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Superficial Esophageal CancerPhase 3NCT02866019

Human (Autologous) Oral Mucosal Cell Sheet Transplantation After ESD in Patients With Superficial Esophageal Cancer

A Phase 3 study testing CLS2702C/CLS2702D in people with Superficial Esophageal Cancer, run by CellSeed Inc. at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesJapan
Study dates
Apr 2016to Feb 2019
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 ≥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.
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  • 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/µL
  • Platelet count: ≥100,000/µL
  • 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

Who cannot join

  • 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
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  • 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
  • Supportive birth control methods: condoms and diaphragms
  • The use of principal birth control methods is essential. Supportive birth control methods should not be used alone and must be used together with the principal birth control methods. For oral contraceptives, changes in the birth control methods or other strategies should be considered because it is known that their effect is reduced if they are missed or concomitantly taken with certain types of drugs or dietary supplements.
  • 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 Study CLS2702-ESO-01
  • 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)
  • Patients who have undergone radiotherapy in the cervical to upper abdominal region, or surgery for head and neck cancer that may affect the assessment of ESD or stenotic symptoms
  • Patients whose swallowing function has been markedly reduced or completely lost due to a sequela of cerebral infarction or other reasons
  • Patients with porcine or latex allergy
  • Patients who, in the opinion of the treating physician, are not eligible for the study due to reasons other than those described above

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo, 162-8666

Other trials in Japan

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

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.

Read the 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.

Being tested
CLS2702C/CLS2702D

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CLS2702C/CLS2702DDevice

    Also called Human (autologous) oral mucosal cell sheet, Transplantation device

    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])

Study groups in NCT02866019
Study groupRoleWhat they receive
CLS2702C/CLS2702DExperimentalNot described
Receives: Device: CLS2702C/CLS2702D

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 8 weeks after ESD

Secondary outcomes (5)

  1. Time to wound healing

    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.

    Measured: Up to 24 weeks after ESD

  2. Number of esophageal balloon dilatations (investigated until wound healing is confirmed)

    Number of esophageal balloon dilatations will be counted.

    Measured: Up to 24 weeks

  3. Number of participants reporting one or more adverse events and product deficiencies

    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.

    Measured: From day -16 to 24 weeks

  4. Quality of Life (QOL) measured with the EORTC QLQ-C30

    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.

    Measured: Up to 4 weeks

  5. QOL assessed by the EORTC QLQ-OG 25

    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.

    Measured: Up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionFeb 2019
  4. Study completionFeb 2019

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866019
Sponsor's protocol ID
CLS2702-ESO-01
Status last verified
Feb 2019
First submitted
5 Aug 2016
Last updated
7 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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 3 sites 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 20 inclusion and 19 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: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 participants without stenosis until 8 weeks after endoscopic submucosal dissection (ESD) (time frame: Up to 8 weeks after ESD). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02866019.

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 7 Mar 2019.

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