Triple-Drug cocktail targets stomach cancer that has spread to the abdomen
NCT ID NCT07149090
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of three drugs—lenvatinib, nivolumab, and chemotherapy—in people with advanced stomach cancer that has spread to the lining of the abdomen and caused fluid buildup (ascites). The goal is to see if this triple therapy can shrink tumors and help patients live longer without the cancer getting worse. The trial is enrolling 61 participants and includes two phases: first to find the safest dose, then to measure how well it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lenvatinib, nivolumab, and chemotherapy (capecitabine + oxaliplatin)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced gastric cancer and malignant ascites, potentially slowing disease progression and extending life.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with only 61 participants, so results are preliminary. The drug combination may cause significant side effects, and it is not yet known if it will work better than standard treatments.
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 61 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jul 2027
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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19 years and older
- 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. Newly diagnosed pathologically proven metastatic, unresectable or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma 2. Positive for peritoneal metastasis and grade ≥ 2 malignant ascites as confirmed by computed tomography (CT) 3. PD-L1 combined positive score of ≥5 based on the 28-8 assay 4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations 5. Age \> 19 years at time of study entry 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Life expectancy of \> 4 months 8. Body weight \> 30kg 9. No existing neuropathy 10. Adequate normal organ and marrow function as defined below: * Hemoglobin ≥9.0 g/dL * Absolute neutrophil count (ANC) 1.5 x (\> 1500 per mm3) * Platelet count ≥100 (or 75) x 109/L (\>75,000 per mm3) * Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN) * AST (SGOT)/ALT (SGPT) ≤2.5 x institutional ULN * Measured creatinine clearance (CL) \> 40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance: 11. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre- menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. 12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up Exclusion Criteria: 1. Disease progression within 6 months after completion of adjuvant chemotherapy. 2. Participation in another clinical study with an investigational product during the last 2 weeks 3. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study 4. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable 5. Major surgical procedure within 28 days prior to the first dose 6. Unable to take medication orally 7. Gastrointestinal bleeding 8. Impaired bowel absorption 9. History of allogenic organ transplantation 10. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent 11. History of another primary malignancy except for * Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose and of low potential risk for recurrence * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease * Adequately treated carcinoma in situ without evidence of disease 12. History of active primary immunodeficiency 13. Active infectious disease 14. Tuberculosis (based on clinical history, physical examination, radiographic findings, and TB testing in line with local practice) 15. Hepatitis B (known positive HBV surface antigen (HBsAg) result) 16. Hepatitis C (patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA) 17. Human immunodeficiency virus (positive HIV 1/2 antibodies) 18. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. 19. Female patients who are pregnant or breastfeeding, as well as male or female patients of reproductive potential who are not willing to use effective contraception from the time of screening until 5 months following the final dose of lenvatinib. 20. Known allergy or hypersensitivity to the investigational drug or any of its components. 21. Patients with known deficiency of dihydropyrimidine dehydrogenase (DPD). 22. Patients with known hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
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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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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
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