Phase IbII Study of Ramucirumab, Nal-IRI, and TrifluridineTipiracil for Second-Line Treatment of Metastatic Gastric Cancer

What this Trial Is About

Researchers are studying metastatic gastric adenocarcinoma patients who have previously received only one line of systemic therapy. This trial aims to find the maximum tolerated dose MTD of the drug nal-IRI ONIVYDE combined with Ramucirumab Cyramza and TAS-102 LONSURF in a phase 1b group, and then evaluate how well this combination works in a phase II group by measuring the diseases objective response rate. Additional goals include assessing disease control, progression-free survival, overall survival, safety, and blood biomarkers. Participants will receive treatment cycles every 14 days. Each cycle includes an infusion of nal-IRI at varying doses over 90 minutes and Ramucirumab over 60 minutes on day 1, plus oral TAS-102 taken twice daily from day 1 to day 5. Dose levels range from 50 to 70 mgm2 for nal-IRI, with adjustments based on patient tolerance during the phase 1b dose escalation. Treatment continues until the disease progresses, unacceptable side effects occur, or other criteria to stop the study are met. During the study, patients undergo regular assessments including tumor scans with CT or MRI and blood tests to monitor response and safety. Clinical outcomes such as disease control, progression-free survival, overall survival, and treatment side effects will be followed for up to 24 months. Blood biomarkers will also be studied starting from baseline. The study is expected to last until the end of 2028, with close monitoring throughout.

Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .