Study of Lenvatinib with Nivolumab and Chemotherapy for Treating Metastatic Gastric Cancer with Malignant Ascites

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.

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