Gastric and Gastroesophageal Junction Cancer · Medical · Advanced / Metastatic · Second-line monotherapy after progression on first-line chemotherapy

REGARD

Clinical question: In second-line monotherapy after progression on first-line chemotherapy, does the investigational strategy improve clinically meaningful outcomes versus its control?

Registry: NCT00917384 · One underlying study; aliases and follow-up publications consolidated.

Phase III, international, randomized, double-blind, placebo-controlled trial; 355 patients. Evidence cut-off: 13 November 2026.

Design, population and eligibility

Design / sample size

Phase III, international, randomized, double-blind, placebo-controlled trial; 355 patients.

Eligibility

Advanced gastric/GEJ adenocarcinoma progressing after first-line platinum/fluoropyrimidine-based chemotherapy.

Intervention

Ramucirumab monotherapy plus best supportive care versus placebo plus best supportive care.

Ramucirumab 8 mg/kg IV every 2 weeks.

Comparator

placebo plus best supportive care.

Primary endpoint: OS primary.

Key efficacy outcomes

Median OS 5.2 vs 3.8 months, HR 0.776 (95% CI 0.603–0.998), p=0.047.

Reported outcome

5.2

Comparator: 3.8. The bars are a simple display of the first reported pair only; consult the endpoint and time horizon above.

Safety and treatment delivery

Hypertension 16% vs 8%; grade ≥3 hypertension was uncommon; drug-related deaths approximately 2% in each arm.

Clinical interpretation and limitations

Modest but statistically positive survival benefit for anti-VEGFR2 monotherapy in second-line disease. Absolute median OS gain is 1.4 months; the trial predates current biomarker-selected and immunotherapy sequencing.

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.