Actively Recruiting
Clinical Trial Evaluating Efficacy and Safety of Lenvatinib, Nivolumab, and 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness and safety of combining lenvatinib with nivolumab plus chemotherapy for patients with gastric cancer that has spread to the peritoneum and causes significant ascites (fluid buildup). Despite recent advances in treatment using immune checkpoint inhibitors like nivolumab, some patients with peritoneal metastasis and high-grade ascites still experience poor survival. This trial aims to address the unmet need for better outcomes in this group by adding lenvatinib, a drug that targets blood vessel growth factors important in tumor development. The study involves giving patients lenvatinib orally once daily, with the dose based on body weight (12 mg for those 60 kg or above, 8 mg for those under 60 kg). Patients also receive nivolumab intravenously every three weeks along with chemotherapy consisting of capecitabine taken twice daily for 14 days and oxaliplatin given intravenously on day one of each 21-day cycle. The trial has a phase 1b part to determine the recommended dose for phase 2 and a phase 2 part to assess how many patients remain free of disease progression after six months. Participants will be monitored through regular visits where doctors will assess their health, side effects, and tumor response. Tests include imaging scans to confirm peritoneal metastasis and ascites, blood tests to check organ function, and evaluations of their performance status and quality of life. The main outcomes measured are the safe dose level of the drug combination and the progression-free survival rate at six months. The study lasts several months, with ongoing assessments to ensure safety and effectiveness of the treatment.
CONDITIONS
Brief 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 confirmed by pathology
- Presence of peritoneal metastasis and grade 2 or higher malignant ascites confirmed by CT scan
- PD-L1 combined positive score of 5 or greater based on the 28-8 assay
- Able to provide signed informed consent and comply with study requirements
- Age 19 years or older at study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than 4 months
- Body weight greater than 30 kg
- No existing neuropathy
- Adequate organ and marrow function as defined by specified blood counts and organ function tests
- Female patients must be post-menopausal or have a negative pregnancy test if pre-menopausal
- Willing and able to comply with study protocol including treatment and follow-up visits
You will not qualify if you...
- Disease progression within 6 months after completing adjuvant chemotherapy
- Participation in another clinical study with an investigational product within the last 2 weeks
- Concurrent enrollment in another clinical study except for observational or follow-up studies
- Receiving any other chemotherapy, immunotherapy, biologic, or hormonal cancer treatment concurrently (except non-cancer hormonal therapy)
- Major surgery within 28 days prior to first dose
- Unable to take medication orally
- Gastrointestinal bleeding or impaired bowel absorption
- History of allogenic organ transplantation
- Uncontrolled illnesses including infection, heart failure, hypertension, unstable angina, arrhythmia, lung disease, serious gastrointestinal conditions, or psychiatric/social issues limiting compliance
- History of another primary malignancy unless treated with curative intent and no active disease for 5 years or specific low-risk skin or carcinoma in situ cancers
- Active primary immunodeficiency or infectious diseases including tuberculosis, hepatitis B or C (with conditions), or HIV
- Pregnant or breastfeeding females, or those unwilling to use effective contraception
- Known allergy to study drugs or components
- Known deficiency of dihydropyrimidine dehydrogenase (DPD)
- Known hereditary problems like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive lenvatinib daily by mouth combined with nivolumab and chemotherapy administered every 3 weeks to treat metastatic gastric cancer with malignant ascites.
Visits every 3 weeks for treatment administration and assessments
Duration - Up to 6 months after treatment
Participants are monitored for safety and progression after treatment ends.
Visits at 6 months for progression-free survival assessment
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
Research Team
H
Hyung-Don Kim
J
Jaewon Hyung
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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