Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06367270
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-10
Brief Title:
The Application of Pressured Intraperitoneal Aerosol Chemotherapy PIPAC for Peritoneal Surface Malignancies
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
The Application of Pressured Intraperitoneal Aerosol Chemotherapy PIPAC for Peritoneal Surface Malignancies
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIPAC
Brief Summary:
Pressurized intraperitoneal aerosol chemotherapy PIPAC is a novel minimally invasive drug delivery system for patients with peritoneal metastases PM It has been considered as a safe and feasible palliative treatment alternative proven by previous phase I studies Currently available evidence on feasibility efficacy and tolerability in Asian populations is limited In this open-label single-arm monocentric clinical trial investigators aim to evaluate the therapeutic efficacy and complications of PIPAC with oxaliplatin as an alternative on patients of unresectable colorectal cancer with PM and doxorubicin and cisplatin on patients of unresectable gastric and pancreatic cancers with PM Alternative regimen can be considered multidisciplinary tumour board meeting Patients will be recruited according to the inclusion criteria and treated for 3 cycles of PIPAC and concurrent systemic chemotherapy The goal was to repeat PIPAC every 6-8 weeks for at least three procedures and the delay of the systemic chemotherapy is 2 weeks before and after each PIPAC procedure If PM was considered to become resectable during PIPAC patients were discussed at the multidisciplinary tumour board for curative intent cytoreductive surgery CRS and hyperthermic intraperitoneal chemotherapy HIPEC The primary outcome is the clinical benefit rate CBR measured by an independent radiologist according to Response Evaluation Criteria In Solid Tumors RECIST and Peritoneal Cancer Index PCI assessed by laparoscopy and histopathological tumour response evaluated by pathologists blinded to clinical outcomes Key secondary outcomes include the major and minor treatment-related adverse events according to the Common Terminology Criteria for Adverse Events CTACE up to 4 weeks after the treatment Cytological tumour response of peritoneal lavage or ascites treatment-related characteristics hospital stay progression-free survival overall survival and readmission rate The proposed study duration is 3 years from the start date and the estimated sample size is 51 according to centre capacity
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None