Actively Recruiting
Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites
Led by Asan Medical Center · Updated on 2025-11-20
61
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To investigate efficacy and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.
CONDITIONS
Official Title
Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed metastatic, unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma
- Presence of peritoneal metastasis and grade 62 malignant ascites confirmed by CT scan
- PD-L1 combined positive score of 65 based on the 28-8 assay
- Able to provide signed informed consent and follow study requirements
- Age over 19 years at study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than 4 months
- Body weight over 30 kg
- No existing neuropathy
- Adequate organ and marrow function including hemoglobin 69.0 g/dL, ANC 615,000/mm3, platelet count 675,000/mm3, bilirubin 61.5 x upper limit of normal, AST/ALT 62.5 x upper limit of normal, and creatinine clearance over 40 mL/min
- Post-menopausal status or negative pregnancy test for pre-menopausal women
- Willing and able to comply with study treatment and visits
You will not qualify if you...
- Disease progression within 6 months after adjuvant chemotherapy completion
- Participation in another investigational clinical study within the last 2 weeks
- Concurrent enrollment in another interventional clinical study except observational or follow-up studies
- Receiving other chemotherapy, immunotherapy, biologic, or hormonal cancer treatments (except non-cancer hormonal therapy)
- Major surgery within 28 days prior to first dose
- Unable to take oral medication
- Gastrointestinal bleeding or impaired bowel absorption
- History of allogenic organ transplantation
- Uncontrolled illnesses such as active infection, heart failure, uncontrolled hypertension, unstable angina, arrhythmia, lung disease, serious gastrointestinal conditions, or psychiatric/social issues limiting compliance
- History of other primary malignancy unless treated with curative intent over 5 years ago or adequately treated skin cancer or carcinoma in situ
- History of active primary immunodeficiency
- Active infectious diseases including tuberculosis, hepatitis B or C, or HIV infection
- Pregnant or breastfeeding women, or patients unwilling to use effective contraception
- Known allergy to study drugs
- Known deficiency of dihydropyrimidine dehydrogenase (DPD)
- Known hereditary metabolic disorders such as galactose intolerance or lactase deficiency
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
Research Team
H
Hyung-Don Kim
CONTACT
J
Jaewon Hyung
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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