Status:
UNKNOWN
HPPH Photodynamic Therapy for Patients With Esophageal Cancer
Lead Sponsor:
Zhejiang Hisun Pharmaceutical Co. Ltd.
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed 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 pl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 3 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 27 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03757754
Start Date
June 3 2015
End Date
May 27 2019
Last Update
November 29 2018
Active Locations (1)
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1
Department of Oncology, General Hospital of Beijing Miitary Command of PLA
Beijing, Beijing Municipality, China, 100010