Clinical trial · Interventional
HPPH Photodynamic Therapy for Patients With Esophageal Cancer
Evalution of Safety, Tolerability and Pharmacokinetics of of HPPH in Ascending Dose for Cancer Patients in Phase I Clinical Trial
NCT03757754CI-TRIAL-00035967HPPHunknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPPH 2.5 mg/m2 | Drug | — | UNRESOLVED |
| HPPH 3.5 mg/m2 | Drug | — | UNRESOLVED |
| HPPH 3 mg/m2 | Drug | — | UNRESOLVED |
| HPPH 4 mg/m2 | Drug | — | UNRESOLVED |
| HPPH 5 mg/m2 | Drug | — | UNRESOLVED |
| HPPH 6 mg/m2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- HPPH 2.5 mg/m2
- 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.
- interventionNames
- Drug: HPPH 2.5 mg/m2
- type
- EXPERIMENTAL
- label
- HPPH 3 mg/m2
- 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.
- interventionNames
- Drug: HPPH 3 mg/m2
- type
- EXPERIMENTAL
- label
- HPPH 3.5 mg/m2
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.