Table 1.

Significant clinical trials presented at the Gastrointestinal Cancers Symposium 2015 investigating novel agents in gastric, liver, and colorectal carcinomas

Authors	Phase	Treatment line	Design	Primary end point	Trial outcome
Kwak et al7	I	Refractory	AMG 337, single arm	Safety	Good tolerance, RR: 62%
Shah et al8	II, randomized	First-line	FOLFOX ± onartuzumab	PFS	HR
Zhu et al22	III, randomized	Second-line	Ramucirumab vs placebo	OS	HR: 0.67; (95% CI: 0.51–0.90*; P=0.0059)
Cheng et al24	II, randomized	First-line	Dovitinib vs sorafenib	OS	HR: 1.27; 95% CI: 0.89–1.80; P=ns
Palmer et al25	II, randomized	First-line	Nintedanib vs sorafenib	TTP	HR: 1.05; 95% CI: 0.63–1.76; P=ns
Tabernero et al34	III, randomized	Second-line	FOLFIRI + ramucirumab vs FOLFIRI + placebo	OS	HR: 0.84; (95% CI: 0.73, 0.98); P=0.0219
Xu et al35	II, randomized	Refractory	Famitinib vs placebo	PFS	HR: 0.58; P=0.0034

Notes:

^*A prespecified subgroup analysis according to baseline alpha-fetoprotein (AFP) level suggested that patients with baseline AFP ≥400 ng/mL might derive benefit from ramucirumab treatment vs placebo (OS HR: 0.67, 95% CI: 0.51–0.90; P=0.0059).

Abbreviations: CI, confidence interval; HR, hazard ratio; ns, nonsignificant; OS, median overall survival; PFS, progression-free survival; RR, response rate; TTP, time to progression.