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

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).

Conditions

• Peritoneal Carcinoma Metastatic

Interventions

DRUG

Pressurized Intraperitoneal Aerosol Chemotherapy

The 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.

Sponsors & Collaborators

• Tianjin Third Central Hospital

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Tongji Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Jiangxi Provincial Cancer Hospital

  collaborator OTHER

• The First Affiliated Hospital of Air Force Medicial University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• Affiliated Hospital of Qinghai University

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Shenzhen Second People's Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Tianjin Nankai Hospital

  collaborator OTHER

• Wannan Medical College Yijishan Hospital

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Changzhi People's Hospital

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Sixth Affiliated Hospital, Sun Yat-sen University

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-11

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• China

Study Locations