Gastric and Gastroesophageal Junction Cancer · Medical · Advanced / Metastatic · First-line unresectable locally advanced/recurrent/metastatic gastric/GEJ adenocarcinoma

ORIENT-16

Clinical question: In first-line unresectable locally advanced/recurrent/metastatic gastric/gej adenocarcinoma, does the investigational strategy improve clinically meaningful outcomes versus its control?

Registry: NCT03745170 · One underlying study; aliases and follow-up publications consolidated.

Phase III, randomized, double-blind, placebo-controlled trial; 650 patients in China. Evidence cut-off: 13 November 2026.

Design, population and eligibility

Design / sample size

Phase III, randomized, double-blind, placebo-controlled trial; 650 patients in China.

Eligibility

Previously untreated unresectable locally advanced, recurrent or metastatic gastric/GEJ adenocarcinoma.

Intervention

Sintilimab + CAPOX versus placebo + CAPOX.

Sintilimab 200 mg IV every 3 weeks with capecitabine/oxaliplatin for up to 6 cycles, followed by maintenance sintilimab/placebo plus capecitabine per protocol.

Comparator

placebo + CAPOX.

Primary endpoint: OS primary; CPS ≥5 and ITT co-primary populations.

Key efficacy outcomes

ITT median OS 15.2 vs 12.3 months, HR 0.77 (95% CI 0.63–0.94), p=0.009. CPS ≥5 OS 18.4 vs 12.9 months, HR 0.66 (0.50–0.86), p=0.002.

Reported outcome

15.2

Comparator: 12.3. The bars are a simple display of the first reported pair only; consult the endpoint and time horizon above.

Safety and treatment delivery

Grade ≥3 treatment-related thrombocytopenia 24.7% vs 21.3%, neutropenia 20.1% vs 18.8%, anaemia 12.5% vs 8.8%.

Clinical interpretation and limitations

Positive trial in a Chinese population; generalizability and regulatory availability vary. More than 85% discontinued study treatment by the reported cutoff. Do not assume equivalence with other PD-1 agents from cross-trial comparisons.

Interpret the reported hazard ratios in the context of the prespecified endpoint, statistical hierarchy, follow-up maturity, crossover/subsequent therapy and enrolled population. Median survival differences are not risk differences and must not be converted into NNT.

Absolute effect

No NNT/NNH is displayed unless an absolute event-risk difference at a clearly stated fixed timepoint can be calculated from reported trial data. Median survival differences and hazard ratios alone do not support an NNT. The visual above uses reported outcome data only.

Primary publication and follow-up

Primary publication

Registry / follow-up / authoritative source

Source-level verification status: primary publication identified and key quoted outcomes transcribed; where full-text toxicity or procedural details were not available, the page explicitly flags the limitation rather than inferring values.

Current-practice context · 13 November 2026

This page separates historical trial results from contemporary practice. Verify the applicable jurisdictional guideline, regulatory approval, biomarker assay, liver function, comorbidity and treatment availability before applying the evidence. NCCN Guidelines Insights are not a substitute for the full NCCN guideline.

Guideline/regulatory reconciliation and browser-rendered QA remain scheduled for the subsequent quality-control pass.