Dr Takahiro KINOSHITA National Cancer Center Hospital East Japan Link to biosketch

Abstract

In this presentation, the current situation of clinical trials relevant with gastric cancer surgical treatment is summarized from the viewpoints in Japan.

MIS: Recently, the final analyses of JLSSG0901 (RCT: open DG vs lap DG for cStageII/III) has been disclosed, which clearly confirmed non-inferiority of lap DG to open DG in the primary endpoint (RFS). Accordingly, lap DG for cStage II/III has become a standard treatment but surgery should be managed by well-experienced surgeons. Regarding lap TG for cStage II/III, robust evidence of survival outcomes is still lacking. JCOG1809 (phase-II) is ongoing to evaluate safety and efficacy of lap/robotic spleen-preserving splenic hilar dissection. Robotic surgery is penetrating society across Japan, and JCOG1907 (RCT: lap vs robotic for cStage I/II) is ongoing to prove superiority of robotic gastrectomy in surgical outcomes.

Surgical procedure: JCOG1711 (RCT: total omentectomy vs omentum-preserving for cT3-4) is ongoing (recruiting phase).

Perioperative chemotherapy: In Japan, NAC is still limited to cases with extensive LN metastasis (Bulky LN meta/paraaortic a2-b1 LN meta). JCOG1509 (RCT: upfront surgery vs NAC) is ongoing to evaluate efficacy of NAC for cStage III cases (cT3-4N(+)). Regrettably, JCOG1301C (RCT: NAC-SP vs NAC-SP+Tmab for HER2(+) cN(+) cancer) has stopped due to unsatisfactory recruiting. Instead, now EPOC2003 (multi-center phase-II) is ongoing to evaluate safety and efficacy of NAC using trastuzumab deruxtecan (T-DXd) for HER2(+) cStageII/III cases (primary endpoint: major pathological response). NAC using ICI is also promising regimen. We participate in several global RCTs (KN-585: NAC with Pembrolizumab, following-phase) (Matterhorn: NAC with Durvalumab, recruiting phase). In NCCHE, EPOC2001 (single-center phase-II) is ongoing to evaluate safety and efficacy of NAC using lenvatinib with pembrolizumab (primary endpoint: major pathological response).