A Prospective, Single Arm Clinical Study to Evaluate Efficacy and Safety of Lenvatinib Combined With Tislelizumab in the First Line Treatment of Patients With Locally Advanced or Metastastic Fumarate Hydratase Deficient Renal Cell Carcinoma
FHRCC is a rare kind of renal cell carcinoma with a morbidity of 1/2000000 per year.Although several combination therapies demonstrated possible efficacy in this population. No standard treatment has been approved. The purpose of this study is to evaluate the efficacy and safety of Lenvatinib in combination with tislelizumab in the first line treatment of patients with locally advanced/metastatic FHRCC.
• Fully understand and voluntarily sign the informed consent form and agree to receive treatment, examination and follow-up as required by the study protocol;
• Age ≥ 18, \< 80 years, male or female;
• ECOG score ≤2;
• unresectable or recurrent metastatic FH-deficient renal cell carcinoma not previously treated with systemic antitumor therapy, as confirmed by histology. Prior cytokine therapy is allowed;
• At least 1 measurable tumor lesion according to RECIST 1.1 criteria. The lesion that has received prior radiotherapy and progressed again is allowed as a target lesion;
• agree to provide blood and urine samples and previous archived or fresh tumor tissue samples.
• Demonstrates adequate organ function.
• Female subjects of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first dose. participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of study drug.