A Study to Evaluate the Esophageal Stenosis Inhibition Effects of CLS2702C/CLS2702D After Endosco… (NCT04689594) | Clinical Trial Compass
TerminatedPhase 3
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
Stopped: Due to the extension of the clinical trial period due to a problem that occurred in the first patient of this study, there were concerns about business viability, so we decided to cancel this study.
Japan1 participantsStarted 2021-02-04
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
Exclusion criteria
. 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