Neoadjuvant Systemic and Peritoneal Chemotherapy for Advanced Gastric Cancer

Launched by IMPERIAL COLLEGE LONDON · Apr 1, 2022

Keywords

ClinConnect Summary

This clinical trial, called "Neoadjuvant Systemic and Peritoneal Chemotherapy for Advanced Gastric Cancer," aims to explore a new treatment method for patients with advanced gastric cancer that has spread to the lining of the abdomen. The study will investigate whether a technique called PIPAC, which delivers chemotherapy directly into the abdominal cavity, can enhance the effectiveness of standard chemotherapy when given together. This approach is being tested for patients who have specific conditions, such as a type of stomach cancer known as gastric adenocarcinoma, and who show signs of limited spread in the abdomen.

To be eligible for the study, participants must be adults with certain health conditions, including having a specific type of gastric cancer that hasn’t been treated before and showing minimal spread in the abdomen. They must also meet some health criteria, such as having a stable body weight and not having severe other health issues. Those who join the trial can expect to receive the new treatment along with standard care, and they will be closely monitored throughout the process. It's important to note that the trial is not yet recruiting patients, so interested individuals should stay in touch with their healthcare providers for updates.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Gastric adenocarcinoma (Tx, Nx) 1,2,3
• • Peritoneal cytology +ve or PCI ≤ 3
• • No solid organ metastasis 2
• • HER2 -ve
• • Male/female
• • Treatment naïve
• • BMI ≥ 18.5 kg/m2 or ≤ 40 kg/m2
• • WHO performance status ≤ 1
• • Dysphagia score ≤ 2
• • Informed written consent
• Exclusion Criteria:
• • PCI ≥ 4
• • Solid organ metastasis
• • Positive lymph node disease beyond field of D2 lymphadenectomy
• • Peritoneal adhesions precluding complete laparoscopy
• • Ascites (greater than trace amount)
• • Malignant pleural effusion
• • Mechanical bowel obstruction (with the exception of gastric outlet obstruction)
• • HER2 +ve
• • Patients eligible for immunotherapy
• • Uncontrolled co-morbidity
• • single/multiple organ failure
• • BMI \< 18.5 kg/m2 or \> 40 kg/m2
• • WHO performance status \> 1
• • Dysphagia score \> 2
• • Contraindication to chemotherapy
• • Pregnancy or breastfeeding
• • Haemoglobin \<90 g/dL uncorrected with blood transfusion