Esophageal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients must have histologically or cytologically confirmed adenocarcinoma, adenosquamous carcinoma or squamous carcinoma of the esophagus. Patients must be diagnosed to be refractory or intolerable to standerd anti-cancer drugs such as fluoropyrimidine, platinum and Taxane. KPS of 80 to 100. Patients must be HLA-A02 or HLA-A24. Life expectancy at least 3 months. Age >= 20 years. Patients must have normal organ and marrow function as defined below: white blood cells; >=2000,<=15000 platelets; >= 50000 total bilirubin; <=3.0mg/dL AST; <=150IU/L ALT; <=150IU/L Creatinine; <=2.0mg/dL The willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: Patients who received all peptides derived from VEGFR-1, VEGFR-2, URLC10 and KIF20A. Patients with other malignant tumor except for mucosal lesion. Primary tumor is widely invaded to other organs and is strongly concerned to bleed. History or intercurrent illness of intestinal pneumonia or pulmonary fibrosis. Symptomatic CNS metastasis. Patients with pleural effusion, abdominal effusion or pericardial effusion requiring a puncture or drainage. Severe infection or suspicious of severe infection. Severe mental disorder or severe neurological disorder. Uncontrolled heart, lung, kidney, or liver disease. Other uncontrolled intercurrent illness. Previous history of myocardial infarction, severe unstable angina, CABG surgery, congestive heart failure, cerebrovascular disease, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism within 12 months prior to drug administration. Uncured traumatic injury (including traumatic bone fracture). Bleeding diathesis (including the fatal aneurysm) or coagulopathy. Continuous administration of antithrombotic drugs except for aspirin. Treatment-resistant hypertension. Heart failure under treatment. Patients receiving other investigational agents. Women who are breast-feeding or pregnant. Patients without intention to contraception. Patients who are judged as ineligible to attend study by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Adverse event Efficacy: Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| immunological evaluation Progression free survival Response rate (RECISTv1.1, irRC) QOL | — |
Countries
Japan
Contacts
Wakayama medical university 2nd. department of Surgery