esophageal cancers esophageal cancers
Conditions
Interventions
Photodynamic therapy (PDT) is performed. Nivolumab (3 mg/kg) is started within 14 dyas after the PDT. Nivolumab is administrated intravenously every 2 weeks.
Sponsors
TANAKA MAMORU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) age > 20 years old 2) failure after chemoradiotherapy esophageal cancer 3) one week or longer from the last treatment for esophageal cancer 4) histologically proven esophageal cancer 5) at least 1 measurable or non-measurable lesion per the RECIST Guideline 6) no invasion to the cervical esophagus 7) Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-2 8) adequate organ functions (white blood cell counts >2000 /mm3, neutrophils >1000 /mm3, hemoglobin >8.0g/dL, platelet count >75000/ mm3, serum total bilirubin level <3.0 mg/dL, both alanine transferase and aspartate aminotransferase <100IU/L, Creatinine <2.0mg/dL) 9) provision of written informed consent
Exclusion criteria
Exclusion criteria: 1) significant diseases uncontrolled hypertension uncontrolled diabetes mellitus severe liver cirrhosis significant cardiovascular diseases (myocardial infarction, unstable angina, congestive heart failure) severe renal disorder 2) a current or past history of interstitial lung disease or pulmonary fibrosis 3) systemic infection requiring antibiotics 4) inability to comply the sun shade restrictions 5) baseline lesions before CRT that were judged to involve the aorta 6) porphyria 7) preexisting condition of sun photosensitivity 8) for women, pregnancy or lactation 9) unwillingness to use contraception 10) severe bleeding or shock status 11) bleeding tendency 12) current participation or prior participation within 3 months in other clinical trials for unapproved and off-label drugs or medical devices 13) patients who judged by the investigator that enrollment was inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall survival; OS 2) best overall response; BOR 3) overall response rate; ORR 4) time to response; TTR 5) duration of response; DOR 6) disease control rate; DCR | — |
Contacts
Public ContactMAMORU TANAKA
Nagoya City University Hospital
Outcome results
None listed