Table 1.
Item | Study period | |||
---|---|---|---|---|
Enrollment | Allocation | Post-allocation | Close-out | |
Time point (week) | −4–0 | 0 | 1–12 | 12–24 |
Enrolment | ||||
Eligibility screen | ||||
Informed consent | × | |||
Inclusion/exclusion | × | |||
Randomization | × | |||
Allocation | × | |||
Intervention | ||||
BTG plus standard treatment | × | |||
Standard treatment | × | |||
Assessment | ||||
PFS | × | × | ||
Quality of life scores | × | × | ||
Overall survival | × | × | ||
Objective response rate | × | × | ||
Liver-specific PFS | × | × | ||
Disease control rate | × | × | ||
TCM syndrome score | × | × | ||
Piper Fatigue Scale | × | × | ||
KPS | × | × | ||
Adverse events | × | × | ||
Compliance evaluation | × | |||
Acceptability evaluation | × |
BTG, Buzhong Tiaogan granule; TCM, Traditional Chinese Medicine; KPS, Karnofsky performance score; PFS, Progression-free survival.