Metastatic Renal Cell Carcinoma
Conditions
Interventions
Drug treatment group:Camrelizumab + Apatinib
Drugs combined with surgical treatment group:Camrelizumab + Apatinib+Cytoreductive Surgery
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18-65, male or female; 2. Histopathologically proven metastatic renal clear cell carcinoma or sarcomatoid renal cell carcinoma (stage IV); 3. The determination of resectability ultimately depends on the clinical judgment of urologists and oncologists involved in patient care; 4. No previous systematic treatment, including surgery, chemotherapy, radiotherapy and targeted therapy; 5. The performance status of the Eastern Cooperative Oncology Group (ECOG) was 0 or 1; 6. Measurable lesions conforming to RECIST 1.1 criteria (long diameter >= 10mm in spiral CT scan or short diameter >= 15mm in enlarged lymph node according to RECIST 1.1) are available, and measurable lesions suitable for surgery; 7. Expected survival >= 12 months; 8. No emergency intervention was found; 9. The patient had no brain metastasis and no other tumors with high risk of metastasis; 10. No medical complications that could not accept systematic treatment; 11. Adequate hematological and terminal organ function within 4 weeks prior to the first study treatment was defined as follows: 1) Neutrophilic granulocyte count (ANC) >= 1500/mm3 (no granulocyte colony-stimulating factor support during the 2 weeks prior to cycle 1, day 1); 2) White blood cell count (WBC) > 2500/µL; 3) Lymphocyte count >= 500/µL; 4) Platelet count (PLT) >= 100,000/mm3 (no blood transfusion within 2 weeks before cycle 1, day 1); 5) Hemoglobin (Hb) >= 9 g/dL (patients can be treated with blood transfusion or erythropoiesis to meet this standard); 6) Serum creatinine (Cr) = 60mL/min (Cockcroft-Gault formula); 7) Total bilirubin (Bil) <= 1.5 times the upper limit of normal value (ULN); 8) AST/SGOT or ALT/SGPT levels <= 2.5 times the upper limit of normal value (ULN) (patients with known Gilbert disease whose serum bilirubin level <= 3 x ULN can participate); 9) Internationally standardized ratio (INR) <= 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) <= 1.5x ULN (this is only applicable to patients not receiving therapeutic anticoagulant therapy;Patients receiving therapeutic anticoagulant therapy should receive a steady dose); 12. Women should agree to use contraceptives (such as intrauterine devices [IUDs], contraceptives or condoms) during the study period and for 6 months after the end of the study;Negative serum or urine pregnancy test within 7 days prior to study enrolment and must be non-lactating;Men should agree to use contraception during the study period and within 6 months after the end of the study period; 13. Subjects are willing, understanding and able to sign the informed consent and abide by the agreement.
Exclusion criteria
Exclusion criteria: 1. Patient has any active or history of autoimmune diseases (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism;The patient had vitiligo;Complete remission of asthma in childhood can be included in adults without any intervention;Asthma patients requiring bronchodilators for medical intervention were not included); 2. Patients who are taking immunosuppressive drugs or systemic hormonal therapy ( > 10mg/ day or other therapeutic hormone) for immunosuppressive purposes and are continuing to take the drug within 2 weeks prior to the first administration; 3. Severe allergic reactions to other monoclonal antibodies; 4. The subjects had untreated transfer of central nervous system, always received systemic, radical brain or meningeal metastasis treatment (radiation therapy or surgery), such as stable imaging has to maintain at least a month, and have stopped systemic sex hormone therapy (> 10 mg/day dose effect of hormones such as prednisone or other) greater than 2 weeks, no clinical syndrome of patients can be incorporated into; 5. Have hypertension that is not well controlled by antihypertensive medication (systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg); 6. Have clinical cardiac symptoms or diseases that are not well controlled, such as: 1) NYHA2 or above heart failure; 2) unstable angina pectoris; 3) Had myocardial infarction within 1 year; 4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 5) QTC > 450ms (male); QTC > 470ms(female); 6) Cardiac ejection fraction EF 2.0, PT BBB > S), with bleeding tendency or receiving thrombolytic or anticoagulant therapy, allowing prophylactic use of low-dose aspirin and low-molecular weight heparin; 8. Any bleeding event with a severe grade of 2 or more on CTCAE 5.0 within 4 weeks prior to the first administration; 9. Imaging shows that the tumor has invaded vital blood vessels or the patient's tumor is highly likely to invade vital blood vessels and cause fatal massive bleeding during treatment, as determined by the investigator; 10. Artery/venous thrombosis events occurred within 6 months before the first administration, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 11. Patients with radioactive enteritis after pelvic radiotherapy within 12 months prior to medication were studied; 12. Active infection, unexplained fever >= 38.5 degrees C, 7 days before medication, or white blood cell count > 15 x 10^9/L at baseline; 13. A known history or evidence of interstitial lung disease or non-infectious pneumonia treated with corticosteroids; Or patients who may interfere with the detection or management of suspected drug-related pulmonary toxicity; 14. Have a history of immunodeficiency, including positive human immunodeficiency virus (HIV) sera or other acquired or congenital immunodeficiency disease, and the subject is known to be active in tuberculosis; 15. Active stage of known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV reference: HBsAg positive and HBV DNA >= 500IU/ mL;Hepatitis C reference: HCV antibody positive and HCV virus copy number > upper limit of normal value); 16. Patients had other malignancies within the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine;urine routine;blood biochemistry;fecal occult blood test;Coagulation Func;Thyroid Function; | — |
Countries
China
Contacts
Public ContactHE Zhisong
Peking University First Hospital
Outcome results
None listed