Gastric cancer
Conditions
Interventions
Experimental group:Fecal Microbiota Transplantation combined with sintilimab and XELOX
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1: Voluntarily participate in clinical research; Fully understand and be informed about the study, and sign the Informed Consent Form (ICF); Willing to follow and be capable of completing all experimental procedures. 2: Aged =18 years,no gender limit; 3: The ECOG-PS score is 0-1; 4: The expected survival period is = 3 months; 5: Histologically or cytologically confirmed, locally advanced unresectable or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma (including signet-ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma) 6: Have not received any systematic anti-tumor treatment for advanced/metastatic diseases;patients who have received radical radiotherapy and chemotherapy for advanced diseases,if the disease progresses Those who show more than 6 months after the end of the last treatment are eligible to participate in this study 7: According to the RECIST1.1 criteria for solid tumors, with at least one assessable lesion; 8: Patient was able and willing to provide pathological tissue embedded in wax blocks or paraffin sections; 9: Good organ function: a.Blood routine: hemoglobin =9g/dL, neutrophil =1.5×10^9/L, platelet =100×10^9/L; b.Liver function: total bilirubin (TBIL)=1.5×upper limit of normal (UNL); ALT=2.5×UNL, AST=2.5×UNL(ALT=5×UNL and AST=5×UNL for patients with liver metastasis.) c.Creatinine clearance=60 mL/min d.Coagulation function is fully defined as internationalization ratio (INR) or prothrombin time (PT) = 1.5×ULN. Unless patient was receiving anticoagulant therapy, coagulation indexes were within normal range of therapy. 10: women/men of childbearing age should take effective contraceptive measures during the study period and within 6 months after the end of the study treatment.
Exclusion criteria
Exclusion criteria: 1: Her2-positive gastric and gastroesophageal junction adenocarcinoma ; 2: Other pathological types were confirmed by histopathological examination, such as squamous cell carcinoma, sarcoma or undifferentiated carcinoma; 3: Within 3 years or concurrently with other active malignant tumors. Cured limited tumors such as basal cell carcinoma of the skin, Cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast may be enrolled. 4: Is participating in another clinical study, unless it is an observational, non-interventional clinical study, or follow-up period of an interventional study 5: Received systemic systemic treatment with Chinese herbs with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration; 6: Prior treatment with any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or any other antibodies or drugs targeting T-cell co-stimulation or checkpoint pathways; 7: Patient had an autoimmune disease or a history of autoimmune disease within 2 years; 8: Active or previously documented inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea). Inability to swallow, malabsorption syndrome, or uncontrollable nausea, vomiting, diarrhea, or other gastrointestinal disorders that seriously affect the administration and absorption of medications; 9: Use immunosuppressant or systemic therapy within 14 days before starting the study treatment to achieve immunosuppressive purpose (dose > 10mg/day or other therapeutic effects) 10: The history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation is known; 11: Had major surgery other than the diagnosis of gastric cancer within 4 weeks prior to initial dosing or was expected to require major surgery during the study period; 12: There was a history of gastrointestinal perforation and/or fistula within the 6 months prior to study inclusion 13: Interstitial lung disease requiring steroid therapy; 14: Known presence of active tuberculosis; 15: The presence or suspected presence of uncontrolled or active fungal, bacterial, viral or other infections; 16: Patients with active hepatitis B (defined as serum HBV-DNA=2000 IU/mL), hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV) antibody positive, or active syphilis at enrollment; 17: Active or untreated brain metastases, meningeal metastases, spinal cord compression, or pia are known to exist. 18: Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (= once/month) 19: There were clinically active hemoptysis, active diverticulitis, abdominal abscess, and gastrointestinal obstruction 20: Have clinically significant bleeding symptoms or a definite tendency to bleed within 1 month before the first dose, 21: Patient had severe cardiovascular disease (e.g., drug-uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), bleeding disorders, severe obstructive or restrictive pulmonary diseases, or systemic infections. 22: There was toxicity from previous antitumor therapy that did not return to NCI CTCAE v5.0 for grade 0 or grade 1 before first administration 23: Defined as = grade 2 peripheral
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease Control Rate;Overall survival;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events and Serious adverse event; | — |
Countries
china
Contacts
Public ContactKai Chen
The First Affiliated Hospital of Soochow University
Outcome results
None listed