Phase IbII Study of Intraperitoneal Liposomal Irinotecan Alone or With Modified Human Tumor Necrosis Factor or Bevacizumab for Treating Malignant Ascites After Standard Therapy Failure

What this Trial Is About

Researchers are conducting a Phase IbII clinical trial to evaluate treatments for malignant peritoneal effusion, a condition where fluid builds up in the abdomen due to cancer that has not responded to standard therapies. The study aims to explore the safety and dosing of liposomal irinotecan administered into the abdominal cavity and to assess its effectiveness alone or combined with other drugs in patients who have failed prior treatments. The study has two stages. The first is a dose-escalation phase where patients receive increasing doses of liposomal irinotecan via intraperitoneal injection on Days 1, 8, 15, and 21 to determine the maximum tolerated dose. The second stage expands to test liposomal irinotecan alone or combined with recombinant mutant human tumor necrosis factor or bevacizumab given on specific schedules. Each participant receives treatment cycles, and doses are monitored carefully for safety. Participants will undergo various tests and evaluations during treatment, including safety monitoring, response assessments, and quality of life measurements over about one year. Researchers will track the maximum tolerated dose, response rates, duration of response, disease control, and side effects. Follow-up continues to evaluate treatment impact and participant well-being throughout the study period up to the end date in June 2029.

Intraperitoneal Injection of Liposomal Irinotecan as Monotherapy or in Combination With Recombinant Mutant Human Tumor Necrosis Factor or Bevacizumab for the Treatment of Malignant Ascites Following Failure of Prior Standard Therapy