Renal cancer
Conditions
Interventions
1:Cardonilimab: 10mg/kg, Q3W, 21 days as a cycle, continuous administration until disease progression, intolerable toxicity, drug use for 2 years, patients voluntarily quit, etc.
The drug was administ
2:Cardonilimab: 10mg/kg, Q3W, 21 days as a cycle, continuous administration until disease progression, intolerable toxicity, drug use for 2 years, patients voluntarily quit, etc.
The drug was administ
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before enrollment; 2. Age =18 years old; 3. Histological and/or cytological diagnosis of unresectable advanced renal cell carcinoma; 4. Cohort 1: renal clear cell carcinoma, mainly renal clear cell carcinoma, was included. Patients progressed after previous treatment with immune checkpoint inhibitor (ICI), and the number of previous treatment lines was less than 3; 5. Cohort 2: Non-transparent renal cell carcinoma was included. Subjects who had not received systematic treatment before or whose disease progressed after TKI or ICI treatment before could be included, with the number of previous treatment lines =3; They mainly included cohort A: papillary cell carcinoma, cohort B: chromophobe cell carcinoma, cohort C: collecting tubuloid carcinoma, cohort D: other types. 6. Consent to medical treatment; 7. Understand and voluntarily sign written informed consent. 8.ECOG score: 0 ~ 1; 9. At least one measurable lesion (according to RECIST criteria, the length of CT scan for non-lymph node lesions =10 mm, and the short diameter of CT scan for lymph node lesions =15 mm); 10. Have adequate organ function: 11. Blood routine: Absolute Neutrophil Count (ANC) 1.5×10^9/L, Platelet (PLT) =70×10^9/L, Hemoglobin (HGB) =80g/L; Liver function: Serum Total Bilirubin (TBIL) =1.5× UpperLimit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) =3×ULN; Serum albumin =28 g/L; Alkaline Phosphatase (ALP) =5×ULN; After routine liver protection treatment, the patients could meet the above criteria and be stable for at least 1 week. 13. Kidney function: serum Creatinine (Cr) =1.5×ULN, or creatinine clearance =50 mL/mi (using the standard Cockcroft-Gault formula) : 14. Coagulation function: International Normalized Ratio (INR) =1.5 /PT=1.5×ULN, aPTT=1.5×ULN; If the subject is receiving anticoagulant therapy, as long as PT and INR are within the prescribed range of anticoagulants. 15. Estimated survival =3 months; 16. Use of a medically approved contraceptive method is required during the study treatment period and for at least 120 days after the end of the study, and sperm donation to another person or cryopreservation for fertilization and reproduction is not permitted during this period. 17. Ability to comply with research visit schedules and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Poor patient compliance; 2. Subjects with any severe and/or uncontrolled disease. Includes: Poor blood pressure control (systolic =150mmHg or diastolic =100mmHg); Poor diabetes control (fasting blood glucose [FBG] > 10mmol/L); 3. Have grade =2 myocardial ischemia or myocardial infarction, arrhythmia (QTc=470ms), and grade =2 congestive heart failure (New York Heart Association [NYHA] grade); 4. Active or uncontrolled severe infections (=CTCAE grade 2 infections) requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis. 5. Active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA=2000 IU/ml or =104 copy number /ml; Hepatitis C reference: HCV RNA=2000 IU/ml or =104 copy number /ml; After nucleotide antiviral therapy, those who are lower than the above criteria can be included in the group); Chronic hepatitis B virus carriers, HBV DNA 10mg/ day of prednisone or other equivalent hormone and within 2 weeks of initial administration and continued use; 9. People with a history of active tuberculosis; 10. Failure to control, still need repeated drainage, ascites, pericardial effusion, pleural effusion; 11. Patients who have undergone major organ transplants; 12. Study participants who received major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the start of treatment; Or have a wound or fracture that has not healed for a long time; 13. Patients with severe hypersensitivity after the use of monoclonal antibodies; Known allergy to the active ingredients or excipients of the drug in this study; 14. Participating in or having participated in other clinical investigators within 4 weeks prior to the start of the study; 15. People with a history of severe allergies; 16. At risk of bleeding, or coagulation dysfunction, or being treated with thrombolysis; 17. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 18. Subjects with concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subjects or affect the completion of the study, or subjects with concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subjects or affect the completion of the study, or subjects with concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subjects or affect the completion of the study, or subjects with other reasons that are not suitable for enrollment. Have a clear history of neurological and psychiatric disorders, such as dementia, epilepsy, or predisposition to epilepsy; 19. If, in the investigator's judgment, there is a concomitant medical condi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Validity endpoint;Safety and tolerability; | — |
Countries
China
Contacts
Public ContactXiongjun Ye
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed