Clinical trial · Interventional
Clinical Study of Time Optimizing of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer
Two-arm Phase III Trial Comparing Different Time of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer
NCT02628665CI-TRIAL-00020164unknownPhase 3ClinicalTrials.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)
The therapy of photofrin PDT was effective in improving life quality of patients with advanced esophageal and/or gastric cardiac cancer and the time optimizing for employing laser irradiation was of great importance.The purpose of this study is to evaluate the clinical efficacy and adverse effects of Photodynamic Therapy (PDT) on esophageal and/or gastric cardiac cancer during different time after inject photofrin.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage I Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage I Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage II Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage III Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 630 nm laser irradiation (DIOMED) | Device | — | UNRESOLVED |
| photosensitizer(photofrin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 24 to 48 hours group
- description
- photosensitizer(photofrin): 2mg/kg, Diomed Surgical Diode Laser:400mv/cm irridiation 750 seconds, 24 to 48 hours: The injection of photosensitizer(photofrin) 24 to 48 hours light irradiation power. 630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
- interventionNames
- Drug: photosensitizer(photofrin)
- Device: 630 nm laser irradiation (DIOMED)
- type
- ACTIVE_COMPARATOR
- label
- 48 to 72 hours group
- description
- photosensitizer(photofrin): 2mg/kg, Diomed Surgical Diode Laser:400mv/cm irridiation 750 seconds, 48 to 72 hours: The injection of photosensitizer(photofrin) 48 to 72 hours light irradiation power. 630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
- interventionNames
- Drug: photosensitizer(photofrin)
- Device: 630 nm laser irradiation (DIOMED)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * In the esophagus, patients with severe dysplasia and carcinoma in situ * The patients have not received the surgery or chemo-radiotherapy. * Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L, ALT、AST≤2.5\*N,Cr≤1.5\*N. * Performance status score 0-2 Exclusion Criteria: * pregnant, lactating women * History of organ transplantation * The peripheral nervous system disorders * Severe infection * Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding * Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes. * Other malignant tumor in recent 5 years.
References
Publications (2)
- BACKGROUNDLindenmann J, Matzi V, Neuboeck N, Anegg U, Baumgartner E, Maier A, Smolle J, Smolle-Juettner FM. Individualized, multimodal palliative treatment of inoperable esophageal cancer: clinical impact of photodynamic therapy resulting in prolonged survival. Lasers Surg Med. 2012 Mar;44(3):189-98. doi: 10.1002/lsm.22006. Epub 2012 Feb 14. PMID 22334351
- BACKGROUNDYano T, Muto M, Minashi K, Iwasaki J, Kojima T, Fuse N, Doi T, Kaneko K, Ohtsu A. Photodynamic therapy as salvage treatment for local failure after chemoradiotherapy in patients with esophageal squamous cell carcinoma: a phase II study. Int J Cancer. 2012 Sep 1;131(5):1228-34. doi: 10.1002/ijc.27320. Epub 2012 Mar 2. PMID 22024814