Clinical trial NCT03757754: HPPH Photodynamic Therapy for Patients With Esophageal Cancer
Official title: Evalution of Safety, Tolerability and Pharmacokinetics of of HPPH in Ascending Dose for Cancer Patients in Phase I Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Esophageal Cancer
Keywords: PHHP
Esophageal cancer
Phase I study
Lead sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Multiple Ascending Dose, Multiple groups, Multiple centers
Primary purpose: TREATMENT

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 was to characterize the pharmacokinetics of HPPH and efficacy of HPPH.

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 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.

Eligibility 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

Primary outcomes:
measure: The number of dose-limiting toxicity
timeFrame: Day 1 to Day 10
Secondary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Day 1 to Day 84
measure: Time to maximum concentration (tmax)
timeFrame: Day 1 to Day 84
measure: Apparent terminal elimination phase half (t1/2)
timeFrame: Day 1 to Day 84
measure: Area under the concentration-time curve over the dosing interval (AUC0-t)
timeFrame: Day 1 to Day 84
measure: Area under the concentration-time curve from zero extrapolated to infinity (AUC0-∞)
timeFrame: Day 1 to Day 84
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Oncology, General Hospital of Beijing Miitary Command of PLA
state: Beijing
Study officials:
affiliation: General Hospital of Beijing Miitary Command of PLA
name: Huilong Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: