Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Li
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 (LO
| Condition(s) | Metastatic Gastric Adenocarcinoma, Second Line, Chemotherapy |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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 | 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 Oncology Group) performance status 0 or 1 4. patients with HER2/neu-positive tumor must be exposure to Herceptin treatment 5. at least one measurable disease according to the RECIST version 1.1; 6. patients are aged 20 to 80 years; 7. patients have a life expectancy ≥ 3 months; 8. patients have adequate renal function with defined as serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or Ccr ≥ 40 mL/min; 9. patients with adequate hepatic function as defined by a total bilirubin ≤1.5 times |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Lead sponsor | National Health Research Institutes, Taiwan |
| Locations | Taipei, Taiwan/Taipei, Taiwan |
| Start date | 2024-04-01 |
| NCT ID | NCT05927857 |
| Official listing | https://clinicaltrials.gov/study/NCT05927857 |