malignant tumor
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: A patient MUST: 1) Be diagnosed with relapsed or advanced malignant tumor. 2) Have a measurable lesion of tumor. 3) Have an Eastern Cooperative Oncology Group performance-status score of 0 or 1. 4) Be administered immune check point inhibitor and immune-cell therapy within 4 weeks at the clinic. 5) Have an adequate function of liver, kidney, and bone marrow when the eligibility is confirmed. 6) Provide agreement of the attending doctor to participate in this study. 7) Have a backup hospital in the case of emergency. 8) Provide written consent to participate in this study.
Exclusion criteria
Exclusion criteria: A patient MUST NOT: 1) Have a positive result of HIV antibody. 2) Have a T cell-, NK cell-derived malingnant lymphoma/leukemia (in the case of activated immune-cell therapy). 3) Be post allogenic bone marrow transplantation. 4) Have a history of a serious adverse event due to immune check point inhibitor. 5) Be a female who is pregnant, lactating, or with a possibility of pregnancy. 6) A patient who is judged as inadequate for enrolment by doctors is excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Immunological response | — |
Countries
Japan
Contacts
Koshikai, Non-profit Medical Corporation