Neoadjuvant Systemic and Peritoneal Chemotherapy for Advanced Gastric Cancer

• Status: Not yet recruiting
• Trial end date: 2029-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Data demonstrating the efficacy of PIPAC in patients with regionally advanced gastric cancer with positive peritoneal cytology and/or minimal peritoneal disease is limited due to the relatively recent development of this technique and its historical preferential use in palliative patients with disseminated peritoneal metastasis.

Existing data suggest PIPAC administered every six weeks in conjunction with standard treatment may work as an adjunct to conventional systemic neoadjuvant chemotherapy. PIPAC protocols have been established both for gastric cancer as well as other intra-abdominal malignancies and have a good safety profile.

Given these promising findings, a study protocol is proposed herein to further investigate PIPAC for the treatment of a highly selected group of patients with regionally advanced gastric cancer (positive peritoneal cytology and/or minimal peritoneal disease).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: Doxorubicin

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