Renal Cancer
Conditions
Interventions
control group (Targeted therapy with immunotherapy):None
treatment group (Targeted therapy with immunotherapy combined with radiotherapy):None
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed renal carcinoma (patients diagnosed outside the hospital must provide original pathological slides); diagnosed with recurrent or metastatic renal carcinoma by PET/CT or other imaging examinations; 2. The number of lesions is no more than 5, eligible for comprehensive radiation therapy; or, if more than 5, at least 2 lesions can be treated with radiation therapy as assessed by the Department of Radiation Oncology and the Department of Radiology. 3. Willing to participate in the study voluntarily and sign informed consent; 4. Male or female, aged =18 years (inclusive) and <80 years; 5. Expected survival period =12 weeks; 6. Subjects have measurable lesions as defined by RECIST 1.1 criteria; 7. ECOG performance status score of 0 or 1; 8. Adequate cardiac, bone marrow, liver, and kidney function: - (1) Left ventricular ejection fraction =50%; - (2) Hemoglobin =9g/dL; - (3) Absolute neutrophil count (ANC) =1.5×109/L; - (4) Platelets =100×109/L; - (5) Serum total bilirubin =1.5 times the upper limit of normal (ULN); - (6) ALT and AST =2.5 times ULN without liver metastasis, and ALT and AST =5 times ULN with liver metastasis; - (7) Serum creatinine =1.5×ULN; 9. For female subjects: should be surgically sterilized, postmenopausal, or agree to use at least one medically approved contraceptive measure (such as intrauterine device [IUD], contraceptive pills, or condoms) during the study treatment period and for 6 months after the end of the study treatment period; serum or urine pregnancy test must be negative within 7 days before enrollment, and must be non-lactating. Male subjects should agree to use at least one medically approved contraceptive measure (such as condoms, abstinence, etc.) during the study treatment period and for 6 months after the end of the study treatment period; 10. Willing and able to comply with the trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Extensive or multiple metastases; 2. Known allergy to the investigational drug or its components; 3. Participation in other clinical studies or toxicity from previous treatments not recovered to grade 0-1 (except for grade 2 alopecia); 4. Underwent major surgery within 4 weeks prior to the start of study treatment and not fully recovered; 5. Received live vaccines within 4 weeks prior to the start of study treatment or planned to receive any vaccines during the study period; 6. Other severe, uncontrollable concomitant diseases that may affect protocol compliance or interfere with result interpretation, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes, uncontrolled hypertension, cardiovascular diseases (NYHA class III or IV heart failure, II° atrioventricular block or higher, myocardial infarction within the past 12 months, unstable arrhythmia or unstable angina, stroke within 6 months, etc.), or pulmonary diseases (interstitial pneumonia, obstructive pulmonary disease and symptomatic history of bronchospasm), or occurrence of deep vein thrombosis or pulmonary embolism within 6 months; 7. History of other malignant tumors within 5 years prior to study treatment initiation, except: - Localized low-risk prostate cancer (defined as stage =T2b, Gleason score =7, and PSA =20ng/mL at the time of prostate cancer diagnosis (if measured), patients who have received curative treatment and have no prostate-specific antigen (PSA) recurrence can participate in this study); - Malignant tumors that can be expected to be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery); 8. CNS metastases and/or carcinomatous meningitis. 9. Active autoimmune diseases requiring systemic treatment within the past 2 years (e.g., with disease-modifying drugs, corticosteroids, or immunosuppressive drugs); 10. History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 11. Significant pleural effusion or ascites requiring symptomatic treatment; 12. Pregnant or lactating women; 13. Positive HIV test result; 14. Patients with active hepatitis B or hepatitis C infection: - Patients positive for HBsAg or HBcAb and positive for HBV DNA copy number (quantitative detection limit of 500IU/ml) must undergo HBV DNA testing during study screening; - Patients with positive HCV antibody test results can be included in this study only when the HCV RNA PCR test result is negative. 15. History of active tuberculosis; 16. Any other diseases, metabolic abnormalities, physical examination abnormalities, or laboratory abnormalities that, in the investigator's judgment, raise concerns about the patient's suitability for the investigational drug or would affect the interpretation of study results or place the patient at high risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival 2, PFS2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival 1, PFS1;Overall survival, OS;Distant progression-free survival,DPFS;Objective response rate,ORR;Disease control rate,DCR;Side effect; | — |
Countries
China
Contacts
Public ContactXianshu Gao
Peking University First Hospital
Outcome results
None listed