The Application of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Surface Malignancies

Launched by THE UNIVERSITY OF HONG KONG · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for patients with peritoneal metastases, which is cancer that has spread to the lining of the abdomen. The researchers want to see if this method, which delivers chemotherapy directly into the abdomen in a fine mist, is safe and effective for patients with certain types of advanced cancers, specifically colorectal, gastric, and pancreatic cancers. The trial will include patients aged 18 and older who have not received treatment before or who have had issues with their first treatment. Participants will receive PIPAC treatment along with other chemotherapy over a period of about three years.

If you join the trial, you can expect to undergo three cycles of PIPAC treatment, with each cycle spaced about 6 to 8 weeks apart. The doctors will closely monitor your health and any side effects you may experience. They will also evaluate how well the treatment is working and whether it might make your cancer operable in the future. It's important to note that this trial is looking for patients who meet specific criteria, such as being in good overall health and having a confirmed diagnosis of cancer without any other major health issues.

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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