Renal
Conditions
Interventions
Experimental intervention group:Pazopanib(600mg,qd) and Chidamide(30mg,biw) and Adebrelimab(IV,20mg/Kg,q3w)
Sponsors
Fudan University Shanghai Cancer Center Urology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients must be fully informed and voluntarily sign an informed consent form; 2. Patients had to be aged 18 years or older; 3. Advance or metastasis of renal cancer, histologic confirmation of cell renal cell carcinoma; 4. Eastern Cooperative Oncology Group (ECOG) performance status below 2; 5. Patients with an estimated survival time >= 3 months; 6. The number of oligo metastases extracranial is less than or equal to 1, the lesion is detectable according to the RECIST 1.1 criteria; 7. Prior Anti-tumor Treatment Criteria: Disease progression occurred during or after systemic treatment with tyrosine kinase inhibitors or immune checkpoint inhibitors for locally advanced or metastatic RCC. Progression with tyrosine kinase inhibitor treatment is defined by meeting all of the following criteria: (a) The patient has received >=2 doses of a tyrosine kinase inhibitor. (b) Disease progression is determined by the investigator according to RECIST 1.1 criteria during or after tyrosine kinase inhibitor treatment. (c) Disease progression occurs within 12 weeks after the last dose of tyrosine kinase inhibitor treatment. Progression after first-line treatment without any subsequent systemic therapy; prior surgery, radiotherapy, chemotherapy, or other anti-tumor treatments must have been completed at least 4 weeks prior, with general physical condition or related adverse reactions recovered (toxicity =90×10^9/L; Hemoglobin >=90g/L; Total bilirubin (TBIL) =60ml/min/1.73m^2; Left ventricular ejection fraction (LVEF) >=50%; 9. Fridericia-corrected QT interval (QTcF) <470 milliseconds; INR <=1.5×ULN, APTT <=1.5×ULN.
Exclusion criteria
Exclusion criteria: 1.Prior use of HDAC inhibitors; 2.Meningeal metastasis confirmed by MRI or lumbar puncture; 3.Presence of clinically symptomatic ascites, pleural effusion, or pericardial effusion at baseline that requires drainage, or drainage of serous cavity effusion within 4 weeks before the first dose; 4.Participation in another new drug clinical trial within 4 weeks before enrollment; 5.History of other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin; 6.Concurrent receipt of any other anti-tumor treatment; 7.Other concurrent serious and/or uncontrolled diseases that may affect participation in the study, including any of the following: Inability to swallow, chronic diarrhea, and intestinal obstruction, with multiple factors affecting drug intake and absorption; Allergic constitution or known allergy to any component of the study drugs; History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; History of severe cardiac disease, including: ? myocardial infarction; ? heart failure; ? any other cardiac disease deemed unsuitable for participation in this trial by the investigator; Severe hypertension, diabetes, thyroid disease; Infection; 8.History of clear neurological or psychiatric disorders, including epilepsy or dementia; 9.Pregnant or breastfeeding women, women of childbearing age with a positive baseline pregnancy test, or women of childbearing age unwilling to take effective contraceptive measures throughout the trial period; 10.Any other situation deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Duration of Response;Disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactYe Dingwei
Fudan University Shanghai Cancer Center
Outcome results
None listed