Advanced or recurrent esophageal cancer
Conditions
Interventions
Docetaxel 50 mg/m2/day day1 Dendritic cell day15,22 q4w , 3 cycle
Sponsors
School of Medicine, Keio University
Tokyo Midtown Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Primary lesion is located at cervical or thoracic or abdominal esophagus 2)Histological diagnosis of esophageal cancer(adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma) 3)Patients with progressive disease treated by 5FU and cisplatin 4)Possess HLA-A2402 5)Obtains lesion that can be evaluated by RECIST 6)performance status (ECOG) 0,1,2 7) Adequate hematologic, hepatic, renal, and cardiac function a)WBC >=3,000/mm3 b)Absolute neutrophil count 1,500/mm3 c)Platelet >=100,000/mm3 d)Hemoglobin >=9.0g/dL e)AST and ALT <=100IU/L f)Total bilirubin <1.5mg/dL g)Creatinine <1.5mg/dL h)ECG normal 8)Four weeks or more must pass from the prior treatment 9)Written informed consent Edit 10)Previously treated-patient with 5-FU, cisplatin and/or docetaxel and/or radiotherapy.
Exclusion criteria
Exclusion criteria: 1)Tracheo-esophageal fistula 2)Symptomatic brain metastasis 3)Active other primary malignancies 4)Past history of severe allergy 5)Severe comorbidity (infections, interstitial pneumonia, fibroid lung, cardiovascular disease, renal disease, liver disease, uncontrolled diabetes) 6)Pleural effusion or pericardial fluid requiring treatment 7)Pregnancy, nursing women 8)Male hope to impregnate 9)Severe psychiatric disease 10)Active autoimmune disease 11)During treatment with immunosuppressive agents 12)Patients whom doctors judged inadequate to the enrollment of this study by other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Advertise events | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Progression free survival Overall survival Immune induction (Delayed type hypersensensitivity DTH for WT1 peptide) | — |
Countries
Japan
Outcome results
None listed