Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .

Launched by NATIONAL HEALTH RESEARCH INSTITUTES, TAIWAN · Jun 25, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a combination of three medications—Ramucirumab (Cyramza), Nal-IRI (ONIVYDE), and Trifluridine/Tipiracil (Lonsurf)—to see if they can help patients with metastatic gastric cancer who have already received one type of treatment. The main goal is to find the highest dose of Nal-IRI that can be safely given alongside the other two medications and to see how effective this combination is in shrinking tumors or controlling the disease.

To participate in this trial, patients need to have a confirmed diagnosis of metastatic gastric adenocarcinoma and should have only had one prior treatment. They must be between 20 and 80 years old and have a life expectancy of at least three months. Additionally, they need to meet certain health criteria, like having good kidney and liver function. Participants can expect to receive close monitoring during the trial to assess how their body responds to the treatment and to ensure their safety. It’s important to note that this trial is not yet recruiting participants, so there’s still some time before it begins.

Gender

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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 nonmelanoma skin cancer or stage I cervical cancer;
• • 17. pregnant or breastfeeding women.