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

Recruiting Phase 1 Phase 2 Interventional Study
Metastatic Gastric Adenocarcinoma Second Line Chemotherapy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
20 – 80
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
National Health Research Institutes, Taiwan · Other
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About This Trial
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 eval…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. histologically or cytologically confirmed metastatic gastric adenocarcinoma 2. patients have received only first line of systemic therapy, including recurrence during adjuvant therapy or within 6 months after the completion of adjuvant treatment. 3. ECOG(Eastern Cooperative O…
Contacts

Chien-Ya Hung, BS

+886-3-7206166

951106@nhri.edu.tw

CONTACT

Nai-Jung Chiang, MD-PhD

+886-9-58925290

njchiang@nhri.edu.tw

CONTACT