advance gastric carcinoma
Conditions
Interventions
A:Chidamide + tislelizumab + chemotherapy
B:Chidamide + cardonilizumab + chemotherapy
Sponsors
Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form, fully understand and informed the study and sign the informed consent (ICF); Be willing to follow and be able to complete all trial procedures; 2. Male or female, aged =18 years old and =75 years old (on the day of signing the informed consent); 3. Unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma confirmed histologically or cytologically; 4. Histopathologically confirmed HER2-negative. HER2 negativity was defined as negative by IHC(0 or 1+) or fluorescence in situ hybridization (FISH) (HER2:CEP17 ratio <2 and mean HER2 copy number <4.0 signals per cell). FISH can be replaced by in situ hybridization (ISH) that is locally available and considered acceptable by institutional guidelines (e.g., DISH); 5. Patients who had failed previous first-line therapy based on immune checkpoint inhibitor therapy for 6 months or more (neoadjuvant/adjuvant therapy, if progression occurred during therapy or within 6 months after discontinuation of therapy) were considered to have failed first-line therapy. Patients in group B were required to have no previous treatment with cardunnilumab). 6. Eastern Cooperative Oncology Group (EC0G) performance status 0 or 1; 7. Expected survival time =12 weeks; 8. Adequate organ and hematopoietic function according to the following laboratory tests: neutrophil count (NEUT#)=1.5×109/L; White blood cell count (WBC)=3.0×109L; Platelet count =100×109/L; Hemoglobin =90g/ infant; Serum creatinine =1.5 times the upper limit of normal value (ULN); AST, ALT=2.5 times ULN, liver metastasis =5 times ULN; Serum total bilirubin (TBL)=1.5 times ULN; An international normalized ratio (INR) of 2 times the ULN or an activated partial thromboplastin time (APTT) of 1.5 times the ULN(except in patients who are receiving anticoagulant therapy); 9. A negative blood pregnancy test performed within 14 days before treatment in a female patient of reproductive potential. Female participants of childbearing age and male participants whose partner was a woman of childbearing age had to agree to use a highly effective contraceptive method (e.g., oral contraceptives, intrauterine devices, libido control, or barrier contraception combined with spermicids) for 1 year from the time they last received study medication. 10. Good compliance is required.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with HDAC inhibitors; 2. Have an active autoimmune disease (other than psoriasis) requiring systemic therapy (i.e., corticosteroids or immunosuppressive drugs) within the previous 2 years. The exception is replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency). Patients who had major surgery during the 28-day screening period (excluding diagnostic surgery) were expected to be included during the study period. Major surgery was defined as a procedure requiring at least 3 weeks of postoperative recovery before the patient could undergo the study treatment. Known interstitial lung disease or noninfectious pneumonitis treated with corticosteroids; 4. 5. Have a history of human immunodeficiency virus infection, other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or stem cell transplantation; 6. Patients with active chronic hepatitis B or active hepatitis C. Patients with HBV DNA titer =500IU/ ml or <2500 copies /ml were excluded. Active hepatitis C was defined as a known HCV antibody positive and a known HCV RNA quantitative result higher than the lower limit of detection of the analytical method. 7. Subjects with known previous allergies to macromolecular protein preparations/monoclonal antibodies or chemotherapeutic drugs involved in this trial; 8. Within 4 weeks before the first dose of the investigational drug (enrollment in other clinical trials based on the last use of the investigational drug; 9. Alcohol dependence or a history of drug abuse in the past 1 year; 11. Injectable inactivated seasonal influenza vaccine is allowed for patients who received live vaccine within 30 days before the first dose; Live, attenuated, intranasal influenza vaccine was not allowed; 12. Subjects deemed by the investigator to be unfit for the trial for other reasons;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;safety; | — |
Countries
China
Contacts
Public ContactYong Mao
Affiliated Hospital of Jiangnan University
Outcome results
None listed