Phase
Condition
Gastric Cancer
Digestive System Neoplasms
Chemotherapy
Treatment
FLOT combined with toripalimab
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
70 ≥ Age ≥ 18 years regardless of gender
Gastric adenocarcinoma confirmed by pathology
no distant metastasis and resectable or potentially resectable evaluated by generalsurgery experts
ECOG PS 0-1
clinical stage T3/4 or N+ by AJCC 8.0
PD-L1 CPS ≥1 (IHC 22C3 pharm Dx assay (Dako))
expected lifespan over 3 months
Adequate organ function: 1) without growth factor and blood component support in thefirst 2 weeks of enrollment; 2) Cardiac function: no heart disease or coronary heartdisease, grade 1-2; 3) liver function: TBIL ≤ 2ULN, AST ≤ 2.5 ULN, alt ≤ 2.5 ULNX 4Renal function: cr ≤ 1.25ULN, liver function: TBIL ≤ 2ULN, TBIL ≤ 2.5ULN, alt ≤ 2.5ULN, 4)renal function: cr ≤ 1.25ULN.
blood pressure normal or controlled within the normal range by antihypertensivedrugs
Diabetic patients were treated with hypoglycemic drugs to control fasting bloodglucose ≤ 8mmol/L
Patients with positive hepatitis B surface antigen need to be tested forquantitative detection of hepatitis B DNA virus. HBV DNA should be less than theupper limit of the normal test value for patients with HBV infection.
no other serious diseases conflicting with this study
No history of other malignant tumors
Women of childbearing age must be tested negative for blood pregnancy test within 7days before enrollment, and subjects of childbearing age must use appropriatecontraceptive measures during the trial and within 6 months after the trial
agreement to participate in this study and signed the informed consent form
Exclusion
Exclusion Criteria:
Pregnant or lactating women
Suffered from severe infectious diseases within 4 weeks before entering the group
Bronchial asthma requires intermittent use of bronchodilators or medicalintervention
Due to the use of immunosuppressants before coexisting diseases and the dosage ofimmunosuppressants ≥ 10mg/, the oral dose of prednisone lasted for more than 2 weeks
Clinically obvious cardio-cerebrovascular diseases, including, but not limited to,severe acute myocardial infarction, instability or severe angina pectoris, coronaryartery bypass surgery, congestive heart failure, ventricular arrhythmias requiringmedical intervention, left ventricular ejection fraction < 50%, stroke within 6months
Allergic to any experimental drug and its excipients, or have a history of severeallergy, or are contraindications to experimental drugs
Severe mental disorders
Abnormal coagulation function (PT > 16s, APTT > 53s, TT > 21s Fib < 1.5g/L),bleeding tendency or undergoing thrombolysis or anticoagulation therapy
Past or present pulmonary fibrosis, interstitial pneumonia, pneumoconiosis,radiation pneumonia, severe impairment of lung function, etc.
Unable to swallow research drugs, chronic diarrhea (including but not limited toirritable bowel syndrome, Crohn's disease, ulcerative colitis) and intestinalobstruction affect drug use and absorption
Have a history of immunodeficiency, including positive for HIV, or suffer from otheracquired, congenital immunodeficiency diseases, or have a history of organtransplant
Other researchers evaluate those who do not meet the criteria for admission
Study Design
Study Description
Connect with a study center
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan 450008
ChinaActive - Recruiting

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