Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The investigators plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma or gastric cardia adenocarcinoma from the Oct.2015. The patients will be divided into two groups. Group 1: Following intravenous administration of photofrin at dose of 2 mg/kg.b.w. as the photosensitizer, 630 nm laser irradiation (DIOMED) with 400 mW/cm was applied on each part of tumor for 750 seconds through cylinder diffusing quartz fibers localizing in the biopsy channel of a flexible endoscope at 24th. Group 2: Following intravenous administration of photofrin at dose of 2 mg/kg.b.w. as the photosensitizer, 630 nm laser irradiation (DIOMED) with 400 mW/cm was applied on each part of tumor for 750 seconds through cylinder diffusing quartz fibers localizing in the biopsy channel of a flexible endoscope at 48th.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24 to 48 hours group | Experimental | 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. |
|
| 48 to 72 hours group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| photosensitizer(photofrin) | Drug | photosensitizer(photofrin): 2mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Partial remission rate | Photodynamic therapy for 3 months after the review of gastroscope for pathologic examination, to check the response rate | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The recent incidence of adverse reactions | Observe 7-10 days postoperatively in patients with the ratio of pain and difficulty swallowing | 7-10 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shegan Gao, Doctor | Contact | 18638859977 | gsg112258@163.com | |
| Tanyou Shan, Master | Contact | 18537976669 | shantanyou@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shegan Gao, Doctor | The First Affiliated Hospital of Henan University of Science and Technology | Study Chair |
| Tanyou Shan, Master | The First Affiliated Hospital of Henan University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | Henan | 471003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22334351 | Background | Lindenmann 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. | |
| 22024814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 630 nm laser irradiation (DIOMED) | Device | 630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds. |
|
|
| Caihong Dong, Master | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Xiaozhi Yuan, Master | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Lin Guo, Bachelor | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Lijuan Zhang, Bachelor | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Gailin Wang, Bachelor | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Yano 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. |
| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017323 | Dihematoporphyrin Ether |
| ID | Term |
|---|---|
| D017324 | Hematoporphyrin Derivative |
| D006415 | Hematoporphyrins |
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
Not provided
Not provided