[Translation] A randomized, open-label, multicenter phase II clinical trial evaluating the efficacy and safety of E10H combined with IgG1 antibody and chemotherapy as first-line treatment for patients with advanced gastrointestinal cancer.
胃癌组主要目的:
(1)探索E10H联合曲妥珠单抗和XELOX在晚期转移性HER2阳性胃癌患者中的初步疗效。
(2)评价E10H联合曲妥珠单抗和XELOX在晚期转移性HER2阳性胃癌患者中的安全性和耐受性。
次要目的:
评价E10H联合曲妥珠单抗和化疗在晚期转移性HER2阳性胃癌患者中多次给药的药代动力学/药效动力学(PK/PD)特征。 结直肠癌组主要目的:
(1)探索E10H联合西妥昔单抗/贝伐珠单抗和FOLFOX在转移性结直肠癌患者中的初步疗效。
(2)评价E10H联合西妥昔单抗/贝伐珠单抗和FOLFOX在转移性结直肠癌患者中的安全性和耐受性。
次要目的:
评价E10H联合西妥昔单抗/贝伐珠单抗和FOLFOX在转移性结直肠癌患者中多次给药的药代动力学/药效动力学(PK/PD)特征
[Translation] Primary objectives of the gastric cancer group:
(1) To explore the preliminary efficacy of E10H in combination with trastuzumab and XELOX in patients with advanced metastatic HER2-positive gastric cancer.
(2) To evaluate the safety and tolerability of E10H in combination with trastuzumab and XELOX in patients with advanced metastatic HER2-positive gastric cancer.
Secondary objectives: To evaluate the pharmacokinetic/pharmacodynamic (PK/PD) characteristics of multiple-dose administration of E10H in combination with trastuzumab and chemotherapy in patients with advanced metastatic HER2-positive gastric cancer.
Primary objectives of the colorectal cancer group:
(1) To explore the preliminary efficacy of E10H in combination with cetuximab/bevacizumab and FOLFOX in patients with metastatic colorectal cancer.
(2) To evaluate the safety and tolerability of E10H in combination with cetuximab/bevacizumab and FOLFOX in patients with metastatic colorectal cancer. Secondary objective: To evaluate the pharmacokinetic/pharmacodynamic (PK/PD) characteristics of E10H in combination with cetuximab/bevacizumab and FOLFOX in patients with metastatic colorectal cancer after multiple dosing.