Actively Recruiting
Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .
Led by National Health Research Institutes, Taiwan · Updated on 2026-04-09
45
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
N
National Health Research Institutes, Taiwan
Lead Sponsor
T
Taipei Veterans General Hospital, Taiwan
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic gastric adenocarcinoma
- Received only first line of systemic therapy, including recurrence during or within 6 months after adjuvant therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Exposure to Herceptin treatment if tumor is HER2/neu-positive
- At least one measurable disease per RECIST version 1.1
- Aged between 20 and 80 years
- Life expectancy of 3 months or more
- Adequate kidney function with serum creatinine 1.5 times upper limit of normal (ULN) or creatinine clearance 40 mL/min
- Adequate liver function with total bilirubin 1.5 times ULN and AST and ALT 3 times ULN or 5 times ULN if liver metastases present
- Adequate bone marrow function with neutrophils 1500/mm3, hemoglobin 9 g/dL, and platelets 100,000/mm3; transfusions or G-CSF support allowed
- International Normalized Ratio (INR) 1.5 and partial thromboplastin time (PTT/aPTT) 1.5 times ULN
- Urinary protein 1+ on dipstick or less than 1000 mg protein in 24-hour urine if dipstick 2+
- Effective contraception for patients with childbearing potential and their partners during the study
- Female patients of childbearing potential must have a negative pregnancy test within 7 days prior to first treatment
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Unable to take oral medications
- Known allergy to irinotecan, fluoropyrimidine, or ramucirumab
- Surgery within 4 weeks before study enrollment
- Grade 2 or higher diarrhea or ascites
- Severe infection requiring intravenous antibiotics
- Arterial thromboembolic events within 6 months prior to first treatment
- History of gastrointestinal perforation or fistula within 6 months or risk factors for perforation
- Cirrhosis at Child-Pugh B level or worse, or cirrhosis with hepatic encephalopathy or significant ascites
- Serious or nonhealing wounds, ulcers, or bone fractures within 28 days before treatment
- Major surgery within 28 days or minor surgery/venous access device placement within 7 days before treatment
- Uncontrolled high blood pressure (>160/100 mmHg) for more than 4 weeks despite treatment
- Grade 3-4 gastrointestinal bleeding within 3 months before treatment
- Deep vein thrombosis, pulmonary embolism, or significant thromboembolism within 3 months before treatment
- Chronic use of antiplatelet therapy except once-daily aspirin (up to 325 mg/day)
- Prior treatment with nal-IRI (ONIVYDE), TAS-102 (LONSURF), or ramucirumab
- Another cancer diagnosed within the past 5 years except non-melanoma skin cancer or stage I cervical cancer
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Taipei Veterans General Hospital
Taipei, Taiwan/Taipei, Taiwan
Actively Recruiting
Research Team
C
Chien-Ya Hung, BS
CONTACT
N
Nai-Jung Chiang, MD-PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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