RecruitingPhase 1Phase 2NCT07149090

Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites

A Clinical Trial Evaluating the Efficacy and Safety of Lenvatinib, Nivolumab, and Chemotherapy in Metastatic Gastric Cancer With Malignant Ascites.


Sponsor

Asan Medical Center

Enrollment

61 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To investigate efficacy and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of targeted therapy (lenvatinib), immunotherapy (nivolumab), and standard chemotherapy in patients with advanced gastric (stomach) or gastroesophageal junction cancer that has spread to the lining of the abdomen (peritoneal metastasis) with fluid buildup (malignant ascites). **You may be eligible if...** - You are older than 19 years - You have been newly diagnosed with metastatic, unresectable, or recurrent gastric/GEJ adenocarcinoma - Your cancer has spread to the peritoneum (abdominal lining) with significant fluid buildup (grade 2 or higher ascites confirmed by CT scan) - Your tumor tests positive for PD-L1 (CPS ≥5), a marker that indicates immunotherapy may be effective - You are in good enough physical condition (ECOG performance status assessed by your doctor) **You may NOT be eligible if...** - Your cancer does not have peritoneal metastasis or high enough PD-L1 expression - You have significant organ dysfunction or other conditions making this combination unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenvatinib

Description: Lenvatinib: 12 mg (for body weight ≥ 60 kg) or 8 mg (for body weight \< 60 kg) per oral once daily * Dose level 1: 8mg per oral once daily (for \<60kg) 12mg per oral once daily (for ≥ 60kg) * Dose level 2: 4mg per oral once daily (for \<60kg) 8mg per oral once daily (for ≥ 60kg) Nivolumab: 360 mg administered intravenously every 3 weeks Chemotherapy(Oxaliplatin+Capecitabine) every 3 weeks * Capecitabine 1000 mg/m² per oral twice daily on Days 1-14 * Oxaliplatin 130 mg/m² administered intravenously on Day 1


Locations(1)

Asan Medical Center

Seoul, South Korea

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NCT07149090


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