Advanced sarcomatoid renal cell carcinoma
Conditions
Interventions
Experimental group:camrelizumab plus Pazopanib Tablets
Control group:Pazopanib Tablets
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 80 years; 2. Estimated survival period >= 3 months; 3. According to the eighth edition of TNM stage M1 renal tumor, tumor reduction nephrectomy or puncture biopsy were performed, postoperative pathology confirmed msrcc; 4. At least one measurable lesion other than the brain was confirmed according to RECIST 1.1 standard; 5. ECOG score: 0-1 points; 6. Has not received any systematic anti-tumor treatment for advanced diseases; 7. No brain metastasis, or accompanied by asymptomatic brain metastasis, or symptomatic brain metastasis and stable after treatment; 8. Hematological function: absolute count of neutrophil >= 1.5 x 10^9 / L, platelet count >= 100 x 10^9 / L, hemoglobin >= 90 g / L; 9. Adequate liver function: the total bilirubin level is less than 1.5 times the normal upper limit, the level of aspartate aminotransferase and alanine aminotransferase level is less than 2.5 times the normal upper limit; 10. Adequate renal function: defined as creatinine clearance rate >= 50ml / min (Cockcroft Gault formula); 11. Sufficient coagulation function: international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times the upper normal limit; if the participants is receiving anticoagulant therapy, INR / Pt will be in the range anticoagulant drugs define; 12. Female participants should use high-efficiency contraception until 180 days at least after stopping the trial treatment. It was confirmed that the urine pregnancy test or serum pregnancy test was negative in women of childbearing age within 3 days before the first study drug administration. 13. Subjects voluntarily join the study and sign an informed consent form, with good compliance and matching close follow-up.
Exclusion criteria
Exclusion criteria: 1. Histologically, there were Bellini collecting duct carcinoma, renal medullary carcinoma and undifferentiated renal cell carcinoma with sarcomatoid differentiation. 2. Patients with meningioma or meningeal metastasis or unstable brain metastasis; 3. Patients who have had any arterial thrombosis, embolism or ischemic or hemorrhagic diseases in the past 6 months and have no improvement or instability after corresponding treatment, such as unstable myocardial infarction, unstable angina pectoris, cerebrovascular accident, etc.; 4. Hemoptysis occurred in recent 3 months. The amount of bleeding was defined as bright red blood greater than or equal to 2.5ml. 5. Other malignant tumors were diagnosed in recent 5 years, excluding skin basal cell carcinoma, skin squamous cell carcinoma and / or carcinoma in situ after radical resection; 6. The patients who had received chemotherapy or EGFR TKIs in the past, received adjuvant or neoadjuvant therapy, and the time from the last treatment to the recurrence was less than 6 months; 7. Those who have been proved to be allergic or contraindicated to carrizumab or pezopanib or their excipients; 8. The baseline pregnancy test was positive in pregnant and lactating women or fertile women; 9. Female patients of childbearing age or male patients with family planning who are unwilling to take effective contraceptive measures during the whole trial period and within 6 months after the end of the trial; 10. There is interference in clinical trials, hindering the subjects' participation in the whole process, or the researchers think it is not in the best interests of the subjects; 11. Patients with hypertension of grade 2 or above before treatment and without improvement or instability after antihypertensive drug treatment; patients with hypertensive crisis or hypertensive encephalopathy; 12. Patients with nephrotic syndrome or proteinuria >= 2 + or above before treatment, without improvement or instability after treatment; 13. Patients with other diseases need surgery within 60 days; 14. There was a history of gastrointestinal perforation in recent 6 months; 15. Previous history of severe brain disease, especially in patients with grade III / IV white matter lesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective response rate;Disease Control Rate;Duration of Response;Safety; | — |
Countries
China
Contacts
Public ContactYu Nengwang
Qilu Hospital of Shandong University
Outcome results
None listed