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HPPH Photodynamic Therapy for Patients With Esophageal Cancer — HPPH  

Esophageal Cancer Clinical Trial

Official title:
Evalution of Safety, Tolerability and Pharmacokinetics of of HPPH in Ascending Dose for Cancer Patients in Phase I Clinical Trial

Clinical Trial Summary

Phase I study was to investigate the safety and tolerability of the photosensitizer (PS) 2-[1-hexyloxyethyl]-2-devinyl pyropheophorbide-a (HPPH) for injection in patients with Esophageal Cancer. It was to characterize the pharmacokinetics of HPPH and efficacy of HPPH.

Clinical Trial Description

The present study is phase I study to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending injection doses of HPPH in Patients with Esophageal Cancer. Up to 30 patients are planned to be enrolled in 6 cohorts with each cohort consisting of 3-6 patients ( male and/or female patients). In each cohort, patients will receive HPPH and Lyophilized treatment. The dose escalation in Cohorts was from 2.5 to 3, 3.5, 4, 5, and 6mg/m2 of HPPH, respectively, administered intravenous drop infusion over 1 hour, once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03757754
Study type Interventional
Source Zhejiang Hisun Pharmaceutical Co. Ltd.
Contact
Status Active, not recruiting
Phase Phase 1
Start date June 3, 2015
Completion date May 27, 2019
View Details
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