Esophageal squamous cell carcinoma
Conditions
Interventions
S-488410 (1 mg each of S-488401, S-488402, and S-488403) is subcutaneously administered weekly to the neck, armpit, or groin of the patients.
S-488410 (2 mg each of S-488401, S-488402, and S-488403) i
Sponsors
Shionogi & Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting all of the following criteria will be included: 1)Patients with advanced or recurrent esophageal carcinoma 2)Patients who do not respond to standard chemotherapy (treatment including a fluorinated pyrimidine anticancer drug, platinum-containing drug, taxane anticancer drug) or are unable to continue treatment due to an adverse drug reaction 3)Patients who were histologically diagnosed as squamous cell carcinoma 4)Patients with a primary tumor or metastasis confirmed by imaging within 4 weeks before enrollment 5)Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 within 2 weeks before enrollment 6)Patients expected to have life prognosis at least 3 months after enrollment
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded: 1)Patients with multiple primary cancer (other than a non-melanoma skin cancer or cervical epithelial cancer) 2)Patients currently receiving or scheduled to receive during the study any antineoplastic agent, immunosuppressant, adrenocortical steroid, radiation therapy, immunotherapy, heat therapy, or surgery 3)Patients with substantial tumor invasion in the trachea 4)Patients with an autoimmune disease 5)Patients positive for anti-HIV antibody or antigen within 2 weeks before enrollment 6)Patients whose prior therapy for the primary disease has not concluded (final day of drug or radiation treatment) within 4 weeks before enrollment 7)Patients with a marrow function, hepatic function, or renal function test value meeting any of the following criteria in laboratory tests performed within 2 weeks before enrollment - White blood cell count: < 2000/mm3 or > 15000/mm3 - Platelet count: < 50000/mm3 - AST and ALT: > 5-fold the upper limit of the standard range of the study center - Total bilirubin: > 3-fold the upper limit of the standard range of the study center - Serum creatinine: > 3-fold the upper limit of the standard range of the study center 8)Patients who are pregnant, may be pregnant, or are lactating woman 9)Patients who are unable or do not wish to engage in appropriate contraception from the time of enrollment to 12 weeks after the completion of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I Term, severity, and incidence of adverse events and adverse drug reactions Phase II The rate of Cytotoxic T lymphocyte (CTL) induction | — |
Countries
Japan
Outcome results
None listed