HPPH Photodynamic Therapy for Patients With Esophageal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-03

Study Completion Date

2019-05-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Multiple Ascending Dose, Multiple groups, Multiple centers

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open

Study Groups

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HPPH 2.5 mg/m2

HPPH 2.5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.

Group Type EXPERIMENTAL

HPPH 2.5 mg/m2

Intervention Type DRUG

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.

HPPH 3 mg/m2

HPPH 3 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.

Group Type EXPERIMENTAL

HPPH 3 mg/m2

Intervention Type DRUG

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.

HPPH 3.5 mg/m2

HPPH 3.5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.

Group Type EXPERIMENTAL

HPPH 3.5 mg/m2

Intervention Type DRUG

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.

HPPH 4 mg/m2

HPPH 4 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.

Group Type EXPERIMENTAL

HPPH 4 mg/m2

Intervention Type DRUG

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.

HPPH 5 mg/m2

HPPH 5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.

Group Type EXPERIMENTAL

HPPH 5 mg/m2

Intervention Type DRUG

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.

HPPH 6 mg/m2

HPPH 6 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.

Group Type EXPERIMENTAL

HPPH 6 mg/m2

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older, Male and female subjects with practicing a highly effective form of birth control, and a signed consent;
* Subjects who was diagnosed as Esophageal Cancer or carcinoma of gastric cardia by endoscopy and Biopsy pathology at T1-T3 stage.
* Subjects who could not be taken surgery or chemotherapy; with unsucessful surgery or failed chemotherapy; who had refused surgery and chemotherapy
* ECOG 0-2, Life expectancy would be more than 3-month

Exclusion Criteria

* Subjects were diagnosed as Tracheoesophageal fistula or Esophageal mediatinal fistula, or more than 60 years old with having three kinds of Heart, Lung, Liver and Kidney commorbities;
* Hematopoietic WBC \< 3×109/L; HGB \<80g/L; PLT \<80×109/L; PLT \<1.5 times upper limit of normal (ULN)
* Hepatic TBIL\>1.5ULN, ALT or AST \>2.5 ULN
* Alkaline phosphatase \> 3 times ULN
* Uncontrol Hypertension: Bp\>160/100mmHg
* Uncomtrol Diabetes

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No