Phase 1 Study of Nab-Paclitaxel Delivered as Pressurized Intraperitoneal Aerosolized Chemotherapy Combined With Paclitaxel and Ramucirumab for Advanced Stomach Cancer with Peritoneal Spread

What this Trial Is About

Researchers are studying a new way to treat stomach cancer that has spread to the lining of the abdomen, called peritoneal metastases. This phase 1 trial is testing the safety, side effects, and best dose of a chemotherapy drug called nab-paclitaxel delivered as a pressurized aerosol directly into the abdomen PIPAC. The study also evaluates how well this treatment works when combined with standard second-line chemotherapy drugs paclitaxel and ramucirumab. Nab-paclitaxel is a special form of paclitaxel that may have fewer side effects and better delivery to tumors. Ramucirumab is an antibody that may stop tumors from growing new blood vessels. Participants receive nab-paclitaxel through PIPAC into the abdomen on day 1 of each cycle. They also receive paclitaxel and ramucirumab intravenously on specific days within an 8-week cycle, which may be repeated up to three times if the disease does not progress or side effects are tolerable. After this, patients may continue with paclitaxel and ramucirumab on a 28-day cycle as decided by their doctor. Throughout the study, patients undergo blood tests, tumor biopsies, and imaging scans such as CT or MRI. During the trial, researchers closely monitor participants for side effects and dose limits, tumor response using imaging and biopsy scores, progression of cancer, and overall survival. They also assess patient quality of life and symptoms at different time points. After treatment ends, patients are followed for up to two years with regular visits to track their health and any new treatments. The study aims to find the best dose and gather information about safety, effectiveness, and how the tumor environment changes with therapy.

Nab-Paclitaxel PIPAC in Combination With Paclitaxel and Ramucirumab for the Treatment of Stomach Cancer With Peritoneal Metastases