Early phase 2 clinical trial to evaluate efficacy and safety of GCP-002 (EP-HMRG) for patients of esophageal cancer

JRCT ID: jRCT2031240154

Registered date:11/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: esophageal cancer (squamous cell carcinoma)
• Date of first enrollment: 05/09/2024
• Target sample size: 6
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : EP-HMRG
INN of investigational material : GCP-002
Therapeutic category code : 729 Other diagnostic agents (except extracorporeal diagnostic medicines)
Dosage and Administration for Investigational material : Spraying 20mL of 50uM EP-HMRG solution in the esophagus using an endoscope.

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

Outcome(s)

• Primary Outcome: The performance (sensitivity, specificity, positive predictive value, negative predictive value, accuracy) of fluorescence diagnosis will be evaluated using pathological test results as a definitive diagnosis for specimens collected from the most fluorescent region and the non-fluorescent region in the vicinity of the region targeted for endoscopic treatment.
• Secondary Outcome: The performance of fluorescence diagnosis will be evaluated using pathological test results as a definitive diagnosis for newly discovered fluorescent sites outside the target area of endoscopic treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Male

Include criteria

1.Patients or legal representative who provide a signed document of informed consent for participation in
the study
2.Patients who are able to understand and comply with the contents of this clinical trial
3.Patients who are male
4.Patients aged 18 years or older at the time of informed consent
5.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 (2022 edition)
6.Patients who can be contraceptive using condoms and other contraceptive methods for 3 months after administration of investigational products

Exclude criteria

1. Patients aged 85 years or older
2. 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 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 liseases 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
3. Patients who received other investigational products within 3 months before the screening examination
4. Patients with a history of hypersensitivity to the ingredients of this drug and investigational drug
5. Patients who are planning to use a DPP-4 inhibitor within 28 days before administration of the study drug
6. Patients who the principal Investigator considers not suitable for this trial.

Related Information

• Primary Sponsor: Tsuji Yosuke