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New treatment option for Metastatic Gastric Adenocarcinoma
Official title Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .
ClinicalTrials.gov ID: NCT05927857
What this study is testing
What is nal-IRI /Experimental?
nal-IRI /Experimental is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic gastric adenocarcinoma.
Also referred to as ONIVYDE.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 80
You may be able to join if
- 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...
- 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;
You likely can't join if
- patient can't take oral drugs;
- 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...
See the full eligibility 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;
- 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...
- 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)
- patients have International Normalized Ratio (INR) ≤1.5 and a partial thromboplastin time (PTT) (PTT/aPTT) \< 1.5 x ULN;
- 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+;
- patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study;
- female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose of protocol therapy;
- the ability to understand and willingness and to sign a written informed consent document.
- patient can't take oral drugs;
- 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...
- patients have a prior history of GI perforation/fistula (within 6 months of first dose of protocol therapy) or risk factors for perforation;
- 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...
- patients have a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy;
- 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 uncontrolled or poorly-controlled hypertension (\>160 mmHg systolic or \> 100 mmHg diastolic for \>4 weeks) despite standard medical management;
- patients have experienced any grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy;
- 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...
- patients are receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted;
- previously received prior nal-IRI (ONIVYDE®) or TAS-102 (LONSURF®) or ramucirumab therapy
- another previous malignancy diagnosed within the past 5 years except for non melanoma skin cancer or stage I cervical cancer;
- pregnant or breast feeding women.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan/Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan/Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.