Outcomes
TTD, Cancer
SECONDARY, CANCER
The primary objective was to determine the ORR according to RECIST v1.1, which was defined as the percentage of participants experiencing either a CR or PR. Secondary outcomes encompassed ORR as determined by mRECIST, DCR, TTR, DoR, PFS, liver-specific PFS, OS, along with 6-month and 12-month PFS and OS rates. A comprehensive definition of these secondary endpoints is provided in the study protocol. An exploratory objective of this study was to evaluate the QoL, gauged using the European Organization for Research and Treatment of Cancer QoL questionnaire (EORTC QLQ-C30) [30]. This assessment was conducted at the study’s onset and then every 6 weeks until the treatment concluded. Scores from the EORTC QLQ-C30 were converted to a scale ranging from 0 to 100. On this scale, a higher score indicates improved functioning but increased symptom severity. The TTD in QoL was determined as treatment initiation to the first observed decline of 10 or more points from the baseline score.