Table 1.
Primary objectives
Primary objective | Definition of objectives | Timepoint of objectives evaluation |
---|---|---|
Assessment of the safety of intratumoral phIL12 GET | Assessment of adverse events in accordance with the CTCAE v5 criteria | From the beginning of therapy until the follow-up examination on day 30 after the treatment (day 1, 3, 8 and 31) |
Assessment of the tolerability of intratumoral phIL12 GET | Assessment by the quality of patient of life questionnaire reported outcome EORTC QLQ-C30 | A follow-up examination on day 0, 8 and 31 |
CTCAE = Common Terminology Criteria for Adverse Events; GET = gene electrotransfer