A Study to Evaluate the Esophageal Stenosis Inhibition Effects of CLS2702C/CLS2702D After Endoscopic Submucosal Dissection (ESD) in Patients With Superficial Esophageal Cancer in the Steroid Administration Risk Group

NCT04689594 | Terminated Phase 3

• 1 other identifier: CLS2702-ESO-02
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 in the steroid administration risk group.

Conditions

Superficial Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects without stenosis

  Proportion of participants without stenosis until 24 weeks after endoscopic submucosal dissection (ESD)

  24 weeks after endoscopic

Study Arms (1)

CLS2702C/CLS2702D

EXPERIMENTAL

Combination Product: CLS2702C/CLS2702D

Interventions

CLS2702C/CLS2702D COMBINATION_PRODUCT

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; transplantation and assessment period, 6 months \[24 weeks\]); follow-up period, 6 months \[24 weeks\]) Other Names: •Human (autologous) oral mucosal cell sheet •Transplantation device

CLS2702C/CLS2702D

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 a tumor diagnosed as \>=50% and \<100% of circumference, and with prediction that resection circumference will be \>=75% and \<100%.
• Patients with a tumor the major axis is \<=50 mm, and with prediction that a major axis of a resection will be \<=80 mm.
• 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 \<50%. However, if it is predicted that the major axis of the mucosal defect is \>80 mm due to treating the major and minor lesions and assembling ulcers after the treating, the patient is excluded.
• 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
• Patients in whom a commonly used endoscope with a tip diameter of 8.9 mm can pass
• Patients with a dysphagia score of 0
• Patients whose laboratory values within 28 days before enrolment meet all of the following criteria:
• White blood cell count: \>=4,000/microL

You may not qualify if:

• Patients with cardiac disease (myocardial infarction, unstable angina, and heart failure), renal disease (nephrotic syndrome and kidney failure)
• 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 except for topical corticosteroids (ointments and creams) and oral ointments or patches used for treating stomatitis after oral mucosal tissue taken from D-16 to D-1.
• Patients who are positive for any of serological test (HBs antigen, HBc antibody/HBs antibody, HCV antibody, HIV-1/2 antibody, HTLV-1 antibody, syphilis treponema antibody) or nucleic acid amplification test (HBV-DNA, HCV-RNA, HIV-RNA). However, this does not apply if the HBs antibody is positive and HBV-DNA is negative and the reason is clear that he was vaccinated with the hepatitis B vaccine.
• Patients with a mental disorder that is difficult to control
• Pregnant women, lactating women, and potentially pregnant women
• Patients who have participated in another clinical study within 6 months, those who are participating in another clinical study, and those who plan to participate in another clinical study during participation in this study
• Patients from whom tissues cannot be collected due to a disease (e.g., stomatitis, erosion, mass, and blister) in the oral mucosa at the tissue collection site
• Patients with a history of hypersensitivity to antibiotic preparations (ampicillin sodium, sulbactam sodium, streptomycin sulfate, gentamicin sulfate, or amphotericin B) or who have taken drugs that may affect the study (within 28 days before enrolment)

Sponsors & Collaborators

• CellSeed Inc.: lead

Study Sites (1)

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 30, 2020
• Study Start: February 4, 2021
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: March 27, 2026

Record last verified: 2024-01

Locations

JP (1)