NCT05927857 Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .
| NCT ID | NCT05927857 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | National Health Research Institutes, Taiwan |
| Condition | Metastatic Gastric Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2024-04-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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 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 the ULN, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times the ULN or 5 times the ULN in the setting of liver metastases. 10. patients have adequate bone marrow function, defined as an absolute neutrophil count ≥ 1500/mm3, hemoglobin ≥9 g/dL, and platelet count ≥ 100,000/mm3 (transfusion or G-CSF support before enrollment is allowed) 11. patients have International Normalized Ratio (INR) ≤1.5 and a partial thromboplastin time (PTT) (PTT/aPTT) \< 1.5 x ULN; 12. patients' urinary protein is ≤1+ on dipstick or routine urinalysis or a 24-hour urine collection for protein must demonstrate \<1000 mg of protein if urine dipstick or routine analysis is ≥ 2+; 13. patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study; 14. female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose of protocol therapy; 15. the ability to understand and willingness and to sign a written informed consent document. Exclusion Criteria: 1. patient can't take oral drugs; 2. known hypersensitivity to irinotecan, fluoropyrimidine, or ramucirumab; 3. receipt of surgery within the past 4 weeks before study enrollment; 4. ≥ grade 2 diarrhea and ascites 5. concurrent severe infection with intravenous systemic antibiotics treatment; 6. 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; 7. patients have a prior history of GI perforation/fistula (within 6 months of first dose of protocol therapy) or risk factors for perforation; 8. patients have: * cirrhosis at a level of Child-Pugh B (or worse) or * cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis; 9. patients have a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy; 10. patients have undergone major surgery within 28 days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior to the first dose of protocol therapy. Patients have elective or planned major surgery to be performed during the course of the clinical trial; 11. patients have uncontrolled or poorly-controlled hypertension (\>160 mmHg systolic or \> 100 mmHg diastolic for \>4 weeks) despite standard medical management; 12. patients have experienced any grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy; 13. patients have a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to first dose of protocol therapy; 14. patients are receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted; 15. previously received prior nal-IRI (ONIVYDE®) or TAS-102 (LONSURF®) or ramucirumab therapy 16. another previous malignancy diagnosed within the past 5 years except for non melanoma skin cancer or stage I cervical cancer; 17. pregnant or breast feeding women.
Contact & Investigator
Nai-Jung Chiang, MD-PhD
PRINCIPAL INVESTIGATOR
National Health Research Institutes, Taiwan
Frequently Asked Questions
Who can join the NCT05927857 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Metastatic Gastric Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05927857 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05927857 currently recruiting?
Yes, NCT05927857 is actively recruiting participants. Contact the research team at 951106@nhri.edu.tw for enrollment information.
Where is the NCT05927857 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT05927857 clinical trial?
NCT05927857 is sponsored by National Health Research Institutes, Taiwan. The principal investigator is Nai-Jung Chiang, MD-PhD at National Health Research Institutes, Taiwan. The trial plans to enroll 45 participants.