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Trial Title:
The Application of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Surface Malignancies
NCT ID:
NCT06367270
Condition:
Peritoneal Metastases
Conditions: Official terms:
Neoplasm Metastasis
Peritoneal Neoplasms
Conditions: Keywords:
Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC)
Peritoneal metastases
Oxaliplatin
Intraperitoneal chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pressured Intraperitoneal Aerosol Chemotherapy
Description:
PIPAC cycles will be scheduled every 6-8 weeks and 2 weeks after the last systemic
chemotherapy administration. The bidirectional program for the combination of
intraperitoneal and systemic chemotherapy is designed as follows: systemic chemotherapy
followed by PIPAC two weeks later, followed by a one-week interval, and then systemic
chemotherapy once again until three PIPAC cycles have been completed. Up to a one-week
delay in returning to systemic chemotherapy after PIPAC and vice versa were considered
acceptable. Systemic drug choice was based on previous chemotherapy exposure and the
medical oncologists' decision. The study ends after the 3rd cycle of PIPAC.
Arm group label:
PIPAC
Other name:
PIPAC
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. ≥18 years of old;
2. WHO performance of status 0-1;
3. Histologically or cytologically proven PM of a gastric, pancreatic or colorectal
carcinoma;
4. Treatment naïve patients as first-line treatment;
5. Progression on or intolerance to first-line systemic chemotherapy as second-line
treatment;
6. No symptoms of gastrointestinal obstruction;
7. No contraindications for the planned systemic therapy or laparoscopy;
8. No previous PIPAC/IP/HIPEC;
9. No other concurrent malignancies or any other malignancy within 6 months prior to
enrolment;
10. Able to give written informed consent.
Exclusion Criteria:
1. A history of allergic reaction to platinum containing compounds or doxorubicin;
2. Pregnant or breastfeeding;
3. Any extra-peritoneal metastases;
4. Renal impairment, defined as GFR less than 40 mL/min;
5. Impaired liver function defined as bilirubin over 1.5 × UNL;
6. Inadequate haematological function
- Leucocyte < 3.00 × 109/L
- Absolute neutrophil counts < 1.50 × 109/L
- Platelet < 100 × 109/L
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Queen Mary Hospital
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Ian WONG, Dr.
Phone:
+852 2255 4774
Email:
iyhwong@hku.hk
Investigator:
Last name:
Ian WONG, Dr.
Email:
Principal Investigator
Start date:
September 1, 2023
Completion date:
August 31, 2027
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Source:
The University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06367270
