HPPH Photodynamic Therapy for Patients With Esophageal Cancer

Hisun Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Esophageal Cancer

Treatments: Drug: HPPH 2.5 mg/m2; Drug: HPPH 3.5 mg/m2; Drug: HPPH 3 mg/m2; Drug: HPPH 6 mg/m2; Drug: HPPH 5 mg/m2; Drug: HPPH 4 mg/m2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03757754

HISUN-HPPH-I-2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 6 patient groups

HPPH 2.5 mg/m2

Experimental group

Description:

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.

Treatment:

Drug: HPPH 2.5 mg/m2

HPPH 3 mg/m2

Experimental group

Description:

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.

Treatment:

Drug: HPPH 3 mg/m2

HPPH 3.5 mg/m2

Experimental group

Description:

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.

Treatment:

Drug: HPPH 3.5 mg/m2

HPPH 4 mg/m2

Experimental group

Description:

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.

Treatment:

Drug: HPPH 4 mg/m2

HPPH 5 mg/m2

Experimental group

Description:

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.

Treatment:

Drug: HPPH 5 mg/m2

HPPH 6 mg/m2

Experimental group

Description:

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.

Treatment:

Drug: HPPH 6 mg/m2