Safety and efficacy of photodynamic therapy using ME2906 and PNL6405GST for gastric cancer in patients who cannot undergo surgery or endoscopic resection

Safety and efficacy of photodynamic therapy using ME2906 and PNL6405GST for gastric cancer in patients who cannot undergo surgery or endoscopic resection - Safety and efficacy of photodynamic therapy for gastric cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032398

Enrollment

Registered

2018-05-01

Start date

2018-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

Photodynamic therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with clinical stage IA gastric cancer (2) The size of tumor fulfilled any condition shown below, confirmed by EGD performed within 28 days before the photodynamic therapy (A) The size of tumor was 1-3 centimeter diameter without ulceration (B) The size of tumor was less than 2 centimeter with ulceration (3) The whole tumor can be observed and can be irradiated stably (4) No lymph node metastasis evaluated by CT performed within 28 days before the photodynamic therapy (5) Patients cannot undergo surgery or endoscopic resection (6) Patients whom a written consent can be obtained

Exclusion criteria

Exclusion criteria: (1) Patients having active multiple cancers except gastric cancer (2) Patients who cannot undergo EGD safely (A) Patients in the shock state (B) Patients with disseminated intravascular coagulation (C) Patients with desaturation (SpO2 < 90%) even under oxygen administration (D) Patients with thrombocytopenia (< 10000 / micro-liter) (E) Performance status 4 (F) Patients with heart failure (NYHA class IV) (G) Patients with angina pectoris (CSS grade IV) (H) Patients with severe valvular disease of heart (I) Patients with pulmonary hypertension (WHO classification group 4) (J) Patients with ventilatory impairment (both FEV1.0% and %VC < 60%) (K) Patients with severe bronchial asthma (L) Patients with coagulopathy (PT-INR > 3.0) (3) Patients who cannot tolerate shading (4) Patients with porphyria (5) Patients with photosensitivity (6) Patients had PDT therapy previously (7) Patients in pregnancy (8) Nursing patients (9) Patients with severe liver failure (Child-Pugh classification class C) (10) Patients enrolling another clinical trial or within 3 months after the completion of enrollment of another clinical trial (11) Patients who were not suitable for the study

Design outcomes

Primary

Measure	Time frame
To decide maximum tolerated dose of irradiation fluence (50, 75 or 100 J/cm2) to evaluate dose limited toxicity	—

Countries

Japan

Contacts

Public ContactShiko Kuribayashi

Gunma University Hospital Division of Gastroenterology and Hepatology

shikokuri@gunma-u.ac.jp027-220-8137

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026