Esophageal cancer
Conditions
Interventions
Hyperthermia EHY2000
Sponsors
Chiba University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Recurrent esophageal cancer progression which has been demonstrated to be a squamous cell carcinoma tissue type. (2) Prolongation of survival cannot be expected by conventional surgery, chemotherapy, radiation therapy which are covered by health insurance. (3) Measurable lesion according to RECIST ver 1.1 is found at least one. (4) Age at the time of obtaining informed consent should be over 20 years old and less than 80 years, irrespective of gender. (5) Performance Status (ECOG) should be 0 or 1. (6) In the time of registration 4 weeks should have elapsed since when the prior treatment (surgery, chemotherapy or radiation therapy) was done. (7) Prognosis is expected to be more than two months from the date of registration. (8) Bone marrow, liver and renal function should have the following measured data within 14 days prior to registration. 1) hemoglobin: More than 8.0g/dL 2) white blood cell count: Less than 2,000 ~ 12,000/mm3 3) platelet count: More than 7x104/mm3 4) total bilirubin: Less than 1.5 mg/dL 5) AST (GOT); ALT (GPT): less than 100 U/L 6) serum creatinine: Below the upper limit of the reference values 7) O2Sat: More than 92% ** Even if the value of AST (GOT), ALT of (GPT) does not meet the above conditions, it is caused by the underlying disease is left to the discretion of the physician investigator or trial division has priority if it be judged to be caused by the underlying disease. (9) Consent in writing has been obtained from patients for participation in this study.
Exclusion criteria
Exclusion criteria: (1) patients having history of hyperthermia therapy. (2) Patients with esophageal primary tumor forming a fistula. (3) Patients admitted fever with obvious infection (over 38.5 degree) (4) Seriously malnutrition (5) With pleural effusion, ascites, and pericardial which requires control (6) Heart disease (requiring hospitalization) or severe cases with a history (7) Other complications cases that require hospitalization (intestinal paralysis, intestinal obstruction, pulmonary fibrosis, diabetes control is difficult, renal failure, or cirrhosis of the liver, such as interstitial pneumonia) (8) (Patients with mental disorders are thought to require treatment or during treatment with antipsychotic drugs. (9) At the time of registration those who has cancers concurrency or has a metachronous cancers with disease-free interval less than 5 years (carcinoma in situ lesions and carcinoma in situ that are considered cured by local treatment is not included) (10) The oral or injectable steroids is under use (11) Antigen HBs, antibody HCV, HTLV-1 antibody-positive or have a history of hepatitis or HIV antibodies. (12) With a history of hypersensitivity to albumin. (13) Women with (making) the possibility of pregnancy and pregnant or lactating women. (14) Men who have intention to make pregnant. (15) Patients with autoimmune disease. (16) Cases the physician (sharing) was deemed inappropriate as the subject of the study investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Evaluation of safety and dverse reactions Phase II: Immune response and anti-tumor effects | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: QOL Phase II: QOL, OS, PFS | — |
Countries
Japan
Contacts
Public ContactYasunori Akutsu
Chiba University Department of Frontier Surgery
Outcome results
None listed