Renal Cell Carcinoma
Conditions
Interventions
Intervention group:camrelizumab, apatinib and SBRT
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Aged >18 years; (2) ECOG 0-1; (3) Life expectancy >12 weeks; (4) Histologically confirmed non-clear cell renal cell carcinoma, radiographically or pathologically diagnosed recurrence or distant metastasis; (5) At least one target lesion according to RECIST 1.1; (6) Lesions receiving SBRT accounts for over 50% of the total tumour burden, and tumour burden was calculated according to RECIST 1.1; (7) No major dysfunction in main organs 7 days before treatment: a. HGB >= 80 g/L, ANC >= 1.5*10^9 /L, PLT= 100*10^9 /L; b. TBIL<= 1.5 * ULN, ALT, AST and/or AKP <= 2.5 * ULN; c. Cr <= 1.5 ULN; d. APTT and INR <= 1.5* ULN; e.TSH <= ULN (abnormal TSH with normal T3 and T4 is also acceptable); 8. Women with child-bearing potential are using effective contraception are not pregnant or lactating and agree not to become pregnant during trial treatment and 6 months thereafter. A negative pregnancy test before inclusion into the trial is required for all women with child-bearing potential 7 days before admission. Men agree to use contraception during and 6 months after the trial.^
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating women. (2) Allergy to any component of camrelizumab or patinib mesylate. (3) Brain or liver metastasis. (4) Prior irradiation of sites that will be target for cytoreductive SBRT. (5) Contraindications to radiotherapy. (6) A history of other malignany within 5 years, except for adequately treated skin basal cell carcinoma, cervical carcinoma in situ, and papillary thyroid cancer. (7) Uncontrolled disorder of major organs, such as myocardial infarction, heart failure, pulmonary embolism, decompensated cirrhosis. (8) History of: a) anti PD-1, anti PD-L1 or anti CTLA-4 antibodies. b) investigational drugs within 4 weeks. c) enrolled in another clinical trial at the same time. d) corticosteroids ( >= 10mg prednisone or equivalent dose a day) within 2 weeks, or other systemic immunosuppressive agents, but corticosteroids for local use, allergy prevention, atiemesis and edema is acceptable. e) anti-tumor vaccines, or administration of a live or attenuated vaccine within 4 weeks of first dose of study drug. f) major surgery or sever trauma within 4 weeks; (9) Sever infection (at least CTCAE grade 2) within 4 weeks, such as sever pneumonia, bacteraemia and infection-related complications that require hospitalisation; active pneumonia at baseline; infection that requires antibiotics (prophylactic antibiotics are allowed). (10) Active tuberculosis at baseline or within one year. (11) Active or history of autoimmune disease (including but not limited to interstitial lung disease, colitis, hepatitis, hypophysitis, vasculitis and nephritis); leukoderma and controlled asthma or allergy are allowed. (12) Congenital or aquired immunodeficiency. (13) History of organ transplantation or bone marrow transplantation. (14) Active viral hepatitis, including Hepatitis B (HBV DNA >= 2000IU/ml or10000 copies/ml), Hepatitis C (positive HCV antibody with HCV-RNA above normal). (15) Psychoactive substance, alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival;toxicity;disease control rate;duration of response;quality of life; | — |
Countries
China
Contacts
Public ContactLiru He
Sun Yat-Sen University Cancer Center
Outcome results
None listed