Unresectable advanced or recurrent esophageal cancer or gastric cancer Esophageal cancer, gastric cancer
Conditions
Interventions
1) Three types of antibiotics (amoxicillin, fosfomycin, metronidazole) will be administered for one week.
1. For amoxicillin, administer 1,500 mg of amoxicillin hydrate orally in 3 divided doses per d
Fecal Microbiota Transplantation
Sponsors
Shoji Hirokazu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for patients 1)Histologically diagnosed as esophageal squamous cell carcinoma or gastric adenocarcinoma. 2)Unresectable advanced or recurrent esophageal cancer or gastric cancer. 3)The patient is capable of oral intake. 4)Age at the time of consent is 18 years or older. 5)ECOG-PS:0-1. 6)Have at least one measurable lesion on contrast-enhanced CT within 28 days prior to enrollment. 7)The administration of anti-PD-1 antibodies (Nivolumab, Pembrolizumab) and anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody (Ipilimumab) for the treatment of unresectable advanced or recurrent esophageal or gastric cancer is scheduled. 8)Laboratory tests performed within 14 days prior to enrollment meet the criteria. However, the patient must not have received granulocyte colony stimulating factor (G-CSF product) administration or blood transfusion within 14 days prior to blood collection. 1 Neutrophil count >= 1500 /mm3 2 Platelet count >= 10x104 /mm3 3 Hemoglobin >= 8.0 g/dL 4 AST (GOT) ==40 ml/min (Cockcroft-Gault estimation formula or 24-hour urine collection) 9)For female of childbearing potential, have agreed to dual contraception, prohibition of egg donation and prohibition of breast feeding from the time of consent until at least 6 months after the last dose of any investigational drug. For male, have agreed to dual contraception and prohibition of sperm donation from the start of investigational drug administration until at least 6 months after the last dose of any investigational drugs. 10)Written consent to participate in the study has been obtained from the patient. Inclusion criteria for donors 1) Healthy persons who are 18 years of age or older at the time of obtaining consent. 2) Persons who can donate stool regularly. 3) Persons who can undergo a medical interview and screening tests (blood test, stool test, and saliva test) on a regular basis 4) Persons who have the capacity to consent and can obtain written consent of their own free will.
Exclusion criteria
Exclusion criteria: Exclusion criteria for patients 1)The patient has an active overlapping cancer. 2)Patients who are severely allergic to the medications utilized in this study. 3)Patients with HER2 postive. 4)Patients with chronic bowel disease and inflammatory bowel disease. 5)Active autoimmune disease or autoimmune disease requiring systemic steroids or immunosuppressive agents. 6)Receiving systemic corticosteroids or immunosuppressive drugs within 14 days prior to enrollment. 7)Receiving systemic cytotoxic therapy within 14 days prior to enrollment. 8)Receiving systemic molecular targeted therapy within 21 days prior to enrollment. 9)Receiving more than 50 Gy of radiation therapy within 28 days prior to registration. However, in the case of irradiation of less than 50 Gy for bone metastases, irradiation was performed within 14 days prior to enrollment in the study. 10)Received a live vaccine within 4 weeks prior to prior to enrollment. 11)Active infection requiring systemic treatment. 12)Positive for HIV antibody, HBs antigen, or HCV antibody. 13)HBs antigen negative, HBs or HBc antibody positive, and HBV-DNA quantification positive. 14)No severe ascites on CT imaging that extends beyond the pelvic cavity to the upper abdomen. No massive ascites or pleural effusion requiring drainage. 15)Patients who are judged to be unsuitable as research subjects by the principal investigator (co-investigator) Donor exclusion criteria 1)Those who are suspected of having a health problem or risk based on an interview regarding their health condition, medical hist ory, treatment history, vaccination history, high-risk behaviors (piercing, needle sticks, unspecified sexual contact), and travel hi story. 2)Those who are suspected of being infected with or carrying the following pathogenic viruses, bacteria, or parasites: Hepatitis A virus, hepatitis B virus, hepatitis C virus, hepatitis E virus, HIV-1,2, HTLV-1, cytomegalovirus, EB virus, syphilis, Myc obacterium tuberculosis, Clostridioides difficile, intestinal tract Hemorrhagic E. coli (O-157), enteroaggregative E. coli (EAEC), e nteropathogenic E. coli (EPEC), enterotoxigenic E. coli (ETEC), Shiga toxin-producing E. coli (STEC), enteroinvasive E. coli (EI EC), Salmonella, Shigella, Yersinia, Campylobacter, Vibrio parahaemolyticus, Vibrio cholerae, Vibrio vulnificus, Plesiomonas shi gelloides, drug-resistant bacteria, adenovirus, norovirus, rotavirus, astrovirus, sapovirus, SARS-CoV-2, parasites (Strylcoccus n ematodes, Giardia triumphalis, Cryptosporidium, Entamoeba histolytica, Cyclospora, and other insect eggs and bodies) 3)Those whose blood test results deviate from standard values for general peripheral blood tests, creatinine, C-reactive protein, A ST, ALT, ALP, total bilirubin, and albumin. 4)Those whose fecal hemoglobin test results are positive for fecal occult blood (for women, the test is performed outside the men strual period) 5)Those who are judged to be unsuitable as research subjects by the research director (sub-researcher)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment limiting toxicity incidence rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Disease control rate, Progression-free survival, Overall Survival | — |
Contacts
Public ContactHirokazu Shoji
National Cancer Center Hospital
Outcome results
None listed