Status:
NOT_YET_RECRUITING
Envafolimab Combined With Axitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Advanced Renal Cell Carcinoma (aRCC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Introduction: This document explains a clinical research study conducted at Peking Union Medical College Hospital. The study aims to evaluate a new combination treatment - Envafolimab (an immunothera...
Eligibility Criteria
Inclusion
- 1\. Sign an informed consent form in writing; 2. Age between 18 and 75 years old; 3. Unresectable or metastatic clear cell renal cell carcinoma; 4. No prior systemic anti-tumor treatment; 5. Measurable disease according to RECIST v1.1; 6. ECOG performance status: 0 to 1; 7. Adequate organ and bone marrow function:
- Complete blood count: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10\^9/L, Platelet (PLT) count ≥ 70 × 10\^9/L, Hemoglobin (HGB) ≥ 90 g/L;
- Liver function: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤ 3 × ULN; Serum Albumin ≥ 28 g/L; Alkaline Phosphatase (ALP) ≤ 5 × ULN; subjects who meet the above criteria after routine liver protection treatment and have been stable for at least one week after assessment by the researcher can be enrolled;
- Renal function: Serum Creatinine (Cr) ≤ 1.5 × ULN, or Creatinine Clearance ≥ 50 mL/min (using the standard Cockcroft-Gault formula);
- Coagulation function: International Normalized Ratio (INR) ≤ 1.5 / Prothrombin Time (PT) ≤ 1.5 × ULN, Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN; if the subject is undergoing anticoagulant therapy, as long as PT and INR are within the range specified for the anticoagulant medication, they are eligible.
- 8\. Estimated life expectancy ≥ 6 months; 9. Subjects voluntarily participate in this study and have good compliance.
Exclusion
- 1\. A history of or concurrent with other malignant tumors; 2. Patients who have previously received systemic anti-tumor treatment; 3. Known allergies to macromolecular protein preparations or components of the study medication in the subject's history; 4. Active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) have occurred within 2 years prior to the first dose of the study medication. Replacement therapies (such as thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatment; 5. Receiving systemic corticosteroid treatment (excluding nasal, inhalation, or other local routes of administration) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study medication; Note: The use of physiological doses of corticosteroids (equivalent to ≤50 mg/day of hydrocortisone or equivalent) is permitted; 6. The subject has been using traditional Chinese medicine or other immunomodulators within 2 weeks prior to enrollment; 7. Symptomatic ascites or pleural effusion that cannot be controlled with medication and requires therapeutic puncture or drainage; 8. Uncontrolled cardiac clinical symptoms or diseases, such as:
- Heart failure at NYHA class 2 or above;
- Unstable angina;
- Myocardial infarction within the past year;
- Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 9. Known history of abuse of psychiatric drugs, alcoholism, or drug addiction in the subject; 10. Pregnant or nursing women; 11. Men or women of childbearing potential (referring to men or women who have not undergone sterilization surgery, as well as women who have not reached menopause) must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, abstinence, or barrier contraception combined with spermicides) during the trial and continue to use contraceptives for 6 months after the last dose; 12. The investigator deems that the subject should be excluded from this study, for example, if the investigator judges that the subject has other factors that may force the study to be terminated prematurely, such as other serious diseases (including psychiatric diseases) requiring concurrent treatment, severe laboratory test abnormalities, or family or social factors that may affect the subject's safety or the collection of data and samples.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 20 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07159191
Start Date
September 1 2025
End Date
July 20 2027
Last Update
September 8 2025
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