Renal cell carcinoma
Conditions
Interventions
Positive group:Postoperative adjuvant therapy with penpulimab in renal clear cell carcinoma, treatment requires up to 17 cycles (approximately 1 year), with each cycle lasting 21 days. On day 1 of eac
Negative group:Postoperative follow-up
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1. 2.Has received no prior systemic therapy or checkpoint inhibitors with adjuvant or neoadjuvant for advanced RC3) 3.Has undergone a partial nephroprotective or radical complete nephrectomy with negative surgical margins. 4.Has histologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell while meeting the following conditions: 5.The population at very-high risk after renal cancer surgery was comprehensively assessed according to the Renal Cancer Prognostic Grading System (UISS) and WHO/ISUP grading prognostic model established by the University of California, Los Angeles 5.1pT3a/G1-2, N0, M0 (>= 2 risk factors of pT3a); pT3a/G3-4, N0, M0; pT3b-pT4/G any grade, N0, M0; any T stage/G any grade, N +, M0; 5.2 M1 RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, = 90 g/L; 2) neutrophil count (ANC) >= 1.5 × 10^9/L; 3) platelet count (PLT) >= 80 × 10^9/L; (2) Biochemical examination: 1) total bilirubin = 60 mL/min; (3) Good cardiac function: 1) score (LVEF) >=50%; 2) QT interval <= 480 ms; 9.Non-lactating patients with negative serum or urine pregnancy test within 7 days before study entry; women of childbearing age must agree to use highly effective methods of contraception during the study and within 6 months after administration of study drugs; 10.Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance.
Exclusion criteria
Exclusion criteria: 1. Known allergic reactions to the active ingredients and or any excipients of pembrolizumab (grade >= 3); 2. Previous systemic therapy or immune checkpoint inhibitors; 3. Patients 12 before enrollment to undergo major surgery except nephrectomy and/or distant metastases of metastatic renal cancer. 4. Previous history of radiotherapy for renal cancer; 5. Has been diagnosed with metastatic renal cancer or has brain metastases or bone metastases; 6. The presence of venous thromboembolism (VTE) in the renal vein or vein after nephrectomy; 7. Received anti-tumor monoclonal antibodies or other study drug treatment before enrollment; previously received other anti-PD-1 antibody therapy or other PD-1/PD-L1 therapy; 8. Patients are using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive purposes (dose greater than 10 mg/day prednisone or other equivalent hormones), and are still using 7 times before enrollment; 9. Patients have any active autoimmune disease or a history of autoimmune disease, the past two years need systemic treatment (such as: corticosteroids or immunosuppressive drugs); 10. Known progression of other malignancies or need for active treatment within less than 3 years. 11. History of (non-infectious) or current pneumonia on steroid therapy; 12. Previous history of dialysis or ongoing dialysis; 13. Patients with congenital or acquired immune dysfunction; 14. Hyperactive/venous thrombotic events occurred within 6 months before enrollment, such as cardiovascular-cerebrovascular (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by previous chemotherapy that has been judged by the investigator to have recovered) and pulmonary embolism; 15. Urine routine showed urinary protein 2 + or more or 24-hour urinary protein > 150 mg/L; 16. Patients with suspected other primary cancers; 17. Concomitant diseases/medical history: (1) Arteriovenous thrombotic events occurred within 6 months before randomization, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by previous chemotherapy) and pulmonary embolism; (2) Hypertension, not well controlled by antihypertensive drug treatment (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg); 6 months before randomization, the following conditions: myocardial infarction, severe/unstable angina, NYHA grade 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias and symptomatic congestive heart failure; (3) Interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases (such as diabetes, pulmonary fibrosis and acute pneumonia, etc.); (4) Renal insufficiency: urine protein >=+ +, Or confirmed 24-hour urine protein >= 1.0g;) History of attenuated live vaccination 30 days before the first dose of study drug or expected to receive attenuated live vaccination during the study period; (5) Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); (6) Active hepatitis (hepatitis B, defined as HBV-DNA >= 500 IU/ml; hepatitis C, defined as HCV-RNA above the lower limit of detection of the analytical method) or combined hepatitis B and C co-infection; (7) Severe infection 4 days before the first dose,Including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; 2. Active infection with CTCAE >=
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival, DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS; | — |
Countries
China
Contacts
Public ContactZhang Xu
Chinese PLA General Hospital
Outcome results
None listed