A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread (NCT07256223) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread
30 participantsStarted 2025-12-01
Plain-language summary
This is an open-label, single-arm, prospective, multicenter clinical study designed to evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases. The Department of Urology at Fudan University Shanghai Cancer Center serves as the primary research center.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
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-G…