Table 1 Fragility index calculated for 6 phase 3 trials with 1:1 randomization for HCC treatment
From: Frequent fragility of randomized controlled trials for HCC treatment
Author | Study name | Clinical Trial | Experimental Treatment vs. Control | Endpoint | Experimental sample size | Experimental event number | Control sample size | Control event number | P vaule | Fragility index | Fragility quotient |
|---|---|---|---|---|---|---|---|---|---|---|---|
Kudo M et al. [4]. | SILIUS | NCT01214343 | Sorafenib plus HAIC (hepatic arterial infusion chemotherapy) vs. Sorafenib | Primary outcome: Overall response | 102 | 37 | 103 | 18 | 0.003 | 7 | 3.41% |
Wang Z et al. [6]. | NA | NCT01966133 | adjuvant TACE vs. No adjuvant TACE | Primary endpoint: Recurrence-free survival | 140 | 46 | 140 | 82 | 0.01 | 19 | 6.79% |
Lee JH et al. [7]. | NA | NCT00699816 | CIK cell agent vs. No CIK cell agent | Primary end point: Recurrence-free survival | 114 | 69 | 112 | 59 | 0.01 | 0 | 0% |
Llovet JM et al. [8]. | SHARP | NCT00105443 | Sorafenib vs. Placebo | Primary endpoint: Overall survival | 299 | 44 | 303 | 33 | 0.00583 | 0 | 0% |
Wei W et al. [9]. | NA | NCT02788526 | Hepatectomy plus TACE vs. Hepatectomy | Primary endpoint: Disease-free survival | 116 | 83 | 118 | 85 | 0.02 | 0 | 0% |
Geissler EK et al. [10]. | NA | NCT0035586. | Liver transplantation with sirolimus vs. Liver transplantation | Secondary endpoint: Overall survival | 252 | 242 | 256 | 234 | 1 | 0.20% |