A Multi-center Study Evaluating Safety and Effectiveness of Pressurized Intraperitoneal Aerosol Chemotherapy Using a New Drug Delivery System for Peritoneal Metastatic Adenocarcinoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of pressurized intraperitoneal aerosol chemotherapy PIPAC delivered through a new nebulized drug delivery system NDDS for patients with peritoneal metastatic adenocarcinoma PMA originating from gastric, colorectal, appendiceal, or ovarian cancers. This prospective, multi-center, single-arm trial aims to provide data especially for Asian populations, as current evidence primarily comes from Western countries. The study focuses on assessing adverse events, device performance, pain levels, and quality of life, along with other important cancer-related outcomes. The novel NDDS includes a central computer, high-pressure pump, spray nozzle, and safety features to deliver chemotherapy drugs under a standard pressure during PIPAC. Patients receive three cycles of PIPAC combined with systemic chemotherapy regimens like XELOX or FOLFOX. The interval between PIPAC treatments is 4 to 6 weeks, with systemic chemotherapy timed 1 to 2 weeks apart from PIPAC. Drug choices differ based on cancer origin doxorubicin and cisplatin for gastric or ovarian cancers, and oxaliplatin for colorectal or appendiceal cancers. Participants will be monitored through scheduled assessments including adverse events tracking within weeks after PIPAC procedures, device defect checks, daily pain scoring for one week post-treatment, and quality of life questionnaires at multiple time points. Additional evaluations during PIPAC include cancer indices, regression grading, response rates, ascites improvement, and survival measures. The study is conducted in 25 medical centers with follow-up extending up to six months post-treatment, aiming to enroll about 30 patients.

The Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Metastatic Adenocarcinoma