Clear cell renal carcinoma
Conditions
Interventions
Sponsors
Xi'an Jiaotong University Second Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically confirmed clear cell renal carcinoma (pT3-T4, N0, M0; pTany, N +, MO) at high risk of recurrence after radical nephrectomy for renal cancer. 2. ECOG (Performance status, PS) score 0-1; 3. hematological tests consistent with: i. Neutrophils = 1.5 * 109/L; ii. Platelets = 100 * 109/L; iii. Hemoglobin > 9.0 g/dL; iv. Serum creatinine = 1.25 ULN or creatinine clearance (CrCl) = 50 mL/min; v. AST/ALT = 2.5 ULN; vi. Total bilirubin = 1.5 ULN; vii. INR/APTT within the normal range; 4. patients older than 18 years, less than 80 years; 5. no prior systemic therapy. 6. must be confirmed by the investigator to be tumor-free by imaging assessment before enrollment 7. must have had radical nephrectomy within 12 weeks prior to enrollment 8. female subjects of childbearing potential should have a urine or serum pregnancy test performed within 72 hours prior to receiving the first dose of study drug and demonstrate negative, and are willing to use an effective method of contraception during the trial until 3 months after the last dose of terlizumab.
Exclusion criteria
Exclusion criteria: 1. patients with or suspected autoimmune diseases. Note: Patients with Hashimoto 's thyroiditis who presented with vitiligo, type I diabetes, or hypothyroidism but only required hormone replacement therapy could be included in the study if there were no obvious signs of recurrence; 2. Patients require systemic cortisol therapy (> 10 mg prednisolone [or equivalent]/day) or other immunosuppressive drugs within 14 days of enrollment. Note: Inhaled or topical corticosteroids, or adrenal hormone replacement therapy (> 10 mg prednisolone [or equivalent]/day) may be administered to patients without significant autoimmune disease; 3.3-4 grade interstitial lung disease; 4. patients with other malignant tumors and require anti-tumor therapy; 5. Patients with previous other malignant tumors (except skin malignant tumors other than non-melanoma, and carcinoma in situ at the following sites [bladder, stomach, colorectal, endometrium, cervix, melanoma or breast]) cannot be included in this study. However, if the malignancy has achieved complete remission for two years or more, and no additional anti-tumor therapy is required during this study; 6. the investigator believes that the patient is medically, psychologically, or physically unable to complete this study or cannot understand the patient brochure information; 7. previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA, and other drugs against T cell costimulation or immune regulatory pathways; 8. presence of active hepatitis B or C; 9. Positive HIV test or confirmed acquired immunodeficiency disease (AIDS); 10. allergic to the study drug; 11. pregnant or lactating women. 12. patients who are participating in other clinical studies 13. Researchers believe that individuals who are not suitable for clinical research due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2y-DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;DFS;OS; | — |
Countries
China
Contacts
Public ContactFu Delai
Xi'an Jiaotong University Second Affiliated Hospital
Outcome results
None listed