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COMPLETEDPHASE1

Concomitant Intraperitoneal and Systemic Chemotherapy in Patients With Extensive Peritoneal Carcinomatosis of Gastric Origin

NCT05379790•Erasmus Medical Center

Summary

Gastric cancer with peritoneal carcinomatosis has a poor prognosis, with little treatment options available. The current treatment strategy consists of palliative systemic chemotherapy. However, previous research suggests that systemic chemotherapy is less effective against peritoneal carcinomatosis than against metastases that spread hematogenously. Several studies suggested that in patients with peritoneal carcinomatosis, intraperitoneal chemotherapy (IP) may be superior compared to intravenous chemotherapy. Intraperitoneal chemotherapy could lead to higher concentrations of chemotherapy in the peritoneal cavity for a longer period of time, resulting in an increased cumulative exposure to the peritoneal metastases. A few Asian studies have shown promising results with intraperitoneal chemotherapy in patients with peritoneal carcinomatosis of gastric origin. However, intraperitoneal chemotherapy combined with systemic chemotherapy has not been investigated in Western patients with peritoneal carcinomatosis of gastric origin yet. The objective of this trial is to establish the maximum tolerated dose (MTD) of intraperitoneal administration of irinotecan, added to systemic capecitabine/oxaliplatin (CAPOX) in patients with peritoneal carcinomatosis of gastric origin.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with a histologically confirmed diagnosis of HER2-negative gastric cancer.
•A histologically confirmed diagnosis of peritoneal carcinomatosis.
•Age ≥ 18 years old.
•Written informed consent according to the ICH-GCP and national/local regulations.
•A peritoneal cancer index (PCI) ≥7 evaluated by laparoscopy or laparotomy before inclusion in this trial.
•Patients must be ambulatory: World Health Organisation (WHO) performance status 0 or 1.
•Life expectancy of at least 3 months.
•Ability to return to the Erasmus MC for adequate follow-up as required by this protocol.
•Patients must have normal organ function and adequate bone marrow reserve as assessed by the following laboratory requirements:
•* absolute neutrophil count \>1.5 \* 10\^9/l;
+5 more criteria

Exclusion Criteria

•Medical or psychological impediment to probable compliance with the protocol.
•Serious concomitant disease or active infections.
•Distant metastasis other than peritoneal metastasis or metastatic lymph nodes.
•No sufficient oral food intake.
•Polyneuropathy grade 2 or worse according to CTCAE version 5.0.
•History of auto-immune disease or organ allografts, or with active or chronic infection, including HIV and viral hepatitis.
•Serious intercurrent chronic or acute illness such as pulmonary (COPD or asthma) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinator to constitute an unwarranted high risk for participation in this study.
•Homozygous UGT1A1\*28 genotype.
•Homozygous dihydropyrimidine dehydrogenase (DPYD) genotype (tested for \*2A, \*13, 2846A\>T, and 1236G\>A).
•Current use of strong CYP3A4-inhibitors or inducers. If patients use this CYP3A4-modulating medication, it is allowed to stop it within 14 days of start of treatment.
+4 more criteria

Locations (2)

Erasmus MC

Rotterdam, South Holland, Netherlands

Catharina Hospital

Eindhoven, Netherlands

Key Dates

Start Date

May 25, 2022

Primary Completion Date

November 25, 2024

Completion Date

February 17, 2025

Last Updated

April 1, 2025

Enrollment

ACTUAL participants

Conditions

Gastric CancerPeritoneal Metastases

Interventions

Irinotecan

DRUG

CAPOX

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Concomitant Intraperitoneal and Systemic Chemotherapy in Patients With Extensive Peritoneal Carcinomatosis of Gastric Origin

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Resilience and Equity in Aging, Cancer, and Health (REACH)

Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.