HPPH Photodynamic Therapy for Patients With Esophageal Cancer
- Conditions
- Esophageal Cancer
- Interventions
- Registration Number
- NCT03757754
- Lead Sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description HPPH 2.5 mg/m2 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. HPPH 3 mg/m2 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. HPPH 3.5 mg/m2 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. HPPH 4 mg/m2 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. HPPH 5 mg/m2 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. HPPH 6 mg/m2 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.
- Primary Outcome Measures
Name Time Method The number of dose-limiting toxicity Day 1 to Day 10 Dose-limiting toxicity would be assesed by CTCAE4.0
- Secondary Outcome Measures
Name Time Method Apparent terminal elimination phase half (t1/2) Day 1 to Day 84 PK measurement expressed as t1/2 for HPPH
Area under the concentration-time curve over the dosing interval (AUC0-t) Day 1 to Day 84 PK measurement expressed as AUC0-t for HPPH
Area under the concentration-time curve from zero extrapolated to infinity (AUC0-∞) Day 1 to Day 84 PK measurement expressed as AUC0-∞ for HPPH
Maximum observed concentration (Cmax) Day 1 to Day 84 PK measurement expressed as Cmax for HPPH
Time to maximum concentration (tmax) Day 1 to Day 84 PK measurement expressed as Tmax for HPPH
Trial Locations
- Locations (1)
Department of Oncology, General Hospital of Beijing Miitary Command of PLA
🇨🇳Beijing, Beijing, China