gastric cancer
Conditions
Interventions
A:chidamide + Envafolimab + irinotecan or albumin-paclitaxel
Sponsors
First affiliated hospital of Soochow university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Gastric cancer confirmed by pathology; 2. Over 18 years old, gender unlimited; 3. Expected survival =3 months; 4. ECOG score 0-1; 5. Have at least one measurable lesion that is HER2-negative according to RECIST 1.1 criteria; 6. Second-line treatment, have not previously received irinotecan or paclitaxel based chemotherapy; 7. The main organs function well, that is, the relevant examination indicators within 14 days before enrollment meet the following requirements: Hemoglobin = 90 g/L (no transfusion within 14 days); Neutrophil count > 1.5×109/L; Platelet count = 100×109/L; Total bilirubin = 1.5×ULN (upper limit of normal); Serum glutamic pyruvic aminotransferase (ALT) or serum glutamic oxalacetic aminotransferase (AST) = 2.5×ULN; If there is liver metastasis, ALT or AST = 5×ULN; Endogenous creatinine clearance = 60 ml/min (Cockcroft-Gault formula); Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = 50%. 8. The informed consent is signed and the compliance is good, and the family members agree to cooperate with the survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous or concurrent malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; Patients with small gastric stromal tumors, as well as other early tumors after radical treatment, other tumors that investigators judge will not affect the patient's life in the short term can be excluded. 2. Participated in other drug clinical trials within four weeks; 3. Patients with known or history of central nervous system metastasis prior to screening. For patients with clinically suspected CNS metastasis, CT or MRI examination must be performed within 28 days before enrollment to rule out CNS metastasis. 4. Patients with history of unstable angina pectoris; Patients with newly diagnosed angina pectoris or myocardial infarction within 3 months prior to screening; Arrhythmias (including QTcF: =450 ms in men and =470 ms in women) requiring long-term use of antiarrhythmic drugs and New York Heart Association grade =II cardiac insufficiency; 5. Urine routine indicated urinary protein =++ and confirmed 24-hour urinary protein quantification > 1.0 g; 6. For female subjects: should be surgically sterilized, postmenopausal patients, or consent to use a medically approved contraceptive during the study treatment period and for 6 months after the end of the study treatment period; Serum or urine pregnancy tests must be negative within 7 days prior to study enrollment and must be non-lactating. Male subjects: patients who should be surgically sterilized or who have consented to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period; 7. Used immunotherapy drugs; 8. A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 9. Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients requiring corticosteroids; 10. History of chronic autoimmune diseases, such as systemic lupus erythematosus; History of ulcerative enteritis, Crohn's disease and other inflammatory bowel diseases, irritable bowel syndrome and other chronic diarrheal diseases; A history of sarcoidosis or tuberculosis; History of active hepatitis B, hepatitis C and HIV infection; 11. Patients with hypersensitivity to human or murine monoclonal antibodies; 12. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 13. Pleural effusion or abdominal effusion with clinical symptoms requiring clinical intervention; 14. In the judgment of the investigator, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's completion of the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progressives free survival;overall survival;6 months progression free survival rate;6 months overall survival rate;12 months progression free survival rate;12 months overall survival rate;disease contral rate;quality of life; | — |
Countries
China
Contacts
Public ContactWei Li
First Affiliated Hospital of Soochow University
Outcome results
None listed