[Translation] A single-arm, open-label, multiplex study to evaluate the efficacy and safety of recombinant carboxypeptidase G2 for injection in reducing methotrexate plasma concentrations in osteosarcoma patients with delayed methotrexate excretion following high-dose methotrexate chemotherapy Center for Clinical Trials
(1)主要目的:评价注射用重组羧肽酶G2治疗使用大剂量甲氨蝶呤化疗(>500mg/m2 BSA)后出现甲氨蝶呤排泄延迟患者的有效性和安全性。
(2)次要目的:评价注射用重组羧肽酶G2在使用大剂量甲氨蝶呤化疗后出现甲氨蝶呤排泄延迟患者的药代动力学(PK)特征。
[Translation] (1) Main purpose: To evaluate the efficacy and safety of recombinant carboxypeptidase G2 for injection in patients with delayed methotrexate excretion after high-dose methotrexate chemotherapy (>500 mg/m2 BSA).
(2) Secondary objective: To evaluate the pharmacokinetics (PK) characteristics of recombinant carboxypeptidase G2 for injection in patients with delayed methotrexate excretion after high-dose methotrexate chemotherapy.