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

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 ID
NCT05927857
Phase
PHASE1 / PHASE2
Sponsor
National Health Research Institutes, Taiwan
Status
RECRUITING
Cancer Type
Gastric Cancer
Interventions
  • nal-IRI /Experimental
  • Ramucirumab /Experimental
  • Trifluridine/Tipiracil /Experimental
Locations (sample)
  • Taipei, Taiwan/Taipei, Taiwan|25.05306,121.52639

Key Eligibility Criteria

  • histologically or cytologically confirmed metastatic gastric adenocarcinoma
  • patients have received only first line of systemic therapy, including recurrence during adjuvant therapy or within 6 months after the completion of…
  • ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1
  • patients with HER2/neu-positive tumor must be exposure to Herceptin treatment

For full eligibility, visit ClinicalTrials.gov.

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