Determine the safety and tolerability of a single dose in humans; describe the pharmacokinetic laws of the drug and its metabolites in humans after a single dose and calculate pharmacokinetic parameters, analyze the relationship between pharmacokinetic parameters and toxicity, and preliminarily explore PK-PD; provide a safe and effective reasonable dosing test plan for Phase II clinical studies.

Start Date-

Sponsor / Collaborator-

CTR20150429 / RecruitingPhase 2

评价用福大赛因注射液光动力治疗完全或不完全梗阻原发性食管癌患者有效性安全性的开放多中心II期临床试验

[Translation] An open multicenter phase II clinical trial to evaluate the effectiveness and safety of photodynamic therapy with forsine injection in patients with complete or incomplete obstruction of primary esophageal cancer

主要目的：评价福大赛因注射液对于改善食管阻塞和吞咽困难症状的疗效。次要目的：评价福大赛因注射液治疗前后肿瘤病灶缩小情况；评价福大赛因注射液治疗前后生活质量改善情况；评价福大赛因注射液治疗的安全性及潜在操作风险的控制。

[Translation]

Primary objective: To evaluate the efficacy of Fosdaigin injection in improving esophageal obstruction and dysphagia. Secondary objectives: To evaluate the reduction of tumor lesions before and after Fosdaigin injection treatment; to evaluate the improvement of quality of life before and after Fosdaigin injection treatment; to evaluate the safety of Fosdaigin injection treatment and the control of potential operational risks.

Start Date08 Oct 2016

Sponsor / Collaborator

Fuzhou University

[+1]

100 Clinical Results associated with Suftalan Zinc

100 Translational Medicine associated with Suftalan Zinc

100 Patents (Medical) associated with Suftalan Zinc

100 Deals associated with Suftalan Zinc

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Esophageal Carcinoma	Phase 2	CN	Fujian Longhua Pharmaceutical Co., Ltd.	08 Oct 2016
Esophageal Carcinoma	Phase 2	CN	Fuzhou University	08 Oct 2016
Advanced cancer	Discovery	CN	-	31 Oct 2013

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