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

CellSeed Inc.3 sites in 1 country10 target enrollmentApril 2016

ConditionsSuperficial Esophageal Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Superficial Esophageal Cancer
Sponsor: CellSeed Inc.
Enrollment: 10
Locations: 3
Primary Endpoint: Proportion of participants without stenosis until 8 weeks after endoscopic submucosal dissection (ESD)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of esophageal epithelial regenerative treatment by the transplantation of the product, CLS2702C, to the esophageal wound site after extensive ESD for superficial esophageal cancer.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

February 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CellSeed Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who plan to undergo ESD for the treatment of superficial esophageal cancer
•Patients aged ≥20 years at the time of consent
•Patients with no clinical metastasis (cN0M0) by cervical to abdominal CT
•Patients with an endoscopically diagnosed depth of wall invasion remaining in the epithelium (EP) or lamina propria mucosae (LPM)
•Patients with ≥3/4 of circumference and a length of \<8 cm
•If the patient has multiple lesions, the circumference of all minor lesions other than the one lesion with the largest circumference (major lesion) must be \<1/2, and the distance between the minor lesions and the major lesion must be 5 cm or more on the major axis.
•Patients with squamous cell carcinoma (including high-grade intraepithelial neoplasia) as confirmed by biopsy
•Patients whose lesion is confirmed to be localized in the thoracic esophagus (lesions in the cervical esophagus or abdominal esophagus will be excluded). The location of the lesion will be determined by endoscopy.
•Patients who have not received pretreatment for esophageal cancer. Treatment by ESD for superficial esophageal cancer for which the depth of wall invasion has been assessed to remain in the epithelium (EP) or lamina propria mucosae (LPM) is not included in the definition of pretreatment. However, patients who have a scar due to previous ESD in the major or minor lesions will be excluded from the study.
•Patients with an ECOG Performance Status (PS) of 0 or 1

Exclusion Criteria

•Patients with cardiac disease (myocardial infarction, unstable angina, and heart failure), renal disease (nephrotic syndrome and kidney failure), or poorly controlled diabetes mellitus
•Patients who have an active (within 1 year) malignancy other than esophageal cancer
•Patients with active bacterial, fungal, or viral infection
•Patients who are being treated with a corticosteroid
•Patients with positive HBs antigen, positive HCV antibody, positive HIV antibody, positive HTLV antibody, or positive Treponema pallidum (tested at screening). For patients with positive HBc/HBs antibody, HBV-DNA test will be performed (if the result is negative, the patient will be allowed to enter the study).
•Patients with a mental disorder that is difficult to control
•Pregnant women, lactating women, and potentially pregnant women
•Lactating women may be enrolled in the study if they discontinue lactation during the period from trans-plantation to confirmed wound healing.
•Women of childbearing potential must agree to use the following birth control methods or completely ab-stain from sexual intercourse during the period from consent to participate in the study to the end of study participation.
•Principal birth control methods: oral contraceptives, intrauterine contraceptive devices including intrauterine luteal hormone-releasing systems, tubal occlusion, and vasectomized partner

Outcomes

Primary Outcomes

Proportion of participants without stenosis until 8 weeks after endoscopic submucosal dissection (ESD)

Time Frame: Up to 8 weeks after ESD

Secondary Outcomes

QOL assessed by the EORTC QLQ-OG 25(Up to 24 weeks)
Number of esophageal balloon dilatations (investigated until wound healing is confirmed)(Up to 24 weeks)
Time to wound healing(Up to 24 weeks after ESD)
Number of participants reporting one or more adverse events and product deficiencies(From day -16 to 24 weeks)
Quality of Life (QOL) measured with the EORTC QLQ-C30(Up to 4 weeks)