Can a Chemo-Immunotherapy cocktail extend life in advanced stomach cancer?
NCT ID NCT07819019
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers are testing a combination of three drugs in adults with advanced gastric cancer that has grown after one standard chemotherapy regimen and whose tumors carry the PD-L1 protein. The drugs are irinotecan liposome (a chemotherapy wrapped in fat particles), fruquintinib (which blocks blood vessel growth to the tumor), and sintilimab (an immunotherapy that helps the immune system attack cancer). The trial aims to see how long participants live without their cancer worsening and to track side effects. About 20 people will receive the drugs by infusion or pill, with regular scans and blood tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- irinotecan liposome combined with fruquintinib and sintilimab
- What this could lead to
- If the combination works, it could offer a new second-line option for people with advanced gastric cancer whose tumors test positive for PD-L1.
- What could go wrong
- This is a small phase 2 trial with 20 participants, so results may not hold in larger studies. The three drugs can cause side effects such as nausea, diarrhea, low blood counts, and fatigue.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2030
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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18 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. Patients who fully understand the study and voluntarily sign the informed consent form (ICF). 2. Age ≥ 18 years and ≤ 80 years. 3. Patients with histopathologically confirmed unresectable or metastatic gastric cancer, with positive PD-L1 expression (CPS ≥ 1). 4. Radiologically confirmed disease progression after prior first-line standard therapy. 5. At least one measurable target lesion according to RECIST 1.1 criteria. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2. 7. Life expectancy ≥ 3 months. 8. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L, and hemoglobin ≥ 90 g/L (with no blood transfusion, no blood products, and no use of granulocyte colony-stimulating factor or other hematopoietic growth factors for correction within 14 days prior to laboratory testing). 9. Hepatic and renal function: serum creatinine ≤ 1.5 × the upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with liver metastases). 10. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment, and must be willing to use appropriate contraception during the study and for 6 months after the last dose of study drug. Exclusion Criteria: 1. Hypersensitivity to any study drug or its components. 2. Concurrent severe uncontrolled infection or other severe uncontrolled concomitant diseases, or moderate or severe renal impairment (e.g., progressive infection, uncontrolled hypertension, diabetes mellitus, etc.). 3. Cardiac function and diseases meeting any of the following: 1. Long QT syndrome or QTc interval \> 480 ms; 2. Complete left bundle branch block, or second- or third-degree atrioventricular block; 3. Severe uncontrolled arrhythmia requiring medication; 4. New York Heart Association (NYHA) class ≥ III; 5. Left ventricular ejection fraction (LVEF) \< 50%; 6. Myocardial infarction, unstable angina, history of severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically significant pericardial disease within 6 months prior to enrollment, or ECG evidence of acute ischemia or active conduction system abnormality. 4. Active hepatitis B or hepatitis C infection (hepatitis B surface antigen positive and hepatitis B virus DNA \> 1 × 10\^3 copies/mL; hepatitis C virus RNA \> 1 × 10\^3 copies/mL); asymptomatic chronic hepatitis B or hepatitis C carriers may be exempted. 5. Human immunodeficiency virus (HIV) infection (HIV antibody positive). 6. Radiologically confirmed intestinal obstruction. 7. History of or concurrent other malignancies (except adequately controlled non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment within the past five years). 8. Pregnant or lactating women, and patients of childbearing potential who are unwilling to use contraception. 9. Patients with other concurrent malignancies requiring treatment. 10. Patients judged by the investigator to be unsuitable for participation in this study. 11. History of pulmonary hemorrhage/hemoptysis ≥ grade 2 (defined as at least 2.5 mL of bright red blood) within 1 month prior to the first dose. 12. Arterial embolism, severe bleeding (excluding surgery-related bleeding), or severe bleeding tendency within 6 months prior to the first dose. 13. Symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, or spinal cord compression. 14. Use of strong inhibitors or inducers of CYP3A4, CYP2C8, or UGT1A1 within 14 days prior to study drug treatment. 15. Use of other investigational drugs within 1 month prior to the first dose. 16. Pregnant or lactating women, and subjects of childbearing potential who refuse contraception.
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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 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.
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