New cocktail of drugs shows promise for stomach cancer patients
NCT ID NCT05927857
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with advanced stomach cancer that has spread and who have already tried one type of treatment. It tests a combination of three drugs (ramucirumab, nal-IRI, and trifluridine/tipiracil) to see if they can shrink tumors and help patients live longer. The study has two phases: first to find the best dose, then to measure how well the treatment works. About 45 participants will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Taipei Veterans General Hospital
RECRUITINGTaipei, Taiwan/Taipei, Taiwan
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