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HPPH Photodynamic Therapy for Patients With Esophageal Cancer

NCT03757754 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-11-29

No results posted yet for this study

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.

Conditions

  • Esophageal Cancer

Interventions

DRUG

HPPH 2.5 mg/m2

HPPH was administered as a single, 2.5 mg/m2, slow intravenous infusion over 1 hour , and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.

DRUG

HPPH 3 mg/m2

HPPH was administered as a single, 3 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.

DRUG

HPPH 3.5 mg/m2

HPPH was administered as a single, 3.5 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.

DRUG

HPPH 4 mg/m2

HPPH was administered as a single, 4 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.

DRUG

HPPH 5 mg/m2

HPPH was administered as a single, 5 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.

DRUG

HPPH 6 mg/m2

HPPH was administered as a single, 6 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.

Sponsors & Collaborators

  • Zhejiang Hisun Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Huilong Liu, PhD · General Hospital of Beijing Miitary Command of PLA

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-03
Primary Completion
2019-01-20
Completion
2019-05-27

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03757754 on ClinicalTrials.gov