Superficial Esophageal CancerPhase 3NCT04689594
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
A Phase 3 study testing CLS2702C/CLS2702D in people with Superficial Esophageal Cancer, run by CellSeed Inc. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Superficial Esophageal Cancer
- What is being tested?
- CLS2702C/CLS2702D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteJapan
- Study dates
- 4 Feb 2021to 20 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- Platelet count: >=100,000/microL
- AST: <=100 IU/L
- ALT: <=100 IU/L
- Total bilirubin: <=2.0 mg/dL
- Serum creatinine: <=2.0 mg/dL
- Patients who have received sufficient explanation about the study and provided written voluntary consent.
- Patients who meet any of the following criteria:
- With fibrous nodule shadow on IGRA negative diagnostic imaging
- Required continuous systemic administration of immunosuppressants
- With diabetes with blood glucose level of 180 mg/dL or more 2 hours after meal even with insulin
- With 7.0% or more of hemoglobin A1c (HbA1c, (International standard value (NGSP value)) even if taking 2 or more drug treatments for more than 3 months
- With high blood pressure which does not reach the target value even if taking 2-3 antihypertensive drugs or reach it with 4 or more antihypertensive drugs
- With glaucoma, posterior capsule cataract or herpes simplex keratitis (Ophthalmology consultation is not mandatory)
- With a risk of administration of corticosteroids based on medical judgment.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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 in the Steroid Administration Risk Group
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
- Being tested
- CLS2702C/CLS2702D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLS2702C/CLS2702DCombination 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
| Study group | Role | What they receive |
|---|---|---|
| CLS2702C/CLS2702D | Experimental | Not described Receives: Combination Product: CLS2702C/CLS2702D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects without stenosis
Proportion of participants without stenosis until 24 weeks after endoscopic submucosal dissection (ESD)
Measured: 24 weeks after endoscopic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start4 Feb 2021
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- CellSeed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689594
- Sponsor's protocol ID
- CLS2702-ESO-02
- Status last verified
- Jan 2024
- First submitted
- 28 Dec 2020
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 in the Steroid Administration Risk Group
- ClinicalTrials.gov ID
- NCT04689594
- Acronym / sponsor ID
- CLS2702-ESO-02
- Conditions
- Superficial Esophageal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- CellSeed Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLS2702C/CLS2702D | Experimental | Combination Product: CLS2702C/CLS2702D |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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%.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLS2702C/CLS2702DCLS2702C (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 | Combination product | CLS2702C/CLS2702D |
Primary outcome
Proportion of subjects without stenosis
Time frame: 24 weeks after endoscopic
Proportion of participants without stenosis until 24 weeks after endoscopic submucosal dissection (ESD)
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CLS2702C/CLS2702D in people with Superficial Esophageal Cancer, run by CellSeed Inc. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects without stenosis (time frame: 24 weeks after endoscopic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.