Clinical Trial

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

Recruiting Phase 1/2
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Summary
Primary Objectives * In phase 1b cohort, to determine MTD (maximum tolerated dose) of nal-IRI (ONIVYDE®) in combination with Ramucirumab (Cyramza®) and TAS-102 (LONSURF®) * In phase II cohort, to evaluate disease objective response rate (ORR) of Ramucirumab (Cyramza®), nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®) Secondary Objectives * To evaluate disease control rate (DCR) * To evaluate progression-free survival (PFS) * To evaluate overall survival (OS) * To assess the safety profile * To study the blood biomarkers
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-06-25; most recent amendment 2026-04-06.
Status change: Not Yet Recruiting → Recruiting 2025-08-18
Trial Details
NCT Number NCT05927857
Lead Sponsor National Health Research Institutes, Taiwan
Collaborators: Taipei Veterans General Hospital, Taiwan, China Medical University Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Chang Gung Memorial Hospital
Conditions Metastatic Gastric Adenocarcinoma, Second Line, Chemotherapy
Enrollment 45 participants
Start Date 2024-04-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-09