Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis

What Was Tested

This registered phase 2 trial tested Pasireotide.

It had two arms (groups): Pasireotide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 6 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female patients aged between 18 years and 75 years included. ECOG (Eastern Cooperative Oncology Group) Performance Status ≤ 2. Primary (pseudomyxoma peritonei, peritoneal mesothelioma) or Secondary (colorectal or ovarian) peritoneal malignancies.

The full record lists 4 inclusion and 20 exclusion criteria; among the exclusions: absence of extra-peritoneal metastatic disease or limited hepatic or lung metastases easily amenable to curative-intent resection or ablation; visceral resection with at least one digestive anastomosis with or without loop ileostomy or pancreatic or biliary resection; negative serum pregnancy test for women of childbearing potential within 7 days prior to therapy.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Pasireotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Pasireotide was given.

Those kept unaware of assignments: participant.

It started in 2020-09-03 with completion listed for 2024-02-07.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): postoperative digestive leakage (time frame: 97 days).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Pasireotide in 6 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Pasireotide compound page, all human trials.