Human (Autologous) Oral Mucosal Cell Sheet Transplantation After ESD in Patients With Superficial Esophageal Cancer
|ClinicalTrials.gov Identifier: NCT02866019|
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Superficial Esophageal Cancer||Device: CLS2702C/CLS2702D||Phase 3|
This study is a multicenter, single-arm, open-label study of CLS2702C/D in patients who plan to undergo ESD for superficial esophageal cancer.
In this study, the efficacy and safety of CLS2702C (cell sheet) transplanted (applied) to the wound site after ESD using CLS2702D (transplantation device) will be evaluated.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Multicenter, Open-label Study to Evaluate the Esophageal Stenosis Inhibition Effects and Safety of CLS2702C/CLS2702D After Endoscopic Submucosal Dissection (ESD) in Patients With Superficial Esophageal Cancer|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||February 2019|
|Actual Study Completion Date :||February 2019|
CLS2702C (cell sheet) will be transplanted to the wound site using CLS2702D (transplantation device) (screening period, 1 month [4 weeks]; cell sheet culture period, 0.5 month [16 days]; transplantation period, assessment/follow-up period, 6 months [24 weeks])
- Proportion of participants without stenosis until 8 weeks after endoscopic submucosal dissection (ESD) [ Time Frame: Up to 8 weeks after ESD ]
- Time to wound healing [ Time Frame: Up to 24 weeks after ESD ]Wound healing is defined as re-epithelized state with no white coat, erosion, or ulcer in the process of healing. The time to wound healing will be assessed endoscopically.
- Number of esophageal balloon dilatations (investigated until wound healing is confirmed) [ Time Frame: Up to 24 weeks ]Number of esophageal balloon dilatations will be counted.
- Number of participants reporting one or more adverse events and product deficiencies [ Time Frame: From day -16 to 24 weeks ]
An adverse event is defined as any untoward medical occurrence in a subject who has used the product or received the study treatment, regardless of the causal relationship with the product.
An adverse event can therefore be any untoward and unintended sign (including abnormal laboratory finding), symptom, or disease (new disease or worsening of an existing disease) temporally associated with the use of the product or implementation of the study treatment.
- Quality of Life (QOL) measured with the EORTC QLQ-C30 [ Time Frame: Up to 4 weeks ]The European Organization for Research and Treatment of Cancer QLQ-C30 is a quality-of-life instrument for use in international clinical trials in oncology. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale.
- QOL assessed by the EORTC QLQ-OG 25 [ Time Frame: Up to 24 weeks ]EORTC QLQ-OG25 questionnaire is a quality-of-life instrument for use in patients with esophagogastric cancers. The QLQ-OG25 has six scales, dysphagia, eating restrictions, reflux, odynophagia, pain and anxiety.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866019
|National Cancer Center Hospital East|
|Kashiwa-shi, Chiba, Japan, 277-8577|
|National Cancer Center Hospital|
|Chuo-ku, Tokyo, Japan, 104-0045|
|Tokyo Women's Medical University Hospital|
|Shinjuku-ku, Tokyo, Japan, 162-8666|