metastatic renal cell carcinoma
Conditions
Interventions
single arm:Axitinib, Tripletiumab and SBRT
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject is diagnosed with metastatic renal cell carcinoma and was treated with standard first-line treatment (cytokine/targeted drugs). The subject has any progressive lesion <= 6cm and the progressive lesion <= 3, which meets RECIST 1.1 or MDA criteria for bone metastases and not start the second-line treatment. 2. The subject has been progress of standard first-line treatment (cytokine/targeted drugs) for metastatic renal cell carcinoma, with the diameter of the progressive lesion <= 6cm and the lesion <= 3. Second-line Axitinb has been initiated treatment no more than two weeks and the efficacy has not been evaluated. 3. The subject is more than or equal to 18 years old; 4. The subject has 0-2 points according to ECOG; 5. The life expectancy is more than or equal to 3 months; 6. Functions of major organs: No significant abnormalities are found in liver, kidney, bone marrow, heart and other important organs; 7. No significant abnormalities are found on ECG, or the abnormalities show no clinical significance; 8. Women of childbearing age must confirm non-pregnancy prior to enrollment. All enrolled subjects (male and female) must take adequate barrier methods for birth control during the entire treatment period and within 4 weeks after the end of treatment; 9. The subject must be capable of understanding and voluntarily signing the informed consent. The informed consent must be signed prior to any tests.
Exclusion criteria
Exclusion criteria: The physicians determine that the patient cannot safely receive the clinical treatment due to any other severe diseases or clinical conditions, including but not limited to the following items: 1. Contraindications for radiotherapy; 2. Previous use of Axitinb in the treatment of metastatic renal cell carcinoma; 3. Previous use of immunotherapy (pd-1 / pd-l1) for metastatic renal cell carcinoma; 4. Previously received first-line or above systematic treatment for metastatic renal cancer: targeted drug/immune/cytokine therapy, and the efficacy evaluation has been conducted; 5. The progressive lesions had received radiotherapy or were not suitable for SBRT treatment; 6. The subject with progressive lesion > 6cm and/or the lesion > 3. 7. The subject is receiving first-line treatment, and the disease progression criteria are not met according to the assessment criteria of recist-1.1 and MDA for bone metastasis; 8. ECOG score > 2; 9. Severe heart and cerebral vascular diseases, uncontrollable hypertension and diabetes, and incomplete renal function or renal failure; 10. HIV positive, or other immune deficiencies; patient who need to take large doses of hormones for a long time; 11. Clear history of metal illness, affecting his/her understanding of informed consent and compliance with study; 12. Other malignant tumors which have not been cured; 13. Women in pregnancy or lactation; 14. Any condition that is not stable or may jeopardize the safety of the subject and his/her compliance with the study; or other factors that the investigators believe that the subject is not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;DCR;1 year local control rate;life quality score; | — |
Countries
China
Contacts
Public ContactDong Pei
Sun Yat-Sen University Cancer Center
Outcome results
None listed