test drug; 6. For hypertensive patients with active bleeding, ulcers, intestinal perforation, intestinal obstruction, and uncontrollable medication; (definition of controllable hypertensive patients: blood pressure = 2000 IU/ml or copy number >= 104/ml; hepatitis C reference: HCV antibody positive , HCV virus copy number > upper limit of normal value); 9. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid function Hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely resolved, without any intervention in adulthood can be included; subjects requiring bronchodilator for medical intervention of asthma can not be included); 10. Symptomatic advanced patients with visceral dissemination who are at short-term risk of life-threatening complications (including uncontrolled massive exudates [thoracic, pericardium, abdominal], pulmonary lymphangitis and 30 % or more patients with liver involvement); 11. Complicated severe infection within 4 weeks before the first dose (such as: need for intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever >38.5°C during the screening period/before the first dose; 12. Patients with a history of other malignancies within five years (except for complete treatment of in situ cervical cancer or basal cell carcinoma or squamous cell carcinoma skin cancer); 13. Received systemic steroid therapy within 14 days before the first study drug treatment or any other form of immunosuppressive therapy; 14. Known history of active tuberculosis (Mycobacterium tuberculosis); 15. The patient is using other therapeutic research or standard anti-tumor drugs; 16. Those who are allergic to the components of the research drug; 17. Active infection; 18. There is a risk of bleeding; 19. Pregnant and lactating patients; 20. The investigator judges other circumstances that may affect the conduct of clinical research and the judgment of research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;1-year survival rate ;safety; | — |
Countries
China
Contacts
Public ContactHuang Jian
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Outcome results
None listed