Safety and efficacy of photodynamic therapy using ME2906 and PNL6405GST for gastric cancer in patients who cannot undergo surgery or endoscopic resectio
- Conditions
- Gastric cancer
- Registration Number
- JPRN-UMIN000032398
- Lead Sponsor
- Gunma University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To decide maximum tolerated dose of irradiation fluence (50, 75 or 100 J/cm2) to evaluate dose limited toxicity
- Secondary Outcome Measures
Name Time Method