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

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion date: Dec 31, 2026 to Dec 31, 2027
    • Study completion date: Dec 31, 2027 to Dec 31, 2028
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Aug 31, 2025 to Dec 31, 2026
    • Start date changed from estimate of Sep 1, 2023 to Apr 1, 2024
    • Study sites: 0 to 1
    • Study completion date: Dec 31, 2025 to Dec 31, 2027
    • Eligibility criteria expanded, about 2 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
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
(from sponsor)		 Metastatic Gastric Adenocarcinoma, Second Line, Chemotherapy
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov