Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Meta… (NCT05927857) | Clinical Trial Compass
RecruitingPhase 1/2
Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .
Taiwan45 participantsStarted 2024-04-01
Plain-language 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
Who can participate
Age range20 Years – 80 Years
SexALL
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Inclusion 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 adjuvant treatment.
✓. ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1
✓. patients with HER2/neu-positive tumor must be exposure to Herceptin treatment
✓. at least one measurable disease according to the RECIST version 1.1;
✓. patients are aged 20 to 80 years;
✓. patients have a life expectancy ≥ 3 months;
✓. patients have adequate renal function with defined as serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or Ccr ≥ 40 mL/min;
Exclusion criteria
✕. patient can't take oral drugs;
✕
What they're measuring
1
To determine MTD (maximum tolerated dose) of nal-IRI (ONIVYDE)
Timeframe: Phase I last patient in has been treated for 28 days.
2
To evaluate disease objective response rate (ORR)
Timeframe: Whichever occurs first assessed up to 24 months.
Trial details
NCT IDNCT05927857
SponsorNational Health Research Institutes, Taiwan
. known hypersensitivity to irinotecan, fluoropyrimidine, or ramucirumab;
✕. receipt of surgery within the past 4 weeks before study enrollment;
✕. ≥ grade 2 diarrhea and ascites
✕. concurrent severe infection with intravenous systemic antibiotics treatment;
✕. patients have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to first dose of protocol therapy;
✕. patients have a prior history of GI perforation/fistula (within 6 months of first dose of protocol therapy) or risk factors for perforation;