Gastric cancer
Conditions
Interventions
experimental group:PD-1 mab combined with conventional chemotherapy
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in clinical research; Fully understand and know the study and sign informed consent form (ICF); Willing to follow and able to complete all test procedures; 2. There is no limit on gender, and when signing ICF aged 18-70 years; 3. Patients with unresectable or unresectable locally advanced, recurrent or metastatic adenocarcinoma of stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma and hepatoid adenocarcinoma) confirmed by histopathological examination; 4. Patients with the time from the end of previous (neoadjuvant) chemotherapy / radiotherapy to recurrence > 6 months; 5. Cardiac function is good and patients with underlying ischemic, valvular, or other severe heart disease should be evaluated by a cardiologist if clinically indicated; 6. Subjects must provide tumor tissue at enrollment (repeat screening subjects do not need to undergo PD-L1 testing again) for PD-L1 expression level determination; 7. Anti tumor traditional Chinese medicine, Chinese patent medicine and immunomodulator (such as thymosin, lentinan, interleukin-12, etc.) used in the past must be >= 2 weeks from the end of the study; 8. ECOG PS score within 7 days before the first medication was 0 or 1; 9. Estimated survival time >= 6 months; 10. Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), hepatitis B virus DNA (HBV-DNA) must be = 100 x 10^9/L, Hemoglobin (HB) >= 90 g/L, liver function Total bilirubin (TBIL) = 30 g/L, renal function Creatinine (CR) Normal value range, Coagulation function Activated partial thromboplastin time (APTT) <= 1.5 x Upper normal value (ULN), Prothrombin time (PT) <= 1.5 x Upper normal value (ULN), International normalized ratio (INR) <= 1.5 x Upper normal value (ULN); 13. Female patients were enrolled as follows: The results of serum pregnancy test within 7 days before the first medication must be negative; Patients who agree to use contraceptives with an annual failure rate of < 1% or remain abstinent (avoid heterosexual intercourse) (from menopause (defined as no menstruation for at least 1 year and no other confirmed reason except menopause), or have undergone surgical sterilization (removal of ovaries and / or uterus), or have fertility must also meet the following requirements: Sign the informed consent form until at least 6 months after the last dose of treatment) (contraceptive methods with an annual failure rate of < 1% include bilateral tubal ligation, male sterilization, correct use of hormone contraceptives that can inhibit ovulation, hormone releasing intrauterine devices and copper containing intrauterine devices); Do not breastfeed; 14. Male patients must meet the following requirements: agree to abstinence (avoid heterosexual intercourse) or take contraceptive measures. Contraceptive measures are as follows: when the partner is a
Exclusion criteria
Exclusion criteria: 1. Other active malignant tumors within 5 years or at the same time. Limited localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer in situ, in situ carcinoma of the cervix, and breast cancer in situ, can be included; 2. Patients who are ready for or have previously received organ or bone marrow transplantation; 3. The interval of cardiac arrhythmia (including QTc >= 470 MS in men and QTc = 6 months in women) was calculated according to the formula before the first myocardial infarction; 4. There is NYHA standard grade III-IV cardiac insufficiency or color Doppler echocardiography: LVEF (left ventricular ejection fraction) 10 mg/day prednisone efficacy dose) or other immunosuppressive drugs within 14 days before the first medication or during the study. However, the following conditions are allowed to be included: in the absence of active autoimmune diseases, patients are allowed to use local topical or inhaled steroids, or adrenal hormone replacement therapy with the effective dose of prednisone <= 10mg/day; 11. Any active infection requiring systemic anti infective treatment within 14 days before the first medication; Except for prophylactic antibiotic treatment (such as prevention of urinary tract infection or chronic obstructive pulmonary disease); 12. Previous antibody/drug therapy with immune checkpoints, such as PD-1, PD-L1, CTLA4, etc.; 13. Being treated in other clinical studies or planning to start the treatment of this study is less than 14 days from the end of the treatment of the previous clinical study; 14. Known history of severe allergy to any monoclonal antibody or study drug excipients; 15. Known history of psychotropic substance abuse or drug abuse; Patients who have stopped drinking can be enrolled; 16. There are patients who may increase the risk of participating in the study and study medication, or other severe, acute and chronic diseases, and are judged by the investigator to be unsuitable for participating in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dynamic changes of circulating tumor DNA before and after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;Overall survival;Objective remission rate;Incidence of adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactHao Wu
Jiangsu Province Hospital
Outcome results
None listed