Durvalumab Plus Tremelimumab in Real-World HCC: JGH | May 2026

Introduction:

The HIMALAYA trial established durvalumab plus tremelimumab (STRIDE) as a first-line treatment for unresectable hepatocellular carcinoma (HCC). However, many real-world patients do not meet the strict eligibility criteria of clinical trials. This multicenter study evaluated the effectiveness and safety of STRIDE in routine clinical practice.

Why was this study needed?

• Many patients treated in routine practice would not have qualified for the HIMALAYA trial.
• Real-world effectiveness of STRIDE outside trial criteria remains uncertain.
• Better predictors of treatment outcomes are needed.
• Liver function may be more important than trial eligibility alone.
• Real-world data are essential to guide everyday clinical decision-making.

Results:

• Patients meeting the HIMALAYA eligibility criteria achieved longer progression-free and overall survival than those who did not meet trial criteria.
• Among patients outside the HIMALAYA criteria, those with preserved liver function (ALBI Grade 1) achieved survival outcomes comparable to trial-eligible patients.
• Poor liver function (ALBI ≥2), impaired performance status, and portal vein invasion were associated with worse clinical outcomes, emphasizing the importance of careful patient selection.

Clinical Impact:

This real-world study demonstrates that STRIDE remains effective beyond the strict HIMALAYA trial population, particularly in patients with well-preserved liver function. ALBI grade may be a more practical tool than trial eligibility alone when selecting patients for immunotherapy.

Bottom Line:

Preserved liver function—not simply trial eligibility—is the key determinant of successful STRIDE therapy. Patients with ALBI Grade 1 may derive meaningful benefit from durvalumab plus tremelimumab even if they would not have met the original HIMALAYA trial inclusion criteria.