Stomach Cancer
ICD-10 C16 · ICD-11 2B72

Treatment of HER2-Negative Locally Advanced Unresectable or Metastatic Gastric Cancer

Clinical Scenario

This protocol covers patients with gastric cancer that is either locally advanced and unresectable, or has spread to distant sites, and in whom tumour testing has confirmed HER2-negative status. This biomarker distinction is central to treatment selection across all lines of therapy.

Biomarker Context
HER2-negative

In HER2-negative disease, PD-L1 expression guides first-line decisions: an anti-PD-1 antibody combined with fluoropyrimidine/platinum-based chemotherapy is an established palliative first-line approach for patients with PD-L1-positive tumours. Microsatellite instability (MSI-H/dMMR) status is an additional biomarker that bears on treatment selection in later lines.

Second-Line Treatment Approach

Palliative second-line systemic therapy for this population includes an antiangiogenic-based combination as the preferred regimen, alongside further options that depend on tumour biomarker profile.

The complete evidence-based regimen — preferred agents, alternatives, and biomarker-driven pathways — is set out in the full protocol below.

Instant Access to Structured Evidence-Based Regimens
References

DOI: 10.5230/jgc.2025.25.e11

Palliative first-line systemic therapy with anti-PD-1 antibody combined with fluoropyrimidine/platinum-based chemotherapy is recommended in patients with HER2-negative and PD-L1-positive locally advanced unresectable or metastatic gastric cancer.

Palliative second-line systemic therapy with ramucirumab combined with paclitaxel is recommended in patients with locally advanced unresectable or metastatic gastric cancer; however, other agents may also be considered.

Other agents, including irinotecan, docetaxel, paclitaxel can also be considered second-line options if not previously administered in the first-line treatment.

In Korea, pembrolizumab was approved in patients with several inoperable or metastatic solid tumors, including gastric cancer with MSI-H or dMMR, who have progressed following prior treatment and who have no satisfactory alternative treatment options.

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