Recruiting

Lenvatinib, Nivolumab, and Chemotherapy for Metastatic Gastric Cancer With Malignant Ascites

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What is being tested

Lenvatinib

Drug
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

Over 19 Years
+34 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorAsan Medical Center
Study ContactHyung-Don KimMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 11, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on finding better treatment options for patients with advanced gastric cancer that has spread to the lining of the abdomen, causing a buildup of fluid known as ascites. Current treatments using a combination of chemotherapy and immune therapy, like nivolumab, have shown improvements in survival rates. However, patients with specific conditions such as peritoneal metastasis and significant ascites have not had as good outcomes. This study aims to explore whether adding lenvatinib, a drug that targets tumor growth by blocking certain pathways, can enhance the effectiveness of the existing treatment combination. Participants in this trial will receive lenvatinib along with nivolumab and chemotherapy. The study seeks to determine if this combination can improve survival outcomes for patients who have been difficult to treat with current methods. The treatment will be administered through injections and pills, and researchers will monitor the participants closely to evaluate the drug's effectiveness and safety. The hope is that this combination could offer a new, more effective treatment for those facing this challenging condition and improve their quality of life.

Official TitleA Clinical Trial Evaluating the Efficacy and Safety of Lenvatinib, Nivolumab, and Chemotherapy in Metastatic Gastric Cancer With Malignant Ascites.
Principal SponsorAsan Medical Center
Study ContactHyung-Don KimMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

61 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by SiteStomach DiseasesStomach Neoplasms

Criteria

12 inclusion criteria required to participate
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

Newly diagnosed pathologically proven metastatic, unresectable or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma

Age \> 19 years at time of study entry

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

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22 exclusion criteria prevent from participating
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

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.

Active infectious disease

Hepatitis C (patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Asan Medical Center

Seoul, South KoreaOpen Asan Medical Center in Google Maps
Recruiting
One Study Center
Lenvatinib, Nivolumab, and Chemotherapy for Metastatic Gastric Cancer With Malignant Ascites | PatLynk