gastro-esophageal cancer stomach and esophageal cancer gastric cancer and stomach cancer
Conditions
Interventions
Fecal capsules from healthy donors. Patients should take one capsule once a day
for a total of 4 weeks prior to each preoperative chemotherapy treatment for 7
days. An operation will take place afte
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients -Resectable adenocarcinoma of the stomach or gastro*esophageal junction; planned start with neo-adjuvant FLOT -Patient is fit for surgery Healthy fecal donors -Lean body mass of 80% or more
Exclusion criteria
Exclusion criteria: Patients Past (within 5 years) or current history of malignancy other than entry diagnosis interfering with prognosis of gastro-esophageal cancer, not including superficial and adequately treated skin and cervical malignancies. History of a non-malignant disease of the digestive tract, such as celiac disease, chronic diarrhoea (>=3 stools/day for >4 weeks), chronic obstipation (3 months), Irritable Bowel Syndrome (IBS) (according to Rome IV criteria) or Inflammatory Bowel Disease (IBD). Uncontrolled (bacterial) infections Healthy fecal donors -Use of antibiotics -Infections such as HIV, hepatitis B or C -Smoking or drug use -Parasite infection -Gastro-intestinal diseases such as IBS or IBD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is pathological response to chemotherapy based on the tumor regression grade. We look at the number of patients with a TRG 1-2 (complete or subtotal response) in both arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy and mechanism of action of fecal capsules in combination with chemotherapy for gastric and esophageal cancer. -Pathological complete response (ypT0N0) -R0 resection rate -Progression-free survival and disease recurrence pattern -Overall survival -Incidence and severity of post-operative complications according to the Clavien - Dindo classification. -Percentage completion of preoperative chemotherapy treatment -Percentage withdrawal rate from surgery -Percentage delay of surgery -Quality of life (EORTC QLQ-C30 summary score) -Adverse events of preoperative chemotherapy treatment Exploratory translational and exploratory biomarker research with tumor biopsies, blood samples and fecal samples from patients. The primary purpose of this is to understand the effect of these capsules on the tumor and the immune system. Tumor biopsies will be used to characterize the immune microenvironment by immunohistochemical stains. Biopsies can be used for DNA and RNA sequencing to investigate gene expression and mutations related to the effectiveness of the capsules. Blood samples will be used to characterize PBMCs by flow cytometry, quantify metabolites and measure cytokines. In addition, cell free DNA can be isolated from blood plasma to detect circulating tumor DNA, which can be used as a biomarker. The tumor biopsies and stool samples will also be used to quantify bacterial populations using 16S sequencing. This will allow for the microbiome to be mapped. The stool from the fecal donors will also be examined to compare the microbiome between patients and donors. | — |
Countries
Netherlands
Contacts
Public ContactS. Siegerink
Amsterdam UMC
Outcome results
None listed