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).
Histopathology verified that peritoneal metastatic adenocarcinoma (PMA) arises from gastric, colorectal, appendiceal, or ovarian carcinoma;
Applicable to individuals of either sex, aged between 18 and 75 years;
Eastern Cooperative Oncology Group (ECOG) scale ≤ 2;
Absence of other concurrent malignancies;
Presenting symptoms of gastrointestinal obstruction;
Fully reliant on parenteral nutrition;
Exhibiting decompensated ascites;
Suffering from severe abdominal infection (indications of peritonitis);
Single group
Pressurized Intraperitoneal Aerosol Chemotherapy
DrugThe comprehensive therapeutic strategy will be modified based on the integrated 2- or 3-week systemic chemotherapies. In the interim, a total of three PIPAC procedures will be conducted for all qualifying patients. 1. PIPAC combined with 2-week systemic chemotherapies: PIPAC therapy will occur every four weeks, while systemic chemotherapies will be administered during the first and third weeks following the initial and second PIPAC procedures respectively. 2. PIPAC combined with 3-week systemic chemotherapies: (1) Scheme 1: PIPAC therapy will occur every 6 weeks, with systemic chemotherapies administered during the 1st and 4th weeks following the first and second PIPAC procedures, respectively. (2) Scheme 2: PIPAC therapy will occur every 6 weeks, while systemic chemotherapies will be administered in the 2nd and 5th weeks following the initial and second PIPAC procedures, respectively.
Adverse Events (AE) and serious AE associated with Treatment
Treatment-related adverse events are categorized according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Elevated grades correlate with increased severity of adverse events
Incidences of device defects
Incidences of device defects during PIPAC therapy
Postoperative pain scores
Postoperative pain is assessed using the Visual Analogue Scale/Score (VAS), which integrates the Wong-Baker Faces Pain Scale Revision (FPS-R) and the Numerical Rating Scale (NRS). Scores vary from 0 to 10, with 1-3 indicating "mild pain (sleep unaffected)", 4-6 indicating "moderate pain (sleep disruption)", and 7-10 indicating "severe pain (severe sleep disruption)".
Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Version 3.0)
The quality of life is assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 scale, Version 3.0). A higher comprehensive score indicates superior quality of life.
Intra-abdominal peritoneal cancer index (PCI)
The peritoneal cancer index (PCI) is assessed based on the presence and dimensions of peritoneal metastases in various areas of the abdominal cavity. Elevated PCI scores indicate a greater peritoneal tumor burden.
Peritoneal regression grading score (PRGS)
The peritoneal regression grading score is assessed through the pathological examination of biopsies from the four quadrants (right upper/lower and left upper/lower) of the anterior abdominal wall, correlating with the ratio of residual active to necrotic tumor cells. The grading scores span from 1 to 4, with lower scores indicating fewer residual active tumor cells.
Objective response rate (partial and complete response)
The objective response rate, encompassing both partial and complete responses, is assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Improvement in ascites
The volume and hue of ascites are documented and assessed
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Guangdong Provincial People's Hospital
Lead sponsor
Tianjin Third Central Hospital
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Collaborator
Henan Cancer Hospital
Collaborator
Tongji Hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Jiangxi Provincial Cancer Hospital
Collaborator
The First Affiliated Hospital of Air Force Medicial University
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
Southern Medical University, China
Collaborator
Affiliated Hospital of Qinghai University
Collaborator
Ruijin Hospital
Collaborator
Shenzhen Second People's Hospital
Collaborator
West China Hospital
Collaborator
Tianjin Nankai Hospital
Collaborator
Wannan Medical College Yijishan Hospital
Collaborator
Second Affiliated Hospital of Wenzhou Medical University
Collaborator
Changzhi People's Hospital
Collaborator
First Hospital of China Medical University
Collaborator
Xiangya Hospital of Central South University
Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Fujian Medical University Union Hospital
Collaborator
