NCT03081143

Ramucirumab Plus FOLFIRI Versus Ramucirumab Plus Paclitaxel in Patients With Advanced or Metastatic Gastric Cancer, Who Failed One Prior Line of Palliative Chemotherapy

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 429 (actual)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will evaluate whether it is beneficial in terms of prolongation of survival to combine FOLFIRI (standard treatment) with ramucirumab compared to the standard treatment of ramucirumab plus paclitaxel in patients with advanced gastric cancer after failure of one prior line of palliative chemotherapy. This trial aims to investigate the efficacy and safety of ramucirumab plus FOLFIRI (investigational arm A) compared to paclitaxel plus ramucirumab (control arm B).

Conditions

• Advanced Gastric or EGJ Cancer

Interventions

Type	Name	Description
DRUG	FOLFIRI	Irinotecan 180 mg/m2; i.v. bolus of 5-FU 400 mg/m2, i.v. infusion of leucovorin\* 400 mg/m2 , followed by a 46-hour continuous administration of 5-FU 2400 mg/m2 on day 1 and 15 of a 28-day cycle
DRUG	Ramucirumab	8 mg/kg i.v. infusion on day 1 and 15 of a 28-day cycle
DRUG	Paclitaxel	80 mg/m2 on day 1, 8, 15

Timeline

• Start date: 2017-05-10
• Primary completion: 2026-05-01
• Completion: 2026-12-01
• First posted: 2017-03-16
• Last updated: 2026-04-14

Locations

16 sites across 3 countries: Austria, Germany, Italy