[Translation] A randomized, open, positive-controlled, multicenter phase 2 clinical study comparing mitoxantrone hydrochloride liposome injection combined with capecitabine and capecitabine alone in subjects with recurrent metastatic nasopharyngeal carcinoma who have failed platinum-based treatment
主要研究目的:
评价盐酸米托蒽醌脂质体注射液联合卡培他滨对比卡培他滨单药治疗在复发转移性鼻咽癌受试者中的有效性。 次要研究目的:
评价盐酸米托蒽醌脂质体注射液联合卡培他滨对比卡培他滨单药治疗在复发转移性鼻咽癌受试者中的有效性和安全性;
评价盐酸米托蒽醌脂质体注射液的药代动力学(PK)特征。
[Translation] Main study objectives:
To evaluate the efficacy of mitoxantrone hydrochloride liposome injection combined with capecitabine versus capecitabine monotherapy in subjects with recurrent metastatic nasopharyngeal carcinoma. Secondary study objectives:
To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with capecitabine versus capecitabine monotherapy in subjects with recurrent metastatic nasopharyngeal carcinoma;
To evaluate the pharmacokinetic (PK) characteristics of mitoxantrone hydrochloride liposome injection.