esophageal cancer
Conditions
Sponsors
GORYO Chemical, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Patients or legal representative who provide a signed document of informed consent for participation in the study 2.Patients who are male 3.Patients whose consent date of this trial is 20 years old or over 4.Patients histologically diagnosed as esophageal cancer (squamous cell carcinoma) and judged to be suitable for endoscopic treatment based on Guidelines for Diagnosis and Treatment of Carcinoma of the Esophagus (2017 edition) 5.Patients who can be hospitalized by the date before treatment 6.Patients who can be contraceptive using condoms and other contraceptive methods for 3 months after administration of investigational products
Exclusion criteria
Exclusion criteria: 1.Patients whose consent date in this trial is 85 years old or over 2.Patients with a history of treatment for esophageal cancer 3.Patients with the following serious complications a.Patients with infections that require systemic treatment b.Patients who are being treated with continuous use of insulin or who have uncontrollable diabetes c.Patients with uncontrollable hypertension d.Patients with unstable angina (angina with onset or exacerbation within last 3 weeks) or a history of myocardial infarction within 6 months e.Patients with uncontrollable congestive heart failure or arrhythmia f.Patients who have pulmonary fibrosis and/or Interstitial pneumonia, whose complications or history of both diseases g.Patients who have difficulty in controlling bowel movements such as watery stool or chronic constipation h.Patients with hemorrhagic peptic ulcer, intestinal palsy, intestinal obstruction i.Patients with gastrointestinal dysfunction or gastrointestinal diseases except esophageal cancer j.Patients with acute kidney injury or uncontrolled kidney disease k.Patients who have psychosis or psychiatric symptoms and are considered difficult to participate in this trial 4.Patients who received other investigational products within 3 months before the screening examination 5.Patients who the principal Investigator or subinvestigator considers not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety To evaluate the safety of GCP-002 (EP-HMRG) in patients with esophageal cancer (squamous cell carcinoma). | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy To evaluate the efficasy of GCP-002 (EP-HMRG) . | — |
Countries
Japan
Outcome results
None listed