Hematoporphyrin Ether Ester

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.

(1) To evaluate the efficacy and safety of hematoporphyrin ether esters for injection in the palliative treatment of severe obstructive esophageal cancer, and to provide scientific and reliable clinical data for its drug registration in China. (2) To conduct a pharmacokinetic study of hematoporphyrin ether esters for injection in the palliative treatment of patients with severe obstructive esophageal cancer, to obtain the pharmacokinetic parameters of hematoporphyrin ether esters for injection in adult patients with esophageal cancer in China, and to provide scientific and reliable experimental basis for its drug registration in China.