Ramucirumab plus Irinotecan / Leucovorin / 5-FU versus Ramucirumab plus Paclitaxel in patients with advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction, who failed one prior line of palliative chemotherapy - The Phase II/III RAMIRIS STUDY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512934-14-00

Acronym

RAMIRIS

Enrollment

319

Registered

2024-11-04

Start date

2016-11-07

Completion date

Unknown

Last updated

2025-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junctions, who failed prior line of palliative chemotherpay

Brief summary

Co-primary endpoints: Overall Survival (OS) defined as the time from randomization to death from any cause and assessed according to Kaplan-Meier and Objective Overall Response Rate (ORR) defined as the proportion of patients with complete or partial remission according to RECIST 1.1

Detailed description

To compare treatment arms with respect to • Progression-free survival • Objective response rate (CR + PR) • Tumor control rate (CR, PR, SD) • Safety (according to NCI-CTCAE V 4.03) and tolerability • Assessment of quality of life during treatment and follow-up.

Interventions

DRUGIrinotecan Kabi 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUG5-FU medac 50 mg/ml

DRUGInjektionslösung

DRUGCalciumfolinat Sandoz 10 mg/ml – Injektions-/Infusionslösung

DRUGSANIFOLIN polvere per soluzione iniettabile

DRUGPaclitaxel Aurobindo 6 mg/ml concentrato per soluzione per infusione

DRUGPaclitaxel Accord 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGLeucovorin 10 mg/ml Lösung zur Injektion/ Infusion

DRUGCyramza 10 mg/ml concentrate for solution for infusion

DRUGPaclitaxel Ribosepharm 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGIrinotecan Aurobindo 20 mg/ml concentrato per soluzione per infusione

DRUGFluorouracil Accord 50 mg/ml Injektions- oder Infusionslösung

DRUGFluorouracile Teva 1 g/20 ml soluzione per infusione

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Co-primary endpoints: Overall Survival (OS) defined as the time from randomization to death from any cause and assessed according to Kaplan-Meier and Objective Overall Response Rate (ORR) defined as the proportion of patients with complete or partial remission according to RECIST 1.1	—

Secondary

Measure	Time frame
To compare treatment arms with respect to • Progression-free survival • Objective response rate (CR + PR) • Tumor control rate (CR, PR, SD) • Safety (according to NCI-CTCAE V 4.03) and tolerability • Assessment of quality of life during treatment and follow-up.	—

Countries

Austria, Germany, Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026