A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread

Prior treatment

• History of or concurrent other malignancies, except for appropriately treated carcinoma in situ or non-melanoma skin cancer with evidence of cure.
• Prior systemic antitumor therapy for advanced disease (including antiangiogenic agents and immunotherapy), with the exception of palliative radiotherapy or preoperative PD-1 neoadjuvant therapy.
• Known history of hypersensitivity to any component of the investigational drug products.
• Administration of live vaccines within 4 weeks prior to the first dose of study treatment or anticipated during the study period.

Other illness

• Poorly controlled cardiac symptoms or diseases, including: (1) heart failure of New York Heart Association (NYHA) Class II or higher; (2) unstable angina pectoris; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
• Active infection, or unexplained fever \> 38.5°C occurring during the screening period or before the first dose (subjects with fever determined by the investigator to be tumor-related may be enrolled).
• History of substance abuse, drug addiction, or chronic alcohol abuse.
• Active hepatitis B infection.
• Active systemic autoimmune diseases.

Lab values

• Any condition that, in the judgment of the investigator, would preclude participation in the study. This includes severe concomitant conditions (including psychiatric disorders) requiring treatment, significant laboratory abnormalities, or social/familial factors that could compromise subject safety or adherence to protocol requirements, including data and sample collection

Other

• Presence of metastatic lesions meeting any of the following: unifocal organ metastasis numbering more than 3, or total systemic metastatic foci exceeding 5.
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• Subjects must meet all of the following criteria to be eligible for enrollment in the study:
• Provide written informed consent prior to any study-specific procedures.
• Aged between 18 and 75 years, inclusive.
• Histologically confirmed clear cell renal cell carcinoma with radiologically documented liver metastases, and having received no prior systemic antitumor therapy.
• Presence of at least one measurable liver metastasis lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (with the longest diameter ≥ 10 mm on computed tomography scan for non-lymph node lesions).
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Life expectancy of ≥ 3 months.
• Voluntarily agree to participate in the study with good compliance.
• Adequate organ and bone marrow function, defined as follows:
• Hematological:Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 70 × 10⁹/L; Hemoglobin (HGB) ≥ 90 g/L.
• Hepatic:Serum total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; Serum albumin ≥ 28 g/L; Alkaline phosphatase (ALP) ≤ 5 × ULN. (Subjects who meet the above criteria after conventional liver-protecting therapy and remain stable for at least one week, as assessed by the investigator, may be enrolled.)
• Renal:Serum creatinine (Cr) ≤ 1.5 × ULN, or calculated creatinine clearance ≥ 50 mL/min (using the standard Cockcroft-Gault formula).
• Coagulation:International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN, and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. (For subjects receiving anticoagulant therapy, enrollment is permitted if the PT and INR are within the therapeutic range intended by the anticoagulant medication.)