[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical study of hematoporphyrin ether ester injection for palliative treatment of severe obstructive symptoms in patients with primary esophageal cancer
主要研究目的:评估使用注射用血卟啉醚酯进行光动力疗法对比安慰剂在第7±1天时对中国原发性食管癌伴有重度食管梗阻的患者改善食管梗阻症状的疗效。次要研究目的包括:评价使用注射用血卟啉醚酯进行光动力治疗对患者长期吞咽困难的改善以及患者生活质量的改变以及对于肿瘤的影响,并评估安全性。
[Translation] The primary study objective is to evaluate the efficacy of photodynamic therapy with hematoporphyrin ether esters for injection compared with placebo in improving esophageal obstruction symptoms in Chinese patients with primary esophageal cancer and severe esophageal obstruction at 7±1 days. Secondary study objectives include: evaluating the improvement of long-term dysphagia and changes in patients' quality of life and the impact on tumors using photodynamic therapy with hematoporphyrin ether esters for injection, and evaluating safety.