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

NCT03081143 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 429

Last updated 2026-04-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Salah-Eddin Al-Batran, Prof · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-10
Primary Completion
2026-05-31
Completion
2026-12-31

Countries

  • Austria
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03081143 on ClinicalTrials.gov