Renal cancer
Conditions
Interventions
treatment group:None
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients who have histopathologically confirmed kidney cancer (patients not diagnosed at our hospital need to provide an original biopsy); 2. Metastatic renal carcinoma was confirmed by PET/CT; 3. The number of metastatic foci is not more than 5, or the number of metastatic foci is more than 5, but the number of metastatic foci is more than or equal to 3 as assessed by the physicians of the radiology department; 4. A kidney cancer patient who received immunotherapy with a PD-1 inhibitor, standard regimen-targeted therapy, and radiation therapy agreed to: (1) Patients who were accepting tyrosine kinase inhibitors and/or targeted drugs against vascular endothelial growth factor inhibitors as recommended in the guidelines: such as acitinib, or prazopanib, or sunitinib, or sorafenib; (2) Patients who were accepting PD-1 inhibitor immunotherapy terriprizumab injection; (3) Patients who underwent radiation therapy for primary or metastatic sites within 2 months before and after targeted therapy or immunotherapy (a single dose of stereotactic radiation therapy >= 5Gy/f for one lesion); (4) Patients who could voluntarily agree to participate in the study and sign informed consent; 5. Either male or female, aged 18 or older (inclusive) and younger than 80; 6. The expected survival time was >= 12 weeks; 7. Participants had at least one measurable lesion as defined by RECIST 1.1; 8. Lent ECOG scored 0 or 1 for physical fitness; 9. Sufficient heart, bone marrow, liver, and kidney function: (1) Left ventricular ejection fraction >=50%; (2) Hemoglobin >=9g/dL; (3) Absolute neutrophil count (ANC) >=1.5×10*9/L; (4) Platelet >=100 ×10*9/L; (5) Serum total bilirubin <=1.5 times the upper limit of normal (ULN); (6) ALT and AST<=2.5*ULN in the absence of liver metastasis, ALT and AST<=5*ULN in the presence of liver metastasis; (7) Serum creatinine <=1.5*ULN; 10. Female subjects spend time either being surgically sterilized, postmenopausal, or agreeing to use at least one medically approved contraceptive method (such as an intrauterine device [IUD], birth control pills, or condoms) during and for six months after study treatment. Serum or urine pregnancy tests must be negative during the 7 days prior to study enrollment and must be non-lactation. Male subjects should agree to use at least one medically approved contraceptive method (e.g. condom, abstinence, etc.) during the study period and for 6 months after the study period; 11. Patients who are willing and able to comply with trial and follow-up schedules.
Exclusion criteria
Exclusion criteria: 1. Patients who underwent anti-tumor therapy other than targeted therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks prior to study initiation, or whose toxicity from previous therapy had not recovered to level 0-1 (except for 2 degrees of hair loss); 2. Patients underwent major surgery within 4 weeks before the study started and didn't fully recover; 3. Some sort of serious, uncontrollable concomitant illness that can interfere with protocol adherence or interpretation of results, Including active opportunistic infections or progress (serious) infections, diabetes, beyond the control of uncontrolled hypertension, cardiovascular disease (New York heart association class defined III IV or heart failure, II degrees above the heart block, happened in the past 12 months instability of myocardial infarction, arrhythmia or unstable angina, cerebral infarction occurred within six months, etc.) or a history of lung diseases (interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm), deep vein thrombosis or pulmonary embolism within 6 months; 4. Had other malignant tumors in the five years prior to the study, except for: (1) Localized low-risk prostate cancer (defined as stage <=T2b, Gleason score <=7, and PSA<=20ng/mL at prostate cancer diagnosis (if measured) who had undergone radical therapy and had no prostate-specific antigen (PSA) recurrence were eligible to participate); (2) Malignancies that can be expected to heal with treatment (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery); 5. Having suffered from central nervous system (CNS) metastases and/or cancerous meningitis; 6. Either having an active autoimmune disease that requires systematic treatment in the past 2 years (such as using disease-regulating drugs, corticosteroids, or immunosuppressant drugs); 7. Patients have a history of allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 8. Either a large amount of pleural or ascites accompanied by clinical symptoms or requiring symptomatic treatment; 9. Women who are pregnant or breastfeeding; 10. HIV positive; 11. Patients who have active hepatitis B or C: (1) HBsAg or HBcAb positive patients were also detected with positive HBV DNA copy numbers (the limit of quantitative detection was 500IU/ml). These patients must be screened for HBV DNA; (2) Patients with positive HCV antibody test results can only be enrolled in this study if THE PCR test results are negative for HCV RNA. 12. A history of active tuberculosis; 13. Either having any other illness, metabolic abnormality, abnormal physical exam, or abnormal laboratory test, according to the investigator, reasonably suspects that the patient has a disease or condition that makes them unsuitable for the study drug, or that it will affect the interpretation of the study results, or puts the patient at high risk. 14. According to the estimates, patients' compliance to participate in the clinical study was insufficient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity;Objective response rate;Over all survival;Response rate of unirradiated lesions; | — |
Countries
China
Contacts
Public ContactXianshu Gao
Peking University First Hospital
Outcome results
None listed