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

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).

Timeline

Start

2017-05-10

Primary completion

2026-05-04

Completion

2026-05-04

Outcome

Missed primary endpoint

paper The study did not meet the primary end-point for the comparison with historical control PMID 35202974 ↗

Publications

• Results Lorenzen S, Thuss-Patience P, Pauligk C, Gokkurt E, Ettrich T, Lordick F, Stahl M, Reichardt P, Sokler M, Pink D, Probst S, Hinke A, Goetze TO, Al-Batran SE. FOLFIRI plus ramucirumab versus paclitaxel plus ramucirumab as second-line therapy for patients with advanced or metastatic gastroesophageal adenocarcinoma with or without prior docetaxel - results from the phase II RAMIRIS Study of the German Gastric Cancer Study Group at AIO. Eur J Cancer. 2022 Apr;165:48-57. doi: 10.1016/j.ejca.2022.01.015. Epub 2022 Feb 21.
• Lorenzen S, Schwarz A, Pauligk C, Goekkurt E, Stocker G, Knorrenschild JR, Illerhaus G, Dechow T, Moehler M, Moulin JC, Pink D, Stahl M, Schaaf M, Goetze TO, Al-Batran SE. 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 (AIO-STO-0415). BMC Cancer. 2023 Jun 19;23(1):561. doi: 10.1186/s12885-023-11004-z.

Drugs

Indications