Patients with locally relapsed or metastatic renal cancer who have previously received first-line treatment failure or intolerance
Conditions
Interventions
Test group:Adebrelimab+Axitinib
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Over 18 years of age, male or female; 2.Patients with locally relapsed or metastatic renal cancer who have previously received first-line treatment failure or intolerance (including TKI drug failure and disease progression using immunodrugs); 3.For the cohort who had previously received immunotherapy, the best evaluation of initial immunotherapy efficacy was required for patients who progressed after CR, PR, or SD=3 months. 4.The presence of at least one measurable lesion according to RECIST 1.1; 5.ECOG PS score: 0 ~ 2 points; 6.Estimated survival =12 weeks; 7.Have good organ function; 8.Fertile women should agree that effective contraception (such as Iuds, contraceptives, or condoms) must be used during the study period and for 6 months after the study ends; Have a negative serum pregnancy test within 72 hours before the first dose and must be non-lactating; Men should agree that effective contraception must be used during the study period and for 6 months after the end of the study period; 9.No active uncontrolled infection except for chronic viral hepatitis receiving antiviral therapy; 10.Patients voluntarily participated in this study and signed informed consent;
Exclusion criteria
Exclusion criteria: 1.Patients with contraindications to restart immunotherapy; 2.BMI 10 mg prednisone daily equivalent dose) within 2 weeks prior to initial use of the study drug. Other special circumstances, need to communicate with the sponsor. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone replacement at doses =10 mg/ day of prednisone efficacy are permitted; e. Those who have received anti-tumor vaccine or have received live vaccine within 4 weeks prior to the first administration of the investigational drug; f. Major surgery or severe trauma within 4 weeks prior to the first use of the study drug; 9.Severe infection (CTCAE > Grade 2) within 4 weeks prior to first use of the study drug; 10.History of interstitial lung disease (except radiation pneumonia without hormone therapy) and non-infectious pneumonia; 11.Patients with active pulmonary tuberculosis infection identified by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year ago but without formal treatment; 12.Pregnant or lactating women; A fertile patient who is unwilling or unable to take effective contraceptive measures; 13.Known allergy to the investigational drug or its excipients; 14.Any other factors deemed unsuitable for inclusion in the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Countries
China
Contacts
Public ContactDongyuan Zhu
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed