Table 11.
Clinical trials of HAIC + sorafenib versus sorafenib alone
| Ikeda et al. [172] | Kudo [173] | He et al. [174] | ||||
|---|---|---|---|---|---|---|
| Trial name | HCC_Sor_CDDP_rP2 | SILIUS | na | |||
| Phase | Phase 2 | Phase 3 | Phase 3 | |||
| Design | RCT | RCT | RCT | |||
| Patients | Child-Pugh class A | Child-Pugh class A/B7 | Child-Pugh class A | |||
| BCLC stage B/C | BCLC stage B/C | BCLC stage C with Vp | ||||
| Comparator | Sorafenib | Sorafenib | Sorafenib | |||
| HAIC regimen | CDDP | CDDP/5FU (low-dose FP) | Oxaliplatin/leucovorin/5FU (FOLFOX) | |||
| Patients, n | 108 | 206 | 247 | |||
| Sorafenib + HAIC | Sorafenib | Sorafenib + HAIC | Sorafenib | Sorafenib + HAIC | Sorafenib | |
|---|---|---|---|---|---|---|
| OS, months | 10.6 | 8.7 | 11.8 | 11.5 | 13.37 | 7.13 |
| HR (95% CI), p value | 0.60 (0.38–0.96), 0.031 | 1.009 (0.743–1.371), 0.955 | 0.35 (0.26–0.48), <0.001 | |||
HAIC, hepatic arterial infusion chemotherapy; RCT, randomized controlled trial; BCLC, Barcelona Clinic Liver Cancer; OS, overall survival; HR, hazard ratio; CI, confidence interval.