Gastric and Gastroesophageal Junction Cancer · Medical · Advanced / Metastatic · Second-line previously treated advanced gastric/GEJ adenocarcinoma

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Clinical question: In second-line previously treated advanced gastric/gej adenocarcinoma, does the investigational strategy improve clinically meaningful outcomes versus its control?

Registry: NCT01170663 · One underlying study; aliases and follow-up publications consolidated.

Phase III, double-blind, placebo-controlled RCT; 665 patients. Evidence cut-off: 13 November 2026.

Design, population and eligibility

Design / sample size

Phase III, double-blind, placebo-controlled RCT; 665 patients.

Eligibility

Advanced gastric/GEJ adenocarcinoma progressing on or within 4 months after first-line platinum/fluoropyrimidine chemotherapy.

Intervention

Ramucirumab + paclitaxel versus placebo + paclitaxel.

Ramucirumab 8 mg/kg IV days 1 and 15 plus paclitaxel 80 mg/m² IV days 1, 8 and 15 of a 28-day cycle.

Comparator

placebo + paclitaxel.

Primary endpoint: OS primary; PFS and response secondary.

Key efficacy outcomes

Median OS 9.6 vs 7.4 months, HR 0.807 (95% CI 0.678–0.962), p=0.017.

Reported outcome

9.6

Comparator: 7.4. 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 neutropenia 41% vs 19%, leukopenia 17% vs 7%, hypertension 14% vs 2%, fatigue 12% vs 5%; febrile neutropenia 3% vs 2%.

Clinical interpretation and limitations

Positive second-line combination evidence. Consider performance status, neuropathy, marrow reserve, bleeding/thrombotic risk and hypertension. Not a comparison against modern immunotherapy/targeted sequences.

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.