[Translation] A multicenter, randomized, open-label, parallel-controlled phase III clinical trial comparing the efficacy and safety of lutetium [177Lu]oxyoctreotide injection with long-acting octreotide in adult subjects with unresectable or metastatic, somatostatin receptor-positive gastrointestinal pancreatic neuroendocrine tumors
主要目的:
评估镥[177Lu]氧奥曲肽注射液对比高剂量长效奥曲肽,在不可手术切除或转移性、生长抑素受体阳性的成人胃肠胰神经内分泌瘤受试者中的有效性。
次要目的:
评估镥[177Lu]氧奥曲肽注射液对比高剂量长效奥曲肽,在不可手术切除或转移性、生长抑素受体阳性的成人胃肠胰神经内分泌瘤受试者
中的安全性;
评估镥[177Lu]氧奥曲肽注射液的药代动力学和辐射剂量学特征。
[Translation] Primary objective:
To evaluate the efficacy of lutetium [177Lu] oxyoctreotide injection versus high-dose long-acting octreotide in adult subjects with unresectable or metastatic, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
Secondary objectives:
To evaluate the safety of lutetium [177Lu] oxyoctreotide injection versus high-dose long-acting octreotide in adult subjects with unresectable or metastatic, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors;
To evaluate the pharmacokinetics and radiation dosimetry characteristics of lutetium [177Lu] oxyoctreotide injection.