4.4. Endpoints
tumor, DLTs
SECONDARY, METASTASIS, TUMOR
The incidence of AEs and serious AEs, including DLTs, was the primary endpoint. The secondary endpoints were one-year OS, progression-free survival, and the distant metastasis rate. In addition, as secondary endpoints, the OR and CR rates were assessed. Furthermore, tumor tissue and blood were collected before and one week after treatment began. These samples were evaluated as an exploratory goal to assess the relationship between immune response and prognosis.This paper focuses on the early results for safety and efficacy; thus, it reports the AEs and response rates.