Qinglong High-Tech Co., Ltd.

Cohort A: Primary purpose: To evaluate the safety of photodynamic therapy with sodium chaotoporphyrin for injection. Secondary purpose: Using local complete response rate (CRR) as the main evaluation index, explore the remission of sodium chaotoporphyrin for injection on local lesions of esophageal cancer. The effectiveness of sodium chaotoporphyrin for injection in patients with esophageal cancer was further evaluated by progression-free survival (PFS) and overall survival (OS). Cohort B: Primary purpose: To evaluate the safety of photodynamic therapy with sodium chaotoporphyrin for injection. Secondary purpose: Using local complete response rate (CRR) as the main evaluation index, explore the remission of sodium chaotoporphyrin for injection on local lesions of esophageal cancer. The effectiveness of sodium chaotoporphyrin for injection in patients with esophageal cancer was further evaluated by progression-free survival (PFS), health quality of life score and overall survival (OS).

IIIa: Using the treatment regimen selected by the researcher as the control, the objective response rate (ORR), duration of response (DOR), complete response rate (CRR), dysphagia symptom score and safety data of the target lesions in the esophageal lumen on the 28th day after treatment were comprehensively investigated to explore the optimal laser irradiation dose of sodium porphyrin for injection in patients with advanced esophageal cancer. IIIb: Main purpose: Based on the objective response rate (ORR) of the target lesions in the esophageal lumen on the 28th day after a single treatment, the effectiveness of sodium porphyrin for injection photodynamic therapy (PDT) compared with the treatment regimen selected by the researcher in patients with local recurrence or distant metastasis of esophageal cancer was evaluated. Secondary objectives: 1) To further evaluate the effectiveness of PDT for injection of esophageal cancer patients with local recurrence or distant metastasis by observing the changes in target lesions, dysphagia symptoms, duration of remission (DOR), progression-free survival (PFS), time to disease progression (TTP), quality of life, 6-month survival rate, 12-month survival rate, and overall survival compared with the treatment regimen selected by the investigator; 2) To evaluate the safety of PDT for injection of esophageal cancer patients with local recurrence or distant metastasis compared with the treatment regimen selected by the investigator.

Primary objective To optimize and verify the laser irradiation conditions of sodium thiocyanate for injection in patients with advanced esophageal cancer. Secondary objectives 1) To evaluate the remission of sodium thiocyanate for injection in target lesions in the esophageal lumen after single or multiple treatments in patients with advanced esophageal cancer; 2) To further evaluate the effectiveness of sodium thiocyanate for injection in target lesions in patients with advanced esophageal cancer by examining the symptoms of dysphagia, healthy quality of life, duration of remission, and overall survival.