STELLAR-303 was open-label and required ECOG performance status 0–1. Its protocol excluded prior regorafenib, trifluridine/tipiracil, and PD-1/PD-L1-targeting checkpoint inhibitors, limiting direct applicability to participants already exposed to these treatments. The earlier published protocol described a different endpoint hierarchy from the dual-primary-endpoint framework reported with the pivotal results, so its statistical plan should not be treated as the final analysis plan. The reported progression-free-survival difference was qualified by hierarchical testing, and the later final overall-survival analysis without active liver metastases was not statistically significant. The randomized comparison evaluates the combination against regorafenib, not the independent contribution of each combination component.