The Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Metastatic Adenocarcinoma
Status:
RECRUITING
Trial end date:
2026-09-30
Target enrollment:
Participant gender:
Summary
This research is a prospective, multi-center, single-arm clinical trial aimed at assessing the standard pressurized intraperitoneal aerosol chemotherapy (PIPAC) utilizing a novel nebulized drug delivery system (NDDS) for patients with peritoneal metastatic adenocarcinoma (PMA) originating from gastric, colorectal, appendiceal, or ovarian cancer.
The primary objectives of this study are to assess the safety and efficacy of PIPAC with the novel NDDS in the treatment of PMA. Primary endpoints include adverse events (AEs) and serious AEs, as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, incidences of device defects, postoperative pain scores evaluated using the Visual Analogue Scale / Score (VAS), and quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 scale, Version 3.0). Secondary endpoints include the intra-abdominal peritoneal cancer index (PCI), peritoneal regression grading score (PRGS), objective response rate (including partial response (PR) and complete response (CR)), improvement in ascites, conversion rate (patients proceeding to cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) following initial PIPAC treatments), progression-free survival (PFS), and overall survival (OS).
Phase:
PHASE1
Details
Lead Sponsor:
Guangdong Provincial People's Hospital
Collaborators:
Affiliated Hospital of Qinghai University Changzhi People's Hospital First Hospital of China Medical University Fujian Medical University Union Hospital Henan Cancer Hospital Jiangxi Provincial Cancer Hospital Nanfang Hospital, Southern Medical University Peking University Cancer Hospital & Institute Ruijin Hospital Second Affiliated Hospital of Guangzhou Medical University Second Affiliated Hospital of Wenzhou Medical University Shenzhen Second People's Hospital Sixth Affiliated Hospital, Sun Yat-sen University Southern Medical University, China Sun Yat-sen University The First Affiliated Hospital of Air Force Medicial University The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine Tianjin Nankai Hospital Tianjin Third Central Hospital Tongji Hospital Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wannan Medical College Yijishan Hospital West China Hospital Xiangya Hospital of Central South University