HPPH Photodynamic Therapy for Patients With Esophageal Cancer

• Status: Unknown status
• Trial end date: 2019-05-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.

Criteria

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