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Initial results of the NRG Oncology NRG-GI003 clinical study comparing proton and photon therapy for patients with advanced hepatocellular carcinoma (HCC) indicate that proton therapy did not improve the primary objective of overall survival (OS). At the planned interim analysis, the trial was released for reporting after it crossed the futility boundary. Proton therapy also did not improve the trial's secondary endpoints, including progression-free survival (PFS) and local progression (LP).

Although fewer grade 3 or higher treatment-related adverse events were observed with proton therapy than with photon therapy (11% vs. 24%), the difference was not statistically significant at alpha=0.05 (p=0.093). The results were presented during the plenary session of the 2026 American Society for Radiation Oncology annual meeting in Boston.

"Although these findings were not positive, NRG-GI003 will help us shape the future of research surrounding this disease. The data from this trial shift our focus to identifying potential subgroups of patients with HCC who may be more likely to derive benefit from proton therapy. Additionally, outside of survival benefit, future studies should aim to determine whether protons improve quality of life or reduce side effects when compared to traditional photon therapy," stated Theodore S. Hong, MD, of the Dana-Farber Cancer Center at Harvard and lead author of the NRG-GI003 manuscript.

The Phase III trial enrolled 115 eligible patients and stratified them by planned number of treatment fractions (5 or 15 fractions) and presence of tumor vascular thrombosis.

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