Recruiting PHASE2 Peritoneal Metastases

New treatment option for Peritoneal Metastases

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

ClinicalTrials.gov ID: NCT06367270

What this study is testing

What is Pressured Intraperitoneal Aerosol Chemotherapy?

Pressured Intraperitoneal Aerosol Chemotherapy is an investigational medicine, being studied as a potential treatment for peritoneal metastases.

Also referred to as PIPAC.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works
  • This is a blinded study.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • ≥18 years of old;
  • WHO performance of status 0-1;
  • Histologically or cytologically proven PM of a gastric, pancreatic or colorectal carcinoma;
  • Treatment naïve patients as first-line treatment;
  • Progression on or intolerance to first-line systemic chemotherapy as second-line treatment;

You likely can't join if

  • A history of allergic reaction to platinum containing compounds or doxorubicin;
  • Pregnant or breastfeeding;
  • Any extra-peritoneal metastases;
  • Renal impairment, defined as GFR less than 40 mL/min;
  • Impaired liver function defined as bilirubin over 1.5 × UNL;
  • Inadequate haematological function
See the full eligibility criteria
Who can join
  • ≥18 years of old;
  • WHO performance of status 0-1;
  • Histologically or cytologically proven PM of a gastric, pancreatic or colorectal carcinoma;
  • Treatment naïve patients as first-line treatment;
  • Progression on or intolerance to first-line systemic chemotherapy as second-line treatment;
  • No symptoms of gastrointestinal obstruction;
  • No contraindications for the planned systemic therapy or laparoscopy;
  • No previous PIPAC/IP/HIPEC;
  • No other concurrent malignancies or any other malignancy within 6 months prior to enrolment;
  • Able to give written informed consent.
What rules you out
  • A history of allergic reaction to platinum containing compounds or doxorubicin;
  • Pregnant or breastfeeding;
  • Any extra-peritoneal metastases;
  • Renal impairment, defined as GFR less than 40 mL/min;
  • Impaired liver function defined as bilirubin over 1.5 × UNL;
  • Inadequate haematological function
  • Leucocyte \< 3.00 × 109/L
  • Absolute neutrophil counts \< 1.50 × 109/L
  • Platelet \< 100 × 109/L

The study team makes the final eligibility decision.

Where it's taking place

  • Hong Kong, Hong Kong

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.